Accepted Manuscript

Dosage of preventive or therapeutic exercise interventions: review of published

randomized controlled trials and survey of authors

Marion Gallois, PT, Msc, Thomas Davergne, PT, Msc, Pauline Ledinot, MD, Msc,
Philippe Ravaud, MD, PhD, Professor, Jean-Philippe Regnaux, PT, PhD

PII: S0003-9993(17)30264-2
DOI: 10.1016/j.apmr.2017.03.030
Reference: YAPMR 56874

To appear in: ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION

Received Date: 20 September 2016

Revised Date: 20 March 2017
Accepted Date: 22 March 2017

Please cite this article as: Gallois M, Davergne T, Ledinot P, Ravaud P, Regnaux J-P, Dosage of
preventive or therapeutic exercise interventions: review of published randomized controlled trials and
survey of authors, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2017), doi: 10.1016/
j.apmr.2017.03.030.

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Running Head: Review of dose exercise justifications

Dosage of preventive or therapeutic exercise interventions: review of published

randomized controlled trials and survey of authors

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Authors Full names

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Marion Galloisa, b, PT, Msc

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Thomas Davergnea, b, PT, Msc
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Pauline Ledinota, b, MD, Msc
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Philippe Ravauda, b, d, MD, PhD, Professor

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Jean-Philippe Regnauxa, b, c, PT, PhD

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Affiliations

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CRESS U1153, Inserm, METHODS team, Paris, France
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Sorbonne Paris Cité, faculté de médecine, Paris Descartes University, Paris, France

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EHESP, department SHS, Sorbonne Paris Cité, Paris, France

d
AP–HP (Assistance Publique des Hôpitaux de Paris), hôpital Hôtel Dieu, centre

d’épidémiologie clinique, Paris, France

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Acknowledgements

The authors are grateful to I Pane and M Randrianandrasana for technical assistance. We

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acknowledge L.Trinquart and R.Porcher for statistical advice. We also thank R Haneef and S

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Birnbaum for their valuable comments.

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Author contributions

MG, JP R and PR developed the study concept and research design and wrote the manuscript.

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MG, JP R, TD and PL extracted data. JP R and TD evaluated outcomes. MG and JP R
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provided analysis.
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Funding: Authors declared no funding for this research, no financial benefits.

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Corresponding author & address:

Jean-Philippe Regnaux,
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Hôpital Hôtel Dieu, département d’épidémiologie clinique du Pr Ravaud, 1 Place du Parvis

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Notre Dame, 75004 Paris, France

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Email :jean-philippe.regnaux@aphp.fr

Tel : +33 1 42 34 78 68
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Word count: 3059

Figures: 1

Tables: 5

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1 Dosage of preventive or therapeutic exercise interventions: review of published

2 randomized controlled trials and survey of authors

4 Abstract

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5 Objective: To describe the dose components and choice justifications in exercise interventions

6 (EIs) in a convenient sample of randomized controlled trials (RCTs).

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8 Data Sources: We searched the following databases: PubMed and CENTRAL in 2014.

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10 Study Selection: We included published RCTs evaluating preventive or therapeutic
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11 interventions in people with clinical conditions or at risk to develop health problems.

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13 Data Extraction: Two reviewers independently extracted data and evaluated the adequacy of

14 the justifications. We contacted and invited the trials authors to complete an online survey to
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15 ask for additional information on dose justifications and dose–effect relationship.

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17 Data Synthesis: We included 187 published RCTs. Of these, 68 (36%) reported a justification

18 for the dose choice, 135 (72%) reported three doses components. Most reported components
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19 were duration (96%) and frequency (93%). Sixty-six survey responders (response rate 35%)
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20 provided additional information. When combining the publications and survey responses, 104

21 (56%) trials had a justification for the dose choice. We judged justifications adequate in 45

22 (43%) articles. From the survey responders, 39% indicated that intensity was the dose

23 component that can have the greatest impact on their study results.

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25 Conclusions: Most of the published RCTs adequately reported the dose components of their

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26 EIs but only a small number provided sufficient justifications for dosage choices. Further

27 studies are recommended to justify the EI dose choices.

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29 Keywords: Exercise, Dose choice, Justifications, Relevance, Clinical Trials

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51 The importance of exercise and physical activity in improving physical and mental health has

52 been widely demonstrated [1, 2]. The exercise interventions (EIs) are recommended for

53 clinical populations with various disease conditions (stroke, coronary heart disease,

54 osteoporosis and certain types of cancer) [3] or at great risk of developing health problems

55 (aging, unhealthy lifestyles). Investigators have to deal with methodological limitations

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56 related to exercise's evaluation such as difficulty with blinding interventions or small sample

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57 sizes. Nevertheless new methodologies as SMART trials support the role of exercises and

58 respond to a part of methodological limitations [4, 5]. Investigators have also to identify the

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59 different components that can influence the effectiveness of an EI and also implement

60 research results into clinical practice [6]. The exercises are extremely heterogeneous: they can

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vary in the dosage with types of exercise, components, modes and settings [7].
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62 Benefits and harms can be associated with the dosing of an intervention [8]. A dose of EI
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63 refers to the amount of physical activity delivered for a given task. It is reported in terms of

64 frequency, duration, and intensity (time spent and/or resistance work or effort expended over
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65 a certain period) [9, 10]. Recent research involving EIs reported relationships between dose
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66 and effect size [1]. Current practice has a strong belief in the “more is better” philosophy [11,
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67 12] but higher EI dose can also be harmful [13, 14]. On the other hand, some authors have

68 suggested that low EI doses may be insufficient in inducing significant and clinical effects
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69 [15]. They may explain the lack of efficacy proofs when they are compared to each other or
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70 with others current therapies [16]. The relevance of EI dose choices represents a major

71 concern that can influence study results [17]. Little information is available on the

72 justifications of the EI dose choice in randomized controlled trials (RCTs).

73 The objectives of this study were to: (1) describe the EI dose components and their dose

74 choice justifications reported in RCTs involving people with clinical conditions or at great

75 risk of developing health problems (2) determine if dose choice justifications are adequate and

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76 (3) to obtain more information on the importance of EI dose choices with survey authors of

77 included RCTs.

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79 1. METHODS

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80 1.1 Data sources and searches

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81 We searched MEDLINE via PubMed and the Cochrane register of Controlled Trials

82 (CENTRAL) for published reports of RCTs. We chose these databases because they contain a

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83 large number of RCTs in various health fields, including the main journals publishing trials

84 with EIs.

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85 We searched the databases from July 1 to December 31, 2014, to evaluate recent published

86 articles with a valid author email address. We limited the search due to the large number of
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87 citations to be screened for eligibility.

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88 The search strategy included the terms “exercise,” “exercise therapy,” “exercise movement
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89 techniques,” “physical fitness,” “resistance training,” “physical endurance,” “physical

90 activity,” “physical therapy.” (Search equations in supplementary file 1.)

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91
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92 2.2 Sample Selection

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93 We searched RCTs evaluating preventive or therapeutic EIs in people with clinical conditions

94 or at great risk to develop health problems. EIs were defined according to the definition

95 provided by Wolin [18]: “as any body movement causing an increase in energy expenditure

96 that involves a planned or structured movement of the body performed in a systematic manner

97 in terms of frequency, intensity, and duration, and is designed to maintain or enhance health-

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98 related outcomes”. We included EIs that aimed to increase physical activity “with the

99 intention of improving or maintaining physical fitness or health” [19], either alone or as an

100 adjunct to pharmacological treatment or other interventions. We included all trials with at

101 least one EI performed in the experimental arm, with any type of comparator and regardless

102 of outcome measures. All RCTs published in English, French, or Spanish were retrieved. We

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103 excluded studies with healthy subjects. EIs that involved passive range of motion (e.g.,

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104 passive stretching) or low energy expenditure (i.e. posture) techniques alone were not eligible.

105 Studies were excluded when we could not retrieve the full text article after contacting authors

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106 via email or when we could not find contact information about the principal investigator or

107 study director.

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108 One reviewer (MG) read all the titles and abstracts of selected eligible studies. Using a

109 computer-generated list created with the SAS program (SAS 9.3; SAS Institute Inc), we
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110 randomly selected a sample of 200 studies from the selected trials. It constituted a broad

111 sample of EIs that was technically manageable by our team. A first reviewer (MG) screened
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112 the full text articles and determined the studies to include. A second reviewer (JPR)
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113 independently assessed all reports (n=13) that were either excluded or not clear (full text or
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114 email contact was not available, not a RCT, study population or intervention not eligible).

115 There was no disagreement between reviewers. We excluded duplicates using an EndNote
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116 library.
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120 2.3 Data Extraction

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121 For each published RCT, a pair of two independent researchers (MG, TD, PL, and JPR)

122 extracted the data. A third researcher resolved any disagreement about extracted data. We

123 used a standardized data collection form (Supplementary materials 2). We extracted the

124 characteristics of the journal (impact factor), trial (registration, language, geographic area,

125 funding source, study design, hypothesis and clinical domains), EI (combination, number of

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126 arms, dose), EI dose choice justification (type, dose components concerned, location),

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127 comparators (type).

128 We categorized clinical domains with the Cochrane Database of Systematic Reviews topic

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129 classification and types of EI according to ProFANE because they cover all diseases and EI

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130 categories respectively, in the RCTs evaluating EI effects [20].
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131 We extracted key components of the EI dose (intensity, frequency, duration) and the types of

132 justifications given for dose choices (Efficacy study, Clinical guidelines, Tolerability, Dose-
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133 finding research, Systematic review, Current practice, Personal experience).

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134 We tested the data collection form for correct extraction between reviewers before the
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135 extraction step with a sample of 10 full texts that were excluded from our final selection

136 results.
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137 Because EI components are often incompletely described and reported in published RCTs [17,
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138 21], an email advertisement was sent to each author of included RCTs to invite them to
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139 participate in an online survey. They were instructed that this survey was created to determine

140 the EI dose choice justification delivered in their published RCTs. A link to the questionnaire

141 was provided at the end of the message. By following the link to the questionnaire and

142 completing it, they provided informed consent.

143 We developed a web-based online survey including seven close-ended questions each with a

144 single choice. Two questions asked about their beliefs concerning whether dose-response
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145 relationships could influence their study results. Five questions requested additional

146 information on the justification of the EI dose choice reported in their published RCT. If no

147 response was received within ten days after the first email, two reminder emails were sent to

148 two weeks apart. Email invitations and web-survey forms are available as additional files

149 (supplementary materials 3). Two researchers (TD, JPR) evaluated whether the justifications

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150 reported in the published RCTs and/or in answers from authors were adequate with regards to

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151 the same population, intervention or outcome (PICO criteria). The researchers’ judgment was

152 expressed on a 5-point Likert scale: strongly disagree, disagree, not verifiable, agree, and

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153 strongly agree. Justifications with a “strongly agree” or “agree” were considered adequate. All

154 differences were discussed in order to obtain consensus. The discrepancies (n=19) were

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limited between readers for justifications of EI dose reported in the articles. The reasons for
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156 disagreement concerned: no reference to the justification or could not be verified (n=10),
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157 inappropriate study population or EI between the published RCTs and the author’s

158 justification (n=8), incomplete dose component justification (n=1).

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159
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160 2.4 Data Synthesis and Analysis

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161 We performed descriptive analysis to explore: the EI dose components, the types of
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162 justifications and the answers provided by included RCT authors. Categorical variables were
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163 presented as numbers and percentages (%) and continuous variables with medians and

164 interquartile ranges.

165 We conducted univariate linear regression or Fisher’s exact test (categorical variables)

166 analysis to explore associations between trial characteristics and justifications of the dose

167 choices. The following trial characteristics were investigated: trial location, clinical domains,

168 funding sources, types of comparator, study designs, number of arms, study hypothesis, EI

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169 modalities, journal characteristics (impact factor) and dose characteristics (variable dose,

170 individualized dose). All statistical tests were two-sided. A p-value <0.05 was considered

171 statistically significant. Statistical analyses were performed using R version 3.1.0 (R project

172 available at www.r-project.org).

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174 2. RESULTS

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175 3.1 Search

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176 The initial search (MEDLINE and CENTRAL) retrieved 6323 published trials (Figure1). We

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177 identified 691 trials, which met the inclusion criteria after reading the title and abstracts. We
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178 randomly selected a sample of 200 trials that evaluated the effects of EIs. We included 187

179 RCTs after reading the full text (supplementary materials 4a & 4b). We excluded 13 reports
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180 owing to no email contact available (n=2); no access to full text articles (n=4), inappropriate

181 study design (n=4), healthy subjects (n=1), no exercise programs delivered (n=2).
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182 &&&&&&&&&&&&&&&&&

183 Please, insert Figure 1, here

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184 &&&&&&&&&&&&&&&&&
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185
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186 3.2 General characteristics of published RCTs

187 Main trial characteristics of the included RCTs are presented in Table1. Among 187 published

188 trials, the most clinical domains evaluating EI effects were: 25(13.4%) on the heart and

189 circulation, 23(12.3%) endocrine and metabolic, 23(12.3%) neurology, 23(12.3%) public

190 health, 23(12.3%) rheumatology. Most trials were funded (65%, 122/187), with parallel

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191 groups (94%, 176/187), testing a directional hypothesis (68%, 126/187) and with two arms

192 (78%). Forty percent (75/187) had a passive control intervention.

193 &&&&&&&&&&&&&&&&&

194 Please, insert table 1, here

195 &&&&&&&&&&&&&&&&&

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196

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197 3.3 Reporting of exercise dose in published RCTs

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198 From the 187 published RCTs, 135 (72%) reported all three-dosage components (amount,

199 frequency and duration) of the EIs. Duration (96%, 180/187) and frequency (93%, 174/187)

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were the most frequent components reported among the published RCTs (Table 2).
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201 &&&&&&&&&&&&&&&&&
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204
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205 3.4 Dose choice justification of exercise interventions and adequacy of reporting in
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206 published RCTs

207 The dose choice justification of EIs was reported in 68 (36%) of the 187 published RCTs
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208 (Table 3). Of these 68 trials, 61 (90%) provided a justification from the methods section, 4
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209 (6%) from the discussion and 2 (3%) from the introduction. Only 4 (6%, 6/68) of the 68 trials

210 justified all 3-dosage components of EIs and 45 (66%, 45/68) justified only one component.

211 The most common justification reported was: from previous published studies (31%, 21/68)

212 or recommendations (31%, 21/68). The remaining justifications (dose finding, systematic

213 reviews, current practice, and personal experience) were cited by less than 10% of the

214 included RCTs.

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215

216 &&&&&&&&&&&&&&&&&

217 Please, insert Table 3, here

218 &&&&&&&&&&&&&&&&&

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220 Studies using individualized dosages were more likely to justify the dose choice (58/68 [85%]

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221 vs 70/119 [59%], p=0.0004) than those delivering fixed dosages. No significant effect was

222 found with other variables (Table 4).

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223

224 &&&&&&&&&&&&&&&&&
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225 Please, insert table 4, here
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226 &&&&&&&&&&&&&&&&&

227
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228 3.5 Survey responses from trial authors on the dose choice of exercise interventions
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229 From the online survey, 35% (66/187) of authors responded to our questionnaire (Table5).
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230 Among these 66 authors, we obtained 62 (90%, 62/66) justifications for EI dose choice and 36

231 (20%, 36/187), which were not initially reported in the published RCTs. No change was found
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232 for 26 authors, and 4 did not answer the question.

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239

240 From data extraction and survey responses, we identified 104 (56%, 104/187) justifications in

241 the 187 published RTCs, 83 (44%, 83/187) did not report justification for the EI dose choice.

242 Of these 104 trials with justification, 45 (43%, 40/104) cited an adequate justification for the

243 dose choice of their EI, 20 (20%, 20/104) were inadequate regarding the population or the

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244 intervention and 39 (37.5%, 38/104) could not be verified.

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245 Fifty-eight survey responders provided data on the importance of the EI dose components.

246 According to the survey responses, study results can be affected by a dose-effect relationship

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247 (88%, 58/66). Twenty-six responders (39%, 26/66) indicated intensity could have the greatest

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248 impact on their study results; 17 responders cited frequency (26%, 17/66), 9 cited duration
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249 (14%, 9/66) and 12 responders (18%, 12/66) had no opinion.

250
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251 3. DISCUSSION
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252 Our random sample of published RCTs offered an opportunity to determine the reporting of
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253 EI dose components and the justification of the dose choices. Our results show that most
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254 published RCTs adequately reported the different EI dose components delivered but poorly

255 justified (43%) their dose choice. The majority of justifications were based on efficacy studies
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256 or clinical guidelines. The proportion of adequate justifications reported increased to 43%
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257 after having contacted each author. The majority of the published RCT authors declared that

258 the dose-effect relationship could affect their study results. Moreover, two components;

259 intensity and frequency of EI may have an impact on the dose-response relationship, although

260 they did not systematically report these components.

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262 4.1 Exercise intervention dose reporting components

263 Our results revealed that EI dose components were well reported (72%) in published RCTs.

264 EI is a non-pharmacological intervention (NPI) that includes different components which are

265 not frequently described extensively enough to replicate and implement in clinical practice

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266 [22, 23]. Slade et al. studied the quality of description in articles and showed that only 29% of

267 systematic reviews could adequately describe the EI. They explained that only a limited

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268 number of trials included in systematic reviews described the important components such as

269 the dosage, progression rules or degree of supervision [24]. Several guidelines and checklists

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270 [21, 25] have been developed to improve the reporting and produce better-quality evidence.

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271 One of the first projects was the CONSORT statement, followed by the extension for NPIs
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272 [26]. These guidelines included several items specifically concerning the dosage components,

273 which could explain the high frequency of EI dosage components as reported in our review.
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274 However, no item concerning the justification for the EI dosage was developed. In our sample

275 of RCTs, authors highlighted the importance of the dose-effect relationship. Despite its
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276 importance, the EI dose choice does not seem to be justified; only 36% directly reported
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277 justifications in their published RCT and up to 56% with our survey.
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278
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279 4.2 Exercise intervention dose justification

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280 Combining the published RCT results and author responses, we found that 56% of the trials

281 offered a justification for the EI dose, of which, 43% were appropriate according to expert's

282 review. Most of the authors used efficacy studies and clinical guidelines for their justification.

283 Justifications provided were not supported by dose-finding research but rather by consensus

284 and direct comparison. A limited number of clinical trials or systematic reviews have

285 supported a dose-effect relationship between EIs and health outcomes (benefits and harms)

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286 revealing the importance to study this dose-effect relationship [27-31]. The current data

287 showed that the effects of EI might vary depending on the intensity. For instance, Carayol et

288 al. found [27] that moderate physical exercise was more efficacious than a higher dose for

289 addressing psychological effects in women with breast cancer. Davis et al. [28] compared a

290 high and low duration of aerobic training (40 vs. 20 min/d) in overweight and obese children

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291 and found that a high dose favored less insulin resistance. However, which intensity is more

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292 beneficial is unclear as available data is from studies examining different populations. Many

293 studies have individualized the dose of EI. In this case, the dose-effect relationship is difficult

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294 to explore. The lack of specific dose determination guidelines may support why authors did

295 not systematically propose justifications for their EI dose.

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296

297 4.3 Study Limitations

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298 Our study has several limitations. First, our data are limited to EIs evaluated in published
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299 RCTs. We did not include other types of methodological designs (observational, systematic
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300 reviews) in order to constitute a manageable and homogenous sample of trials. Our results

301 may not be extended to other types of research. We included 200 studies by randomly
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302 selecting them in a larger sample leading to the exclusion of the majority of eligible studies.
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303 No sample size calculation was performed which can limit our results. Nevertheless, we chose
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304 a convenient sample that was manageable by our team resources. Finally, we also defined

305 non-verifiable justifications as inadequate, which could underestimate the frequency of

306 justifications. For example, after internal discussion, our team did not classify individualized

307 EI as a dose justification, while some authors considered it to be a form of dose finding.

308 However, we systematically explored the justifications of the selected EI dose from a

309 representative sample of recent RCTs. We verified whether the justifications were associated

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310 with any reporting or design factors. We also found that contacted authors can improve

311 information and encourage a high response rate by using questions that required no more than

312 5 minutes to respond to an online survey. Despite this, we had a low response rate. A

313 substantial number of authors did not respond to our email invitation even after two

314 reminders.

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315 Conclusions

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316 Our results suggest that most published RCTs adequately reported the EI dose components.

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317 However, fewer had an appropriate justification explaining the EI dose choice and did not rely

318 on evidence-based determination. It is possible that this EI dose may not be cited because

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319 newer strategies to determine the dose have yet to be investigated. The EI dose choice should
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320 be transparent and informed by dose-finding studies. Specific dose determination designs to

321 determine a minimal efficacy and a maximal tolerability are required.

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382 review and practical treatment(s). PLoS Med, 2014. 11(8): p. e1001690.
383 24. Slade, S.C., et al., Standardised method for reporting exercise programmes: protocol
384 for a modified Delphi study. BMJ Open, 2014: p. 4:e006682.

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385 25. Hoffmann, T.C., et al., Better reporting of interventions: template for intervention
386 description and replication (TIDieR) checklist and guide. BMJ, 2014. 348: p. g1687.
387 26. Boutron, I., et al., Extending the CONSORT statement to randomized trials of
388 nonpharmacologic treatment: explanation and elaboration. Ann Intern Med, 2008.

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389 148(4): p. 295-309.
390 27. Carayol, M., et al., Psychological effect of exercise in women with breast cancer
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391 receiving adjuvant therapy: what is the optimal dose needed? Ann Oncol, 2013. 24(2):
392 p. 291-300.
393 28. Davis, C.L., et al., Exercise dose and diabetes risk in overweight and obese children: a
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394 randomized controlled trial. JAMA, 2012. 308(11): p. 1103-12.

395 29. Kwakkel, G., et al., Effects of augmented exercise therapy time after stroke: a meta-
396 analysis. Stroke, 2004. 35(11): p. 2529-39.
397 30. Lohse, K.R., C.E. Lang, and L.A. Boyd, Is more better? Using metadata to explore
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398 dose-response relationships in stroke rehabilitation. Stroke, 2014. 45(7): p. 2053-8.

399 31. Veerbeek, J.M., et al., Effects of augmented exercise therapy on outcome of gait and
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400 gait-related activities in the first 6 months after stroke: a meta-analysis. Stroke, 2011.
401 42(11): p. 3311-5.
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405 &&&&&&&&Figure Legends
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408 Figure 1: Flow diagram for study selection

409
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411 &&&&&&&&Table Legends

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413 Table 1: General characteristics of published randomized controlled trials (RCTs)

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414 Table 2: Specifications of the dose component justifications of exercise interventions
415 reported in published randomized controlled trials (RCTs)

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416 Table 3: Reported dose choice justifications of exercise interventions in published
417 randomized controlled trials (RCTs).

418 Table 4: Univariate analysis for the justification of the dose choice of exercise
419
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420 Table 5: Survey responses for dose choice justifications of exercise interventions in
421 randomized controlled trials (RCTs) published in 2014.
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Table 1:

General characteristics Number of Published RCTs (%)

(n=187)
Clinical domains
Heart and circulation 25 (13.4)
Endocrine and metabolic 23 (12.3)

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Neurology 23 (12.3)
Public health 23 (12.3)
Rheumatology 23 (12.3)

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Orthopedics and trauma 14 (7.5)
Mental health 12 (6.4)

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Kidney disease 10 (5.3)
Lungs and airways 9 (4.8)
Cancer 8 (4.3)
Child health 6 (3.2)
Tobacco drugs alcohol
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3 (1.6)
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Gastroenterology 2 (1.1)
Gynecology 2 (1.1)
Blood disorders 1 (0.5)
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Infectious disease 1 (0.5)

Pain and anesthesia 1 (0.5)
Pregnancy and childbirth 1 (0.5)
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Journal impact factor 2.4 (1.6–3.7)

median (IQR)
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Funding sources
YES 122 (65)
NO 8 (4)
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Not reported 57 (31)

Comparator(s)
Passive treatment or nothing 75 (40)
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Active EI 62 (33)
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Usual care 33 (18)

Sham intervention †† 7 (4)
Not described 10 (5)
Parallel groups 176 (94)

Total number of arms

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3
34 (18)
>3
7 (4)
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Number of arms with EI
1
107 (57)
2
74 (40)
>3
6 (3)
Different(s) EI dose(s) tested 8 (4)

Hypothesis
Directional 126 (68)

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Non-directional 2 (1)
Unclear 59(31)
Geographic area

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Europe 65 (35)
North America 39 (21)

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South America 24 (13)
East Asia 22 (12)
Middle East 15 (8)

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Pacifica 14 (7)
Other 8 (4)
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Abbreviations : IQR, interquartile range EI, exercise intervention

†† For example: Control group have the same intervention than the intervention group but with low intensity to be consider as a sham
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intervention (Adamopoulos, S., et al., Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart
failure: The Vent-HeFT trial: a European prospective multicentre randomized trial.Eur J Heart Fail, 2014. 16(5): p. 574-82).
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Table 2:

Number of Published RCTs (%)

(n = 187)
Dose components reported
Amount 142 (76)
Frequency 174 (93)

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Duration 180 (96)
Number of dose components reported
Three components 135 (72)

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Two components 40 (21)
duration, frequency 35 (88)

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duration, amount 4 (10)
frequency, amount 1 (2)
One component 11 (6)
amount 2 (18)

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frequency 3 (27)
duration 6 (55)
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Table 3:

Number of published RCTs(%)

(n = 187)
Presence of justification 68 (36)
Types of justifications*
Efficacy study 21 (31)
Clinical guidelines 21 (31)

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Tolerability reasons 9 (13)
Dose-finding research 7 (10)
Systematic review 7 (10)

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Current practice 2 (3)
Personal experience 1 (2)
Dose component † justified

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One dose component 45 (66)
amount 37 (82)
frequency 2 (5)

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duration 6 (13)
Two dose components 17 (25)
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duration and frequency 7 (41)
frequency and amount 6 (35)
duration and amount 4 (24)
4 (6)
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Three dose components

Unclear 2 (3)
Article section location
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of the justification*
Methods 61 (90)
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Discussion 4 (6)
Introduction 2 (3)
Appendix 1 (1)
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† Dose components: amount, frequency and duration

* n=68 for justifications in published RCTs
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Table4:

Variables Number of Published Number of Published Univariate

RCTs with RCTs without analysis
justification (%) justification (%) P-value
(n=68) (n=119)
Clinical domain†
Heart and circulation 9 (13) 16 (13) 0.97
Endocrine / metabolic 10 (15) 13 (11)

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Neurology 7 (10) 16 (13)
Public health 8 (12) 15 (13)
Rheumatology 9 (13) 14 (12)

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Others 25 (37) 45 (38)
Journal impact factor 2.5[1.6 – 3.5] 2.4 [1.7 – 4.0] 0.23
median (IQR)

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Funding source
YES 44 (65) 78 (66) 1
NO 3 (4) 5 (4)

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Not reported 21 (31) 36 (30)
Combined exercise‡ 35(51) 68(57) 0.54
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Variable dose ‡‡
YES 44 (65) 58 (49) 0.07
NO 13 (19) 26 (22)
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Unclear 11 (16) 35 (29)

Individualized dose
YES 58 (85) 70 (59) 0.0004
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NO 5 (7.5) 17 (14)
Unclear 5 (7.5) 32 (27)
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Comparator(s)
Passive treatment or nothing 27 (40) 48 (40) 0.25
Active EI 28 (41) 34 (29)
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Usual care 8 (12) 25 (21)

Sham intervention 3 (4) 4 (3)
Not described 2 (3) 8 (7)
Parallel Group 51 (75) 90 (76) 1
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Total number of arms

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2 53 (78) 93 (78) 0.44

3 14 (21) 20 (17)
>3 1 (1) 6 (5)
Number of arms with EI
1 35 (52) 72 (61) 0.41
2 30 (44) 44 (37)
>3 3 (4) 3 (2)
Hypothesis
Directional 47 (69) 79 (66) 0.88
Non directional 1 (2) 1 (1)
Unclear 20 (29) 39 (33)
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Geographic area
Europe 20 (29) 45 (38) 0.47
North America 12 (18) 27 (23)
South America 13 (19) 11 (9)
East Asia 9 (13) 13 (11)
Middle East 6 (9) 9 (8)
Pacifica 6 (9) 8 (7)
Other 2 (3) 6 (5)
Abbreviations : IQR, interquartile range, EI, exercise intervention

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† to perform statistical analysis, we have used a grouped variable “Others”( including Orthopedics and trauma, Mental health, Kidney
disease, Lungs and airways, Cancer, Child health, Tobacco drugs alcohol, Gastroenterology, Gynecology, Blood disorders, Infectious
disease, Pain and anesthesia, Pregnancy and childbirth)

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‡Combination of different types of exercises (Endurance, resistance, flexibility),

‡‡Investigator plan to vary the dose during the exercise program,

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Table 5:

Additional information from online Number of published RCTs (%)

survey (n=66)
Variable dose * 36 (54)
Individualized dose 41 (62)
Justification for dose choice 62 (94)
⇒ Types of justification

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Efficacy study 20 (32)
Clinical guidelines 17 (27)
Tolerability reasons 5 (8)

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Dose-finding research 4 (7)
Systematic review 3 (5)
Current practice 3 (5)

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Personal experience 8 (13)
Others 2 (3)
Does the dose-effect relationship

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affect study results
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YES 58 (88)
NO 2 (3)
I don’t know 6 (9)
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Dose element with the potential

greatest impact on the dose-effect
relationship
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Intensity 26 (39)
Frequency 17 (26)
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Duration 9 (14)
None of these 2 (3)
Don’t know 12 (18)
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* Investigators planned to vary the dose during the exercise intervention

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Figure1

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1 Supplementary materials 1: Search equations

3 MEDLINE via PubMed

4 #1,"Search randomized controlled trial[Publication Type]",382280,

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5 #2,"Search controlled clinical trial[Publication Type]",88450,

6 #3,"Search randomized[Title/Abstract]",337000,

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7 #4,"Search placebo[Title/Abstract]",163962,

8 #5,"Search drug therapy [sh]",1730202,

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9 #6,"Search randomly[Title/Abstract]",228209,

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10 #7,"Search trial[Title/Abstract]",383540, AN
11 #8,"Search groups[Title/Abstract]",1458113,

12 #9,"Search (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8)",3519218,

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13 #10,"Search (animals [mh] NOT humans [mh])",3976159,

14 #11,"Search (#9 NOT #10)",3029562,

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15 #12,"Search exercise[MeSH Terms]",122548,

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16 #13,"Search exercis*[Title/Abstract]",210329,
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17 #14,"Search exercise therapy[MeSH Terms]",31359,

18 #15,"Search ""exercise therapy""[Title/Abstract]",2073,

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19 #16,"Search ""exercise therapies""[Title/Abstract]",54,

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20 #17,"Search exercise movement techniques[MeSH Terms]",5424,

21 #18,"Search ""exercise movement techniques""[Title/Abstract]",0,

22 #19,"Search ""exercise movement technics""[Title/Abstract]",0,

23 #20,"Search resistance training[MeSH Terms]",3589,

24 #21,"Search ""resistance training""[Title/Abstract]",4013,

25 #22,"Search physical endurance[MeSH Terms]",25150,

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26 #23,"Search ""physical endurance""[Title/Abstract]",290,

27 #24,"Search ""physical endurances""[Title/Abstract]",0,

28 #25,"Search physical fitness[MeSH Terms]",22201,

29 #26,"Search ""physical fitness""[Title/Abstract]",6125,

30 #27,"Search ""physical activity""[Title/Abstract]",61480,

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31 #28,"Search ""physical activities""[Title/Abstract]",4023,

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32 #29,"Search physical activity[MeSH Terms]",199759,

33 #30,"Search modality, physical therapy[MeSH Terms]",127225,

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34 #31,"Search ""modality, physical therapy""[Title/Abstract]",0,

35 #32,"Search ""physical therapy""[Title/Abstract]",11653,

36
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#33,"Search (#12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21
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37 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR
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38 #32)",495567,

39 #34,"Search (""2014/07/01""[Date - Publication] : ""2014/12/31""[Date -

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40 Publication])",615974,
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41 #35,"Search (#11 AND #33 AND #34)",4214,

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42 CENTRAL

43 #1 MeSH descriptor: [Exercise] explode all trees 14146

44 #2 MeSH descriptor: [Exercise Therapy] explode all trees 7322

45 #3 MeSH descriptor: [Exercise Movement Techniques] explode all trees 1283

46 #4 MeSH descriptor: [Resistance Training] explode all trees 1230

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47 #5 MeSH descriptor: [Physical Endurance] explode all trees 4240

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48 #6 MeSH descriptor: [Physical Fitness] explode all trees 2165

49 #7 MeSH descriptor: [Motor Activity] explode all trees 16393

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50 #8 "exercise":ti,ab,kw (Word variations have been searched) 42818

51 #9 exercise therapy:ti,ab,kw (Word variations have been searched) 15369

52 #10
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"resistance training":ti,ab,kw (Word variations have been searched) 2884
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53 #11 "physical endurance":ti,ab,kw (Word variations have been searched) 2483
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54 #12 "physical fitness":ti,ab,kw (Word variations have been searched) 2683

55 #13 "physical activity":ti,ab,kw (Word variations have been searched) 8033

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56 #14 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13

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57 50751

58 #15 MeSH descriptor: [Physical Therapy Modalities] explode all trees 16188
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59 #16 "physical therapy":ti,ab,kw (Word variations have been searched) 4220

60 #17 #14 or #15 or #16 Publication Year from 2014 to 2014, in Trials 2109
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63 Supplementary materials 2: Standardized data collection form

64
1 General information

1.1 Registration

1.2 Language

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1.3 Geographic area

1.4 Funding source

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1.5 Impact Factor

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2 Study design

2.1 Design

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2.2 Hypothesis
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2.3 Clinical domain

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3.1 Organization • Was the following exercise programs combined?

• How many arms were in the trial?
•
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How many arms with Exercise program were in the

trial?
•
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3.2 Exercise Mode/type of the exercise program

characteristics • Are the following items clearly described?
- Duration of treatment
- Frequency of treatment
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- Intensity of treatment
3.3 Dose characteristics • Variable dose
• Individualized dose
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• Different(s) exercise program dose(s) tested

4 Justification of the • Is there an explicit justification of the dose selection?
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dose selection • If yes, what is this type?

• What is(are), among the dose elements, those
concerned by the justification?
• Where is the justification in the body of article?
5 Comparator • What is the comparator?

65
66

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68 Supplementary materials 3: Online survey sent to the authors of published article

69

70

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75 Supplementary materials 4a: Included published randomized controlled trials (n=187)
76 after random selection

77

78 Abrahin, O., et al., Single- and multiple-set resistance training improves skeletal and
79 respiratory muscle strength in elderly women. Clin Interv Aging, 2014. 9: p. 1775-82.

80

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81 Abrantes, A.M., et al., A preliminary randomized controlled trial of a behavioral exercise
82 intervention for smoking cessation. Nicotine Tob Res, 2014. 16(8): p. 1094-103.

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83

84 Adamopoulos, S., et al. (2014) Combined aerobic/inspiratory muscle training vs. aerobic

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85 training in patients with chronic heart failure: The Vent-HeFT trial: A European prospective
86 multicentre randomized trial. European journal of heart failure, 574-82 DOI:
87 http://dx.doi.org/10.1002/ejhf.70.

88
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89 Ahmad, T., et al. (2014) The effects of exercise on cardiovascular biomarkers in patients with
90 chronic heart failure. American heart journal, 193-202.e1 DOI: 10.1016/j.ahj.2013.10.018.
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91

92 Alvarez-Barbosa, F., et al., Effects of supervised whole body vibration exercise on fall risk
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93 factors, functional dependence and health-related quality of life in nursing home residents
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94 aged 80+. Maturitas, 2014. 79(4): p. 456-63.

95
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96 Amin, S., et al., A controlled study of community-based exercise training in patients with
97 moderate COPD. BMC Pulm Med, 2014. 14: p. 125.

98
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99 Angadi, S.S., et al., High-intensity interval training vs. moderate-intensity continuous exercise
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100 training in heart failure with preserved ejection fraction: A pilot study. J Appl Physiol (1985),
101 2014: p. jap 00518 2014.

102

103 Ansai, J.H. and J.R. Rebelatto, Effect of two physical exercise protocols on cognition and
104 depressive symptoms in oldest-old people: A randomized controlled trial. Geriatr Gerontol
105 Int, 2014.

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107 Aoike, D.T., et al., Impact of home-based aerobic exercise on the physical capacity of
108 overweight patients with chronic kidney disease. Int Urol Nephrol, 2015. 47(2): p. 359-67.

109

110 Arca, E.A., et al. (2014) Aquatic Exercise is as Effective as dry Land Training to Blood
111 Pressure Reduction in Postmenopausal Hypertensive Women. Physiotherapy Research
112 International, 93-8 DOI: http://dx.doi.org/10.1002/pri.1565.

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114 Arcoverde, C., et al. (2014) Treadmill training as an augmentation treatment for Alzheimer's

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115 disease: A pilot randomized controlled study. Arquivos de neuro-psiquiatria, 190-6 DOI:
116 http://dx.doi.org/10.1590/0004-282X20130231.

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117

118 Awick, E.A., et al., Differential exercise effects on quality of life and health-related quality of
119 life in older adults: a randomized controlled trial. Qual Life Res, 2015. 24(2): p. 455-62.

120
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121 Baria, F., et al. (2014) Randomized controlled trial to evaluate the impact of aerobic exercise
122 on visceral fat in overweight chronic kidney disease patients. Nephrology Dialysis
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123 Transplantation, 857-64 DOI: http://dx.doi.org/10.1093/ndt/gft529.

124
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125 Battaglia, C., et al., Participation in a 9-month selected physical exercise programme enhances
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126 psychological well-being in a prison population. Crim Behav Ment Health, 2014.

127
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128 Battaglia, G., et al. (2014) Changes in spinal range of motion after a flexibility training
129 program in elderly women. Clinical interventions in aging, 653-60 DOI:
130 http://dx.doi.org/10.2147/CIA.S59548.
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131
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132 Batterham, A.M., et al., Effect of supervised aerobic exercise rehabilitation on physical fitness
133 and quality-of-life in survivors of critical illness: an exploratory minimized controlled trial
134 (PIX study). Br J Anaesth, 2014. 113(1): p. 130-7.

135

136 Beneck, G.J., et al., Intensive, progressive exercise improves quality of life following lumbar
137 microdiskectomy: a randomized controlled trial. Clin Rehabil, 2014. 28(9): p. 892-901.

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139 Bennell, K.L., et al. (2014) Neuromuscular versus quadriceps strengthening exercise in
140 patients with medial knee osteoarthritis and varus malalignment: A randomized controlled
141 trial. Arthritis and Rheumatology, 950-9 DOI: http://dx.doi.org/10.1002/art.38317.

142

143 Berg, S.K., et al., Clinical Effects and Implications of Cardiac Rehabilitation for Implantable
144 Cardioverter Defibrillator Patients: A Mixed-Methods Approach Embedding Data From the
145 Copenhagen Outpatient ProgrammE-Implantable Cardioverter Defibrillator Randomized

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146 Clinical Trial With Qualitative Data. J Cardiovasc Nurs, 2014.

147

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148 Bernstein, A.M., et al., Management of prediabetes through lifestyle modification in
149 overweight and obese African-American women: the Fitness, Relaxation, and Eating to Stay

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150 Healthy (FRESH) randomized controlled trial. Public Health, 2014. 128(7): p. 674-7.

151

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152 Blodt, S., et al. (2014) Qigong versus exercise therapy for chronic low back pain in adults-a
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153 randomized controlled non-inferiority trial. Journal of alternative and complementary
154 medicine (New York, N.Y.), A52 DOI: http://dx.doi.org/10.1089/acm.2014.5136.

155
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156 Bocca, G., et al., Three-year follow-up of 3-year-old to 5-year-old children after participation
157 in a multidisciplinary or a usual-care obesity treatment program. Clin Nutr, 2014. 33(6): p.
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158 1095-100.
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159

160 Bohm, C., et al., Effects of intradialytic cycling compared with pedometry on physical
161 function in chronic outpatient hemodialysis: a prospective randomized trial. Nephrol Dial
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162 Transplant, 2014. 29(10): p. 1947-55.

163
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164 Bonura, K.B. and G. Tenenbaum, Effects of yoga on psychological health in older adults. J
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165 Phys Act Health, 2014. 11(7): p. 1334-41.

166

167 Boss, H.M., et al. (2014) Safety and feasibility of post-stroke care and exercise after minor
168 ischemic stroke or transient ischemic attack: MotiveS & MoveIT. NeuroRehabilitation, 401-7
169 DOI: http://dx.doi.org/10.3233/NRE-141049.

170

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171 Bozzetto, L., et al. (2014) A CHO/fibre diet reduces and a MUFA diet increases postprandial
172 lipaemia in type 2 diabetes: No supplementary effects of low-volume physical training. Acta
173 diabetologica, 385-93 DOI: http://dx.doi.org/10.1007/s00592-013-0522-6.

174

175 Brehmer, J.L. and J.B. Husband, Accelerated rehabilitation compared with a standard protocol
176 after distal radial fractures treated with volar open reduction and internal fixation: a
177 prospective, randomized, controlled study. J Bone Joint Surg Am, 2014. 96(19): p. 1621-30.

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178

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179 Brekke, H.K., et al. (2014) Diet and exercise interventions among overweight and obese
180 lactating women: Randomized trial of effects on cardiovascular risk factors. PLoS One, DOI:
181 http://dx.doi.org/10.1371/journal.pone.0088250.

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182

183 Britto, V.L.S., R. Correa, and M.B. Vincent (2014) Proprioceptive neuromuscular facilitation

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184 in HTLV-I-associated myelopathy/tropical spastic paraparesis. Revista da Sociedade
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185 Brasileira de Medicina Tropical, 24-9 DOI: http://dx.doi.org/10.1590/0037-8682-0245-2013.

186
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187 Brunelli, S., et al., Efficacy of progressive muscle relaxation, mental imagery, and phantom
188 exercise training on phantom limb: a randomized controlled trial. Arch Phys Med Rehabil,
189 2015. 96(2): p. 181-7.
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190
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191 Burrows, N.J., et al. (2014) Acute resistance exercise and pressure pain sensitivity in knee
192 osteoarthritis: A randomised crossover trial. Osteoarthritis and cartilage, 407-14 DOI:
193 http://dx.doi.org/10.1016/j.joca.2013.12.023.
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194
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195 Carraro, A. and E. Gobbi, Exercise intervention to reduce depressive symptoms in adults with
196 intellectual disabilities. Percept Mot Skills, 2014. 119(1): p. 1-5.
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197

198 Carter, A., et al. (2014) Pragmatic intervention for increasing self-directed exercise behaviour
199 and improving important health outcomes in people with multiple sclerosis: A randomised
200 controlled trial. Multiple sclerosis (Houndmills, Basingstoke, England), 1112-22 DOI:
201 http://dx.doi.org/10.1177/1352458513519354.

202

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203 Caruso, F.C., et al., Resistance exercise training improves heart rate variability and muscle
204 performance: a randomized controlled trial in coronary artery disease patients. Eur J Phys
205 Rehabil Med, 2014.

206

207 Cesari, M., et al., A Physical Activity Intervention to Treat the Frailty Syndrome in Older
208 Persons-Results From the LIFE-P Study. J Gerontol A Biol Sci Med Sci, 2015. 70(2): p. 216-
209 22.

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210

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211 Chen, K.M., et al., Sleep quality and depression of nursing home older adults in wheelchairs
212 after exercises. Nurs Outlook, 2014.

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213

214 Cheng, S.T., et al. (2014) Mental and physical activities delay cognitive decline in older
215 persons with dementia. American Journal of Geriatric Psychiatry, 63-74 DOI:

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216 http://dx.doi.org/10.1016/j.jagp.2013.01.060.
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217

218 Cho, H. and K.Y. Sohng, The effect of a virtual reality exercise program on physical fitness,
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219 body composition, and fatigue in hemodialysis patients. J Phys Ther Sci, 2014. 26(10): p.
220 1661-5.
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221
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222 Cho, I., et al., The effects of closed kinetic chain exercises and open kinetic chain exercises
223 using elastic bands on electromyographic activity in degenerative gonarthritis. J Phys Ther
224 Sci, 2014. 26(9): p. 1481-4.
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225

226 Cho, S.I. and D.H. An, Effects of a Fall Prevention Exercise Program on Muscle Strength and
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227 Balance of the Old-old Elderly. J Phys Ther Sci, 2014. 26(11): p. 1771-4.
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229 Choo, J., et al., Effects of weight management by exercise modes on markers of subclinical
230 atherosclerosis and cardiometabolic profile among women with abdominal obesity: a
231 randomized controlled trial. BMC Cardiovasc Disord, 2014. 14: p. 82.

232

233 Chrysohoou, C., et al., Cardiovascular effects of high-intensity interval aerobic training
234 combined with strength exercise in patients with chronic heart failure. A randomized phase III
235 clinical trial. Int J Cardiol, 2015. 179: p. 269-74.

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236

237 Chuter, V.H., et al., The efficacy of a supervised and a home-based core strengthening
238 programme in adults with poor core stability: a three-arm randomised controlled trial. Br J
239 Sports Med, 2014.

240

241 148. Coen, P.M., et al., Clinical trial demonstrates exercise following bariatric surgery

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242 improves insulin sensitivity. J Clin Invest, 2015. 125(1): p. 248-57.

243

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244 Collins, E.G., et al. (2014) Contrasting breathing retraining and helium-oxygen during
245 pulmonary rehabilitation in COPD: A randomized clinical trial. Respiratory medicine, 297-

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246 306 DOI: http://dx.doi.org/10.1016/j.rmed.2013.10.023.

247

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679 Saxton, J.M., et al. (2014) Effects of an exercise and hypocaloric healthy eating intervention
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680 on indices of psychological health status, hypothalamic-pituitary-adrenal axis regulation and

681 immune function after early-stage breast cancer: A randomised controlled trial. Breast cancer
682 research, DOI: http://dx.doi.org/10.1186/bcr3643.
D

683
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684 Sayers, S.P. and K. Gibson (2014) High-speed power training in older adults: A shift of the
685 external resistance at which peak power is produced. Journal of strength and conditioning
686 research, 616-21.
EP

687
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688 Schuch, F.B., et al., Exercise and severe major depression: Effect on symptom severity and
689 quality of life at discharge in an inpatient cohort. J Psychiatr Res, 2015. 61: p. 25-32.
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690

691 Schwenk, M., et al. (2014) Improvements in gait characteristics after intensive resistance and
692 functional training in people with dementia: a randomised controlled trial. BMC geriatrics, 73
693 DOI: http://dx.doi.org/10.1186/1471-2318-14-73.

694

695 Sharma, J., et al., Gait retraining and incidence of medial tibial stress syndrome in army
696 recruits. Med Sci Sports Exerc, 2014. 46(9): p. 1684-92.

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697

698 Shen, X. and M.K.Y. Mak (2014) Balance and gait training with augmented feedback
699 improves balance confidence in people with parkinson's disease: A randomized controlled
700 trial. Neurorehabilitation and neural repair, 524-35 DOI:
701 http://dx.doi.org/10.1177/1545968313517752.

702

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703 Shi, Z.M., et al., The effects of tai chi on the renal and cardiac functions of patients with
704 chronic kidney and cardiovascular diseases. J Phys Ther Sci, 2014. 26(11): p. 1733-6.

RI
705

706 Sillen, M.J., et al., Metabolic load during strength training or NMES in individuals with

SC
707 COPD: results from the DICES trial. BMC Pulm Med, 2014. 14: p. 146.

708

U
709 Silva Correa, C., et al. (2014) Strength training with stretch-shortening cycle exercises
710 optimizes neuromuscular economy during functional tasks in elderly women. Science and
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711 Sports, 27-33 DOI: http://dx.doi.org/10.1016/j.scispo.2013.04.005.

712
M

713 Son, S.M., M.K. Park, and N.K. Lee, Influence of Resistance Exercise Training to Strengthen
714 Muscles across Multiple Joints of the Lower Limbs on Dynamic Balance Functions of Stroke
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715 Patients. J Phys Ther Sci, 2014. 26(8): p. 1267-9.

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716

717 Souza, H., et al., Effects of inspiratory muscle training in elderly women on respiratory
718 muscle strength, diaphragm thickness and mobility. J Gerontol A Biol Sci Med Sci, 2014.
EP

719 69(12): p. 1545-53.

720
C

721 Straudi, S., et al. (2014) A task-oriented circuit training in multiple sclerosis: A feasibility
AC

722 study. BMC neurology, DOI: http://dx.doi.org/10.1186/1471-2377-14-124.

723

724 Streckmann, F., et al. (2014) Exercise program improves therapy-related side-effects and
725 quality of life in lymphoma patients undergoing therapy. Annals of Oncology, 493-499 DOI:
726 http://dx.doi.org/10.1093/annonc/mdt568.

727

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728 Sujatha, T. and A. Judie (2014) Effectiveness of a 12-week yoga program on
729 physiopsychological parameters in patients with hypertension. International Journal of
730 Pharmaceutical and Clinical Research, 329-35.

731

732 Sveaas, S.H., et al., Efficacy of high intensity exercise on disease activity and cardiovascular
733 risk in active axial spondyloarthritis: a randomized controlled pilot study. PLoS One, 2014.
734 9(9): p. e108688.

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735

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736 Taspinar, B., et al. (2014) A comparison of the effects of hatha yoga and resistance exercise
737 on mental health and well-being in sedentary adults: A pilot study. Complementary therapies
738 in medicine, 433-40 DOI: http://dx.doi.org/10.1016/j.ctim.2014.03.007.

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739

740 Taylor-Piliae, R.E., et al. (2014) Effect of tai chi on physical function, fall rates and quality of

U
741 life among older stroke survivors. Archives of physical medicine and rehabilitation, 816-24
AN
742 DOI: http://dx.doi.org/10.1016/j.apmr.2014.01.001.

743
M

744 Tibana, R.A., et al., Similar hypotensive effects of combined aerobic and resistance exercise
745 with 1 set versus 3 sets in women with metabolic syndrome. Clin Physiol Funct Imaging,
746 2014.
D

747
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748 Toth, C., et al. (2014) A randomized, single-blind, controlled, parallel assignment study of
749 exercise versus education as adjuvant in the treatment of peripheral neuropathic pain. Clinical
750 journal of pain, 111-8 DOI: http://dx.doi.org/10.1097/AJP.0b013e31828ccd0f.
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751
C

752 Ucar, M., et al., Effectiveness of a home exercise program in combination with ultrasound
753 therapy for temporomandibular joint disorders. J Phys Ther Sci, 2014. 26(12): p. 1847-9.
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754

755 van Adrichem, E.J., et al., Comparison of two preoperative inspiratory muscle training
756 programs to prevent pulmonary complications in patients undergoing esophagectomy: a
757 randomized controlled pilot study. Ann Surg Oncol, 2014. 21(7): p. 2353-60.

758

759 van het Reve, E. and E.D. de Bruin, Strength-balance supplemented with computerized
760 cognitive training to improve dual task gait and divided attention in older adults: a multicenter
761 randomized-controlled trial. BMC Geriatr, 2014. 14: p. 134.

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762

763 Vaughan, S., et al., The effects of multimodal exercise on cognitive and physical functioning
764 and brain-derived neurotrophic factor in older women: a randomised controlled trial. Age
765 Ageing, 2014. 43(5): p. 623-9.

766

767 Volpe, D., M.G. Giantin, and A. Fasano (2014) A wearable proprioceptive stabilizer

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768 (Equistasi) for rehabilitation of postural instability in Parkinson's disease: A phase II
769 randomized double-blind, double-dummy, controlled study. PLoS One, DOI:
770 http://dx.doi.org/10.1371/journal.pone.0112065.

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771

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772 Wang, Z., et al., Adapted low intensity ergometer aerobic training for early and severely
773 impaired stroke survivors: a pilot randomized controlled trial to explore its feasibility and
774 efficacy. J Phys Ther Sci, 2014. 26(9): p. 1449-54.

U
775
AN
776 Waschl, S., M.C. Morrissey, and D. Rugelj (2014) The efficacy of ultrasound-facilitated
777 electrical stimulation as an adjunct to exercise in treating chronic neck and shoulder pain.
778 Journal of musculoskeletal pain, 78-88 DOI:
M

779 http://dx.doi.org/10.3109/10582452.2014.883009.

780
D

781 Wycherley, T.P., et al. (2014) Weight loss on a structured hypocaloric diet with or without
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782 exercise improves emotional distress and quality of life in overweight and obese patients with
783 type 2 diabetes. Journal of Diabetes Investigation, 94-8 DOI:
784 http://dx.doi.org/10.1111/jdi.12120.
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785

786 Yan, H., et al. (2014) Effect of aerobic training on glucose control and blood pressure in
C

787 T2DDM East African males. ISRN Endocrinology, DOI:

788 http://dx.doi.org/10.1155/2014/864897.
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789

790 Zelber-Sagi, S., et al. (2014) Effect of resistance training on non-alcoholic fatty-liver disease a
791 randomized-clinical trial. World journal of gastroenterology, 4382-92 DOI:
792 http://dx.doi.org/10.3748/wjg.v20.i15.4382.

793

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794 Zhang, J., et al., Effects of physical exercise on health-related quality of life and blood lipids
795 in perimenopausal women: a randomized placebo-controlled trial. Menopause, 2014. 21(12):
796 p. 1269-76.

797

798 Zhuang, J., et al. (2014) The effectiveness of a combined exercise intervention on physical
799 fitness factors related to falls in community-dwelling older adul. Clinical Interventions in
800 Aging, 131-140 DOI: http://dx.doi.org/10.2147/CIA.S56682.

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801

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802

803

SC
804

805 Supplementary materials 4b: excluded published randomized controlled trials (n=13)

U
806 after random selection
AN
807

808
M

809 Reason 1: Full text available but contact unavailable (n=2)

810 Subramanian, S.S., A. Julius, and R. Hariharasudan (2014) Effects of Physioball exercises on
D

811 glycemic control and quality life of Type II diabetic patients. Biosciences Biotechnology
812 Research Asia, 325-8 DOI: http://dx.doi.org/10.13005/bbra/1275.
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813

814 Vanaky, B., H. Sadeghi, and N. Ramezani (2014) The effect of 12 weekes weight bearing
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815 water training on the bone density of middle age sedentary women. Biosciences
816 Biotechnology Research Asia, 931-6 DOI: http://dx.doi.org/10.13005/bbra/1361.
C

817
AC

818 Reason 2: Contact available but full text unavailable (n=4)

819 Durmus, D., M. Unal, and O. Kuru (2014) How effective is a modified exercise program on
820 its own or with back school in chronic low back pain? A randomized-controlled clinical trial.
821 Journal of back and musculoskeletal rehabilitation, 553-61 DOI:
822 http://dx.doi.org/10.3233/BMR-140481.

823

824 Gaeini, A.A., S. Satarifard, and A. Heidary (2014) Comparing the effect of eight weeks of
825 high-intensity interval training and moderate-intensity continuous training on physiological

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826 variables of exercise stress test in cardiac patient after coronary artery bypass graft. Journal of
827 Isfahan Medical School, 2171-81.

828

829 Mahmoodi, F. and A. Mobaraki (2014) Assessment of effects of Kegel exercises on reduction
830 of perineal pain after episiotomy in primiparous women. Iranian Journal of Obstetrics,
831 Gynecology and Infertility, 18-25.

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832

833 Park, S.Y. and I.H. Lee, Effects on training and detraining on physical function, control of

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834 diabetes and anthropometrics in type 2 diabetes; a randomized controlled trial. Physiother
835 Theory Pract, 2015. 31(2): p. 83-8.

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836

837 Reason 3 : No RCTs (n=4)

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838 Aguiar, G.C., et al., Effects of an exercise therapy protocol on inflammatory markers,
839 perception of pain, and physical performance in individuals with knee osteoarthritis.
AN
840 Rheumatol Int, 2014.

841
M

842 Bertozzi, L., et al., Effect of an exercise programme for the prevention of back and neck pain
843 in poultry slaughterhouse workers. Occup Ther Int, 2015. 22(1): p. 36-42.
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844
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845 Chang, N.W., et al., Effects of an early postoperative walking exercise programme on health
846 status in lung cancer patients recovering from lung lobectomy. J Clin Nurs, 2014. 23(23-24):
847 p. 3391-402.
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848

849 Chigira, Y., et al., Difference in the Effect of Outpatient Pulmonary Rehabilitation Due to
C

850 Variation in the Intervention Frequency: Intervention Centering on Home-based Exercise. J

AC

851 Phys Ther Sci, 2014. 26(7): p. 1041-4.

852

853 Reason 4 : Healthy subjects (n=1)

854 Fitschen, P.J., et al., Perceptual effects and efficacy of intermittent or continuous blood flow
855 restriction resistance training. Clin Physiol Funct Imaging, 2014. 34(5): p. 356-63.

856

857 Reason 5 : No active exercice program (n=2)

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858 Amorim, C.S., et al., Effectiveness of global postural reeducation compared to segmental
859 exercises on function, pain, and quality of life of patients with scapular dyskinesis associated
860 with neck pain: a preliminary clinical trial. J Manipulative Physiol Ther, 2014. 37(6): p. 441-
861 7.

862

863 Shimodozono, M., et al. (2014) Repetitive facilitative exercise under continuous electrical
864 stimulation for severe arm impairment after sub-acute stroke: a randomized controlled pilot

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865 study. Brain injury, 203-10 DOI: 10.3109/02699052.2013.860472.

866

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867

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