6.

` Brief resume of the intended work:

6.1 Need for the study:

The pleural space normally contains less than 20ml of fluid. Pleural effusion occurs when there is

excess fluid in the pleural cavity, caused by disturbed osmotic or hydrostatic pressure in the

plasma, or changes in membrane permeability.1

A pleural effusion may be transudative or exudative. A transudate develops when fluid from the

pulmonary capillaries moves into the pleural space. The fluid is thin & watery, containing a few

blood cells & little protein. The pleural surfaces are not involved in producing the transudate. In

contrast, an exudate develops when the pleural surfaces are diseased. The fluid has a high protein

content & a great deal of cellular debris. Exudates is usually caused by inflammation, infection or

malignancy.2

The common transudative causes of pleural effusion are left ventricular failure, cirrhotic liver

disease, peritoneal dialysis, hypoalbuminaemia, nephrotic syndrome, pulmonary embolism,

hypothyroidism & mitral stenosis & the common exudative causes are parapneumonic effusions,

malignant neoplasm, pulmonary embolism, rheumatoid arthritis, pancreatitis, autoimmune

diseases etc.3

The clinical features of pleural effusion are increased respiratory rate, increased heart rate, cardiac

output and blood pressure, chest pain, cyanosis & cough (productive or non-productive). The

physical signs include reduced chest wall movement on the affected side, stony dullness on

percussion, & reduced or absent breath sounds & vocal resonance. Large effusions cause

displacement of the trachea & mediastinum to the opposite side. 2, 4 In a recent study by Kalantri et

al 10 in 278 patients (of whom 57% had pleural effusions) asymmetric chest expansion had a

sensitivity of 74% and a specificity of 91%. Furthermore, when the pretest probability of disease

based on other clinical findings was applied, symmetrical chest expansion was associated with a

very low probability (8%) of pleural effusion.5

The management of each patient with a pleural effusion must be individualized. An etiologic

1
diagnosis is necessary for the appropriate treatment of the patient. The medical management

would include oxygen therapy protocol, hyperinflation therapy protocol & mechanical ventilation

protocol. The surgical management includes pleurodesis & pleuroperitoneal shunt.2, 6

The physiotherapy management of pleural effusion would include breathing exercises, localized

expansion exercises, belt exercises, positioning etc.7, 8

Milojevic et al (2003) conducted a study & concluded that patients

with pleurisy undergoing laser stimulation presented with faster resorption of effusion and

remission of the subjective symptoms, as well as significant decrease of biochemical acute

inflammation parameters in the peripheral blood and therefore with faster recovery. In patients

with pleurisy laser treatment increases regenerative mechanisms of the pleural surface, thus

decreasing the quantity of formed adhesions and resulting in better mobility of the diaphragm.9

Milojevic et al (2004) conducted a study & concluded that the applied physical therapy

(breathing exercises & laser biostimulation) resulted in significant improvement of all examined

lung function parameters & significant improvement of the diaphragm mobility It is finally

concluded that physical treatment should necessarily be included in the treatment of

exudative pleurisy.10 Polastri et al( 2012) conducted a study & concluded that the use of EzPAP

allowed lung expansion and mucus clearance.11

Chest mobilization exercises combine active movements of the trunk or extremities with deep

breathing designed to improve the mobility of the chest wall, trunk, & shoulder girdle. They are

used to reinforce or emphasize the depth of inspiration or controlled expiration. The specific

techniques in chest mobilization exercises include- to mobilize one side of the chest, to mobilize

the upper chest & stretch the pectoralis muscles & to mobilize the upper chest & shoulders. 12

Vikram et al( 2012) conducted a study & concluded that chest wall stretching exercise establishes

a betterment of respiratory functions such as reduction in dyspnea level and improvement in chest

expansion when implementing a specific stretching protocolin complications like secretion

retention & pleural effusion following a percutaneous pig tail nephrostomy.13

Incentive spirometry, also referred to as sustained maximal inspiration (SMI), is a component of

2
bronchial hygiene therapy. It is designed to mimic natural sighing or yawning by encouraging the

patient to take long, slow, deep breaths. The objectives of this procedure are to increase trans-

pulmonary pressure and inspiratory volumes, improve inspiratory muscle performance and re-

establish or stimulate the normal pattern of pulmonary hyperinflation. 14 Agostini et al (2009)

conducted a study & concluded that physiological evidence suggests

that incentive spirometry may be appropriate for lung re-expansion following major thoracic

surgery.15 Ferreira et al(2010) conducted a study & concluded that patients that were submitted to

incentive spirometry present reduction of dyspnea and lower effort sensation after the 6-MWT,

and also a better quality of life 18 months after CABG.16

Breath Stacking (BS) is a technique used to help prevent lung and chest wall stiffness and to keep

the lungs clear of secretions. The benefits of breath stacking are- keep the lungs clear of infection,

keep the air sacs open in your lungs, keep the chest wall flexible which allows you to take bigger

breaths on your own, keep the lungs clear of mucous plugs & improve one’s ability to cough. 17

Dias et al (2008) conducted a study & concluded that the breath stacking technique was shown to

be effective. This technique was better than incentive spirometry for generating and sustaining

have been described, this technique can probably be used safely and effectively, particularly in

uncooperative patients.17 Baker et al (1990) conducted a study & concluded that when compared

with IC, "breath stacking" (valved) maneuvers increased inspired volume by an average of 15 to

20% (p less than 0.05). More importantly, there was a several fold increase in the time over which

high lung volume was sustained (p less than 0.001).19 Larissa et al (2012) conducted a study &

concluded that data from both the intra-examiner and inter-examiner analyses suggest that the BS

technique is reproducible. This technique mobilizes greater lung volumes than conventional

spirometry.20 Stacked breathing is an entirely new & similar concept in which an individual

breathes in 3-4 times without expiration, each time filling the lung a little bit more up to VC. This

technique is a very effective way for an individual with weak respiratory muscles to achieve a full

inspiration prior to a cough. The glottis closes between each attempt allowing for a build up of

volume within the lungs.21

3
Chest mobility exercises are effective in improving the mobility of the chest wall, trunk,

shoulders, increasing ventilation on that side of the chest, emphasizing depth of inspiration &

controlling expiration. These exercises are effective in improving the chest expansion in subjects

with pleural effusion. Study done by Vikram M et al (2012) concludes that chest mobility

exercises have resulted in betterment of respiratory functions such as reduction in dyspnea level

& significant improvement in chest expansion when implementing a specific stretching protocol

in complications such as secretion retention & pleural effusion following a percutaneous pig tail

nephrostomy.16 Incentive spirometry has been found to be appropriate for lung re-

expansion following major thoracic surgery19 but it is not known whether Incentive spirometry

can produce similar kind of re-expansion in subjects with unilateral pleural effusion. Also, the

Breath stacking technique has shown to be effective particularly in uncooperative patients

following abdominal surgeries15 & in mobilizing greater lung volumes17 & in achieving and

sustaining deep inspiration, even in uncoached patients. 13 But it is not known whether it will have

similar effects in patients with unilateral pleural effusion. Therefore, there exists a need to

compare the effectiveness of chest mobility exercises with incentive spirometry & chest mobility

exercises with stacked breathing on the chest expansion in patients with unilateral pleural

effusion.

Hypothesis:

There will be no significant difference between the effectiveness of chest mobility exercises with

incentive spirometry & chest mobility exercises with stacked breathing on chest expansion in

subjects with unilateral pleural effusion.

6.2 Review of Literature:

Review on Pleural Effusion:

M. Polastri et al (2012) conducted a case study to describe the postoperative treatment of a left

pleural effusion that occurred in a patient who had undergone aortic surgery & forty eight hours

4
postoperatively, a left pleural effusion was observed. Pulmonary CT confirmed almost complete

atelectasis of the left lung resulting from secretions and pleural effusion. The EzPAP with a

mouthpiece was used with the patient sitting & the session included breathing exercises and

manual chest therapy, lasted 30 minutes and was repeated twice in the afternoon on the first day

of admittance to the cardiac ward. During the second session on the same day, the patient was

encouraged to cough & a large amount of mucus was expectorated at one time. A marked

difference was observed in the imaging studies: those obtained on the third day showed a decrease

in the opacity of the left lung, which was completely white on admission. At follow-up 56 days

later, total resolution was observed. The author concluded the use of EzPAP allowed lung

expansion and mucus clearance using only one instrument.11

Dipali P Rana et al (2012) conducted a study to identify the effect of positioning on pulmonary

functions in Unilateral Pleural Effusion. Randomly selected 25 subjects, irrespective of sex, of the

age group 20-50 years with unilateral pleural effusion were included in the study & it was

concluded that the FVC, FEV1 and FEV1/FVC values between the three different positions

showed no significant difference (p>0.10) although the mean values of FVC in sitting position

was higher than mean value of FVC in lateral positions.22

Enrique Dias-Guzman et al (2008) conducted a study to compare the sensitivity & specificity of

different physical signs of pleural effusion to those of conventional chest radiography &

concluded that in 278 patients (of whom 57% had pleural effusions), asymmetric chest expansion

had a sensitivity of 74% and a specificity of 91%. Furthermore, when the pretest probability of

disease based on other clinical findings was applied, symmetrical chest expansion was associated

with a very low probability (8%) of pleural effusion.5

Hulzebos EH et al (2007) conducted a study which aimed to evaluate the prophylactic efficacy

of preoperative physiotherapy, including inspiratory muscle training (IMT), on the incidence of

postoperative pulmonary complications (PPCs) in high-risk patients scheduled for elective

coronary artery bypass grafting (CABG). A total of 279 were enrolled and monitored up to

discharge from hospital. Patients were randomly assigned to receive either preoperative IMT

5
(n=140) or usual care (n=139). Both groups received the same postoperative treatment. The

author concluded that preoperative physiotherapy, including IMT, statistically significantly

reduced the incidence of PPCs and the duration of post operative hospitalization in patients at

high risk of developing a pulmonary complication on undergoing CABG.23

Milojević M et al (2004) conducted a study which aimed to find out the following: 1) Is lung

function improved by physical therapy; 2) Can adhesions be diminished and mobility of the

affected hemidiaphragm improved by physical treatment. Physical treatment consisted of directed

breathing exercises and laser biostimulation. The author concluded that the applied

physical therapy resulted in: 1) significant improvement of all examined lung function parameters

in the examined group, which was not registered in the control group; 2) significant improvement

of the diaphragm mobility in general. It is finally concluded that physical treatment should

necessarily be included in the treatment of exudative pleurisy.10

Milojević M et al (2003) conducted a study on effects of laser biostimulation on patients

with pleurisy. The analysis included 25 patients & apart from conservative treatment, these

patients were treated with laser biostimulation of acupuncture points and local region for ten

days.. The author concluded patients with pleurisy undergoing laser stimulation presented with

faster resorption of effusion and remission of the subjective symptoms, as well as significant

decrease of biochemical acute inflammation parameters in the peripheral blood and therefore with

faster recovery. In patients with pleurisy laser treatment increases regenerative mechanisms of the

pleural surface, thus decreasing the quantity of formed adhesions and resulting in better mobility

of the diaphragm.9

Review on Chest Mobility Exercises:

Vikram M et al (2012) conducted a study where chest physiotherapy was executed on a 15-year-

old girl who had complications such as secretion retention and pleural effusion following

percutaneous pigtail nephrostomy.. Chest mobility exercises composed of an intercostal stretch on

a determined intercostal space using index fingers, thoracic rotation and anterior compression

with stretching in sitting position to improve respiratory functions. Following 9th sessions of
6
treatment patient demonstrated satisfactory improvement by means of increasing in chest

expansion and reduction in dyspnea level without using supplemental oxygen. The author

concluded that there was a betterment of respiratory functions such as reduction in dyspnea level

and improvement in chest expansion when implementing a specific stretching protocol. 13

Review on Breath Stacking and Incentive Spirometry:

Larissa Andrade de Sá Feitosa1 et al (2012) conducted a study to identify the reproducibility of

the Breath stacking technique in healthy volunteers and to compare BS with conventional

spirometry with regard to inspiratory capacity. Eighty-five healthy volunteers (21.78 ± 2.79 years;

41 men, 44 women) underwent spirometry and BS. BS was performed with a unidirectional

inspiratory valve by two different examiners. Spirometric tests were performed three times, and

the BS manoeuvre was evaluated three times by each examiner. Respiratory rate, heart rate and

peripheral arterial oxygen saturation were determined before, during and following the

manoeuvre. The author concluded that data from both the intra-examiner and inter-examiner

analyses suggest that the BS technique is reproducible. This technique mobilizes greater lung

volumes than convfentional spirometry.20

Ferreira GM et al (2010) conducted a study to test if the use of incentive spirometry (IS)

associated with expiratory positive airway pressure (EPAP), after CABG surgery improves

dyspnea, effort perceived and quality of life 18 months after CABG. Sixteen patients submitted to

a CABG, were randomized to a control group (n=8) or IS+EPAP group (n=8). The protocol of

IS+EPAP was applied in the immediate postoperative period and following for more 4 weeks in

the patient's home. Eighteen months after CABG, the strength of the respiratory muscle, the

functional capacity, the lung function, the quality of life and the level of physical activity were

evaluated. The author concluded patients that were submitted to IS+EPAP present reduction of

dyspnea and lower effort sensation after the 6-MWT, and also a better quality of life 18 months

after CABG.16

Agostini P et al (2009) conducted a study to review the evidence for incentive spirometry,

examining the physiological basis, equipment and its use following thoracic surgery. Initially, 106

7
studies were found in MEDLINE, 99 in EMBASE and 42 in CINAHL. Eight references were

found in the Cochrane Library and one paper in the Chartered Society of Physiotherapy Resource

Centre. Four studies and one systematic review investigating the effects of postoperative

physiotherapy and incentive spirometry in thoracic surgery patients were selected and reviewed.

The author concluded incentive spirometry may be appropriate for lung re-

expansion following major thoracic surgery. Based on sparse literature, postoperative

physiotherapy regimes with, or without, the use of incentive spirometry appear to

be effective following thoracic surgery compared with no physiotherapy input.15

Dias CM et al (2008) conducted a study to compare the inspiratory volume during the breath

stacking maneuver with the volume during incentive spirometry, in abdominal surgery patients.

Twelve patients, on their first postoperative day, were instructed to take a deep breath through the

Voldyne™ incentive spirometer and to make successive inspiratory efforts using a facemask that

had been adapted for performing the breath stacking maneuver A Wright™ ventilometer allowed

inspiratory capacity to be recorded. The author concluded that the breath stacking technique was

shown to be effective. This technique was better than incentive spirometry for generating and

sustaining inspiratory volumes. Since no adverse effects have been described, this technique can

probably be used safely and effectively, particularly in uncooperative patients.18

Elisabeth Westerdahl et al (2001) conducted a study to identify the effectiveness of three deep

breathing techniques which was evaluated in 98 male patients after coronary artery bypass graft

surgery. The techniques examined were deep breathing with a blow bottle-device, an inspiratory

resistance-positive expiratory pressure mask (IR-PEP) and performed with no mechanical device.

Four days post-operatively there were significantly decreased vital capacity, inspiratory capacity,

forced expiratory volume in 1 second, functional residual capacity, total lung capacity and single-

breath carbon monoxide diffusing capacity in all three groups (p < 0.0001). The author concluded

that the Blow bottle group had significantly less reduction in total lung capacity (p = 0.01)

compared to the Deep breathing group, while the IR-PEP group did not significantly differ from

the other two groups.24

8
 Baker WL et al (1990) conducted a study whether using a one-way valve to prevent exhalation

would allow rest between inspiratory efforts and cause volume to cumulate during successive

tidal efforts, improving both the depth and duration of the inspiratory maneuver. 26 subjects

breathed via mouthpiece from a spirometer prefilled with 100% oxygen. Three different

maneuvers were performed in random order by all subjects: (1) standard inspiratory capacity

without valve or inspiratory hold, (2) inspiratory capacity (IC) with breath holding aided by a

one-way valve, and (3) uncoached breath-stacking, during which successive tidal breaths were

cumulated by one-way valving. A fourth maneuver was added in the last 13 subjects studied: an

initial coached IC effort with subsequent valved stacking of tidal efforts. The author concluded

that when compared with IC, "breath stacking" (valved) maneuvers increased inspired volume by

an average of 15 to 20% (p less than 0.05). More importantly, there was a several fold increase in

the time over which high lung volume was sustained (p less than 0.001).The results indicate that

one-way valving helps to achieve and sustain deep inspiration, even in uncoached patients.19

6.3 Objectives of the study:

1. To determine the efficacy of chest mobility exercises & incentive spirometry on chest

expansion in subjects with unilateral pleural effusion.

2. To determine the efficacy of chest mobility exercises & stacked breathing on chest expansion in

subjects with unilateral pleural effusion.

3. To compare the efficacy of chest mobility exercises & incentive spirometry with that of chest

mobility exercises & stacked breathing on chest expansion in subjects with unilateral pleural

effusion.
7. Materials and Methods:

7.1 Source of Data:

 ESI Hospital, Rajajinagar, Bangalore.

 K C General Hospital, Malleshwaram, Bangalore.

9
7.2 Method of collection of data:

 Population : Subjects with Pleural effusion.

 Sampling : Convenience sampling.

 Sample size : 30.

 Type of Study : Experimental study with pre post test design.

 Duration of the study : 6 months.

Inclusion Criteria:

 Subjects with Unilateral Pleural Effusion.

 Age – 20-50 years.

 Subjects of both genders.

 Subjects diagnosed as pleural effusion by the physician.

 Subjects with asymmetrical chest expansion.

Exclusion Criteria:

 Orthopaedic conditions.

 Hypertension.

 Pleural effusion due to transudate conditions like: liver cirrhosis, CCF etc.

 Malignant conditions.

 Cognitive impairments.

 Refusals.

Material used:

 Couch.

 Paper.

 Pen.

 Incentive spirometer.

10
  Measuring tape.

Measuring tools:

Thoracic flow cytometry

Methodology

Intervention to be conducted on the participants:

After getting ethical clearance subjects will be enrolled in the study. Patients with unilateral

pleural effusion will be recruited from the medical ward of the hospital. Subjects will be selected

based on the inclusion and exclusion criteria. Following an initial assessment the patients will be

assigned to one of the two groups by block randomization.

After randomizing the patient to one of two groups, before the intervention chest expansion will

be measured by Thoracic flow cytometry according to Kakizaki et al. 25 Basal expansions was

determined by using a tape measure as it is known that pleural effusion accumulates in the lower

zones. Each measurement was obtained after maximal expiration followed by maximum

inspiration and another maximal expiration. Measurements were taken twice and the mean of the

two values was recorded.

Group A will receive Chest mobility exercises with Incentive spirometry according to Kisner 9 &

the AARC guideleines.14

Group B will receive Chest mobility exercises with Stacked breathing according to Kisner 9 &

breath stacking technique explained by Providence Care.17

Both groups will be instructed to perform the intervention 3 times per day, 7-8 times per session

for one week.

Thoracic flow cytometry will be repeated after one week.

11
Outcome measures:

Chest expansion.

Statistics:

 Data analysis will be performed by SPSS (version 17) for windows. Alpha value will be

set as 0.05.

 Descriptive statistics will be used to find out mean, standard deviation & range for

demographic and outcome variable.

 Unpaired t test will be used to find out the homogeneity for baseline & demographic &

outcome variable.

 Chi square test will be used to find out gender differences among the two groups.

 Paired t test will be used to find out significant differences for the chest expansion within

the groups.

 Unpaired t test will be used to find out significant differences for the chest expansion

between the groups.

 Microsoft word, excel will be used to generate graph and tables etc.

7.3 Does the study require any investigation or intervention to be conducted on patients or

other humans or animals? If so please describe briefly.

Yes, the study will be carried out on human subjects of both genders with the age group of 20-50

years having unilateral pleural effusion with reduced chest expansion, to compare the

effectiveness of chest mobility exercises and incentive spirometry versus chest mobility exercises

and stacked breathing.

7.4 Has the ethical clearance been obtained from your institution in case of 7.3.
12
 Yes, ethical clearance has been obtained from the institution. As this study will involve human

subjects, the ethical clearance has been obtained from the ethical committee of Padmashree

institute of physiotherapy, Nagarbhavi, Bangalore, as per ethical guidelines research from

biomedical research on human subjects, 2000, ICMR, New Delhi.

List of References:
1. Hough A. Physiotherapy in Respiratory Care.3rd ed.2001.p.98.
8. 2. Jardins TD, Burton GG. Clinical Manifestations and Assessment of Respiratory Disease.

5th ed. p.319-323.

3. McGrath EE, Anderson PB. Diagnosis of Pleural Effusion: A systematic approach.

American Journal of Critical Care.2011 Mar;20(2).

4. Colledge NR, Walker BR, Ralston SH. Davidson’s Principles and Practice of

Medicine.19th ed.2002.p.501-3.
5. Guzman ED, Budev MM. Accuracy of the physical examination in evaluating pleural

effusion. Cleveland Clinic Journal of Medicine 2008 Apr;75(4).

6. Scanlan CL, Wilkins RL, Stoller JK. Egan’s Fundamentals of Respiratory Care.7 th

ed.1999.p.477-83
7. Downie PA. Cash’s Textbook of Chest, Heart & Vascular Disorders for Physiotherapists.

4th ed.1987.p.533
8. W. Darlene Reid & Frank Chung. Cardiopulmonary Physical Therapy.2004.p.130
9. Milojević M, Kuruc V. Laser biostimulation in the treatment of pleurisy. 2003 Nov-
Dec;56(11-12):516-20
10. Milojević M, Kuruc V. The role of physical rehabilitation in the treatment of

exudative pleurisy. 2004 Jan-Feb;57(1-2):13-7.

11. M. Polastri, A. Pantaleo. Managing a left pleural effusion after aortic surgery; European

Review for Medical and Pharmacological Sciences. 2012;16(4 Suppl):78-80

12. Carolyn Kisner & Lynn Allen Colby. Therapeutic Exercise. 5th ed.2007.p.867

13. Vikram M , Leonard JH, Kamaria K. Chest Wall Stretching Exercise as an Adjunct

Modality in Post Operative Pulmonary Management.2012 Mar 4.

14. AARC Clinical Practice Guideline; Reprinted from the December 1991 issue of

Respiratory Care [Respir Care 1991;36(12):1402–1405].

15. Agostini P, Singh S. Incentive spirometry following thoracic surgery: what should we be

13
 doing? 2009 Jun; 95(2):76-82. Epub 2009 Mar 3.
16. Ferreira GM, Haeffner MP, Barreto SS, Dall'Ago P. Incentive spirometry with expiratory

positive airway pressure brings benefits after myocardial revascularization. 2010 Feb;

94(2):230-5, 246-51, 233-8.

17. Providence Care available from URL

http://www.providencecare.ca/obkects/content_revision/download.cfm/revision_id-

4/Breath%20 Stacking%20handbook.pdf/2008;1-11
18. Dias CM, Plácido TR, Ferreira MFB, Guimarães FS, Menezes SLS. Incentive spirometry

and breath stacking: effects on the inspiratory capacity of individuals submitted to

abdominal surgery; Rev Bras Fisioter. 2008; 12(2):94-9.

19. Baker WL, Lamb VJ, Marini JJ. Breath-stacking increases the depth and duration of chest

expansion by incentive spirometry. 1990 Feb; 141(2):343-6.

20. Feitosa LAS, Barbosa PA, Pessoa MF, Rodrigues-Machado MG, Andrade AD.

Clinimetric Properties of Breath-stacking Technique for Assessment of Inspiratory

Capacity; Physiother. Res. Int. 17 (2012) 48–54 2011 John Wiley & Sons, Ltd
21. Moyna J. Parker .Breathing techniques. Physiotherapy in Thoracic Condition. p.213
22. Rana DP, Talati N. Effect of Positioning on Pulmonary Functions in Unilateral pleural

effusion. 2012 Apr.

23. Hulzebos EH, Helders PJ, Favié NJ, de Bie RA, Brutel de la Rivière A, van Meeteren

NL(2007).
24. Westerdahl E, Lindmark B, Almgren SO, Tenling A. Chest Physiotherapy After Coronary
Artery Bypass Graft Surgery—A Comparison of Three Different Deep Breathing

techniques. J Rehab Med 2001;33: 79–84

25. Kakizaki F ,Shibuya M ,Yamazaki T, Yamada M,Suzuki H ,Homma I. Preliminary report

on the effects of respiratory muscle stretch gymnastics on chest wall mobility in patients

with COPD. Respir Care 1999; 44:409-14.

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