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DISSERTATION SYNOPSIS SUBMITTED TO RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE

TOWARD PARTIAL FULFILMENT OF MASTER OF PHYSIOTHERAPY DEGREE COURSE BY

NITHINCHANDRA N. KINI

UNDER THE GUIDANCE OF VARADHARAJ P

VIKAS COLLEGE OF PHYSIOTHERAPY AIRPORT ROAD, MARRY HILL, KONCHADY, MANGALORE-575008 2010-11

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the NITHINCHANDRA N. KINI candidate and VIKAS COLLEGE OF PHYSIOTHERAPY, address AIRPORT ROAD, MARY HILL KONCHADY POST, MANGALORE-575008

2. Name of the VIKAS COLLEGE OF PHYSIOTHERAPY. Institution MANGALORE

3. Course of study and Master of Physiotherapy subject Physiotherapy in Community Based Rehabilitation

4. Date of admission to Course 08/03/2010

5. Title of the Topic The effects of a community-based pulmonary rehabilitation programme on COPD patient to improve the exercise tolerance and quality of life: a randomized controlled trial

6. Brief resume of intended work: 6.1 Need for the study

Chronic obstructive pulmonary disease (COPD) is the most common chronic pulmonary disorder, affecting 10 to 15 percent of adults over the age of 55, and its prevalence is increasing.1 COPD is a disorder characterized by the presence of airflow obstruction that is generally progressive, may be accompanied by airway hyper reactivity, and may be partially reversible.2 The pulmonary components that comprise COPD are chronic bronchitis and emphysema. In the majority of the cases chronic bronchitis is a major cause of obstruction but in some cases emphysema is predominant. Thus there are two pattern s of chronic obstructive airway disease which can be distinguished clinically although the majority of patients shows mixer of both. In one pattern the patient is blue and bloated whereas in the other the patient is pink and puffing.3

According to the American Thoracic Society, Chronic bronchitis is defined as chronic cough and expectoration, when other specific cause of cough can be excluded, which persist for at least a three months period for at least 2 consecutive years.4 Emphysema is defined as abnormal enlargement of the distal respiratory unit accompanied by destructive changes of the alveolar walls without obvious fibrosis.2,4 Over distension of the air space without destruction of the alveolar wall, as normally seen in aging, is not included in the definition of emphysema. Because chronic bronchitis and emphysema can coexist and their clinical signs and symptoms overlap, the term COPD is useful in the clinical setting to describe the combination of these disorders.

Patients with COPD presents with symptoms of chronic cough, expectoration and exertional dyspnea. It has been well documented that dyspnea is associated with anxiety and fear.3, 7, 9 Dyspnea occur at progressively lower activity levels. Severely involved patients may appear dyspneic even at rest.5 The intensity of each symptom varies according to the patient’s unique combination of individual diseases. As the diseases progress, symptoms worsen. Respiratory infections are common. These all together make the patients disabled. Patients who suffer dyspnea report significant limitation during daily life and reduction in exercise tolerance. One study has reported that high level of disability in patients with COPD, with 50% of patients studied requiring assistance with household chores.7, 8, 10 Almost all the patients investigated reported some degree of breathlessness during washing and dressing. Exercise limitation may be attributable to both the illness itself and to pre-existing levels of cardio vascular fitness. Further more physical deconditioning substantially contributes to reduction in mobility with 60% of patients with COPD citing leg fatigue as a factor limiting walking distance.4,13,14

The main goal in treating COPD patients is to decrease dyspnea, improve quality of life, exercise tolerance, improve muscle endurance and strength in respiratory and peripheral muscles, improve lung condition, and allow the patient to resume their normal activities. Pulmonary rehabilitation is popular among physiotherapists as a management approach for COPD patients to improve lung condition, improve exercise tolerance and quality of life. Pulmonary rehabilitation is usually carried out in institutional setting and mostly caters to the urban population. For the vast majority of rural population suffering from COPD pulmonary rehabilitation is usually not accessible due to either lack of facilities or economical reasons. At present the efficacy of Community based pulmonary rehabilitation on COPD patients to improve exercise tolerance and quality of life is unclear. Very few clinical trials have been done to assess the efficacy of Community based pulmonary rehabilitation on COPD patients to improve exercise tolerance and quality of life, with varied out comes.12, 13

Though pulmonary rehabilitation proved their efficacy on COPD patients, there are less studies presently available on efficacy of Community based pulmonary rehabilitation on COPD patients. Therefore this study is intended to see the effectiveness of Community based pulmonary rehabilitation on COPD patients to improve exercise tolerance and quality of life.17, 18, 19

6.2 Review of literature

1. Cambach W, Kemper HC et al conducted a 3 month multicentre study to evaluate the effects of a community-based pulmonary rehabilitation programme on exercise tolerance and quality of life in patients with asthma and chronic obstructive pulmonary disease (COPD). The programme included exercise training, patient education, breathing retraining, evacuation of mucus, relaxation techniques, and recreational activities. After 3 months, the patients who started with rehabilitation showed significant improvements in endurance time, exercise tolerance and quality of life and total CRDQ score compared to the control group and the improvements were still significant after 6 months. Additional analysis indicated that the asthmatic patients and the patients with COPD responded to rehabilitation in a similar way. They concluded that CBR in patients with asthma or chronic obstructive pulmonary disease improves exercise tolerance and quality of life.10

2. Wetering Van C R, Hoogendoorn M et al conducted a 2 year randomised controlled trial on short- and long-term efficacy of a community-based COPD management programme in less advanced COPD. Intervention consisted of 4 months multidisciplinary rehabilitation followed by a 20-month maintenance phase. The study showed that a multidisciplinary community-based disease management programme is effective in improving exercise impairment in COPD patients with less advanced airflow obstruction.11

3. Hernandez MTE, Rubio TM et al conducted a 12 week study on the efficacy of Home-Based Walking Training Program in 60 patients with COPD at an intensity of 70% of the maximum speed attained on the SWT. Results showed no changes in pulmonary function or effort parameters in the rehabilitation group but a twofold increase in the submaximal intensity resistance test, with significant improvement dyspnea and in the quality of life. They concluded that a simple home-based program of exercise training achieved improvement in exercise tolerance, post effort dyspnea, basal dyspnea, and quality of life in COPD patients.12

4. Puhan MA, Troosters MST et al conducted a systematic review of on the effect of respiratory rehabilitation after acute exacerbation of COPD in reducing risk for readmission, mortality and improvement in the quality of life.. Results showed that respiratory rehabilitation reduced the risk for hospital admissions and mortality and improved exercise capacity in all trials. They conclude that respiratory rehabilitation is effective in COPD patients after acute exacerbation but larger trials, however, are needed to further investigate the role of respiratory rehabilitation after acute exacerbation and its potential to reduce costs caused by COPD. 13

5. Ward JA, Ward DG, Akers Gill et al conducted a study on thirty-four patients with COPD to determine the feasibility and effectiveness of a pulmonary rehabilitation programme in a community hospital setting. Results showed a significant improvement in the walking distance, and in all domains of the CRQ.14

6. Bendstrup KE, Jensen JI et al conducted a RCT to find out the efficacy of a 12 week pulmonary rehabilitation programme consisting of physical training, occupational therapy, education, and smoking cessation therapy in improving the activities of daily living, quality of life and exercise tolerance in chronic obstructive pulmonary disease. Results showed significant differences in the improvements in ADL and CRDQ between the control and the treatment groups at 12 and 24 weeks, and at 24 weeks. They concluded that An inexpensive, comprehensive out-patient rehabilitation programme can produce long-term improvement in activities of daily living, quality of life, and exercise tolerance in patients with moderate-to-severe chronic obstructive pulmonary disease.15

7. Maltais F, Bourbeau J et al in a 4 week randomized trial following a 4 week education programme compared the effects of Home-Based Pulmonary Rehabilitation with hospital based rehabilitation programme in Patients with Chronic Obstructive Pulmonary Disease. The results showed that both interventions produced similar improvements in the Chronic Respiratory Questionnaire dyspnea subscale and the difference between the 2 treatments at 1 year was small and clinically unimportant. They concluded that Home rehabilitation is a useful, equivalent alternative to outpatient rehabilitation in patients with COPD.16

8. Bestall et al in a study examined the validity of the Medical Research Council (MRC) dyspnea scale as a simple and standardized method of categorising disability in COPD. Results showed that there was a significant association between MRC grade and shuttle distance, SGRQ and CRQ scores, mood state and EADL. They concluded that MRC dyspnea scale is a simple and valid method of categorizing patients with COPD in terms of their disability that could be used to complement FEV1 in the classification of COPD severity.17 9. Enright PL et al conducted a study on the 6 minute walk test: a quick measure of functional status in elderly adults and concluded that 6MWT is a useful measure of functional capacity, targeted at people with at least moderately severe impairment. It has been widely used for measuring the response to therapeutic interventions for pulmonary and cardiac disease.18

10. Schunemann HJ et al developed a standardized chronic respiratory questionnaire (CRQ), a widely used measure of health-related quality of life (HRQL) in patients with chronic airflow limitation, as the chronic respiratory questionnaire includes an individualized dyspnea domain which is unwieldy in multicenter clinical trials. They further tested its discriminative and evaluative properties by comparing the standardized and individualized CRQ before and after a 3 month respiratory rehabilitation program. They calculated both cross-sectional and longitudinal correlations between the two versions and a number of other HRQL instruments, and tested the relative ability of the individualized and standardized versions of the CRQ to detect improvement with rehabilitation and they concluded that standardized version of the CRQ dyspnea domain improves the cross-sectional validity, maintains longitudinal validity, but reduces the responsiveness.19

6.3 Objectives of the study

The objective the study is to determine the efficacy of a community based pulmonary rehabilitation programme in reducing dyspnea, and improving exercise tolerance test and quality of life. 7 MATERIALS AND METHODS . 7.1 Source of data

Data will be collected from rural patients living around Mangalore with diagnosis of COPD and referred for physical therapy, after obtaining informed consent.

7.2 Method of collection of data

Hypothesis

Community based pulmonary rehabilitation programme is effective in reducing dyspnea and improving exercise tolerance test and quality of life in rural patients with COPD.

Null Hypothesis

Community based pulmonary rehabilitation programme is not effective in reducing dyspnea and improving exercise tolerance test and quality of life in rural patients with COPD.

Research Design

Single factor experimental design will be used for this study.

Sampling method

Random sampling method

METHODOLOGY

Patients with complaints of dyspnea, who are diagnosed to have COPD, will be randomly assigned to one of two groups. Each group will consist of 15 patients and will include both male and female patients within the age group of 40-60 years. To be eligible for the study the subjects should fulfill the following inclusion and exclusion criteria. Inclusion Criteria

1. A clinical diagnosis of stable COPD, as defined by American Thoracic Society Criteria

2. No history of Asthma

3. No exacerbation of COPD in the 2 months prior to recruitment

4. No acute chest infection or surgery within the last 2 months

5. Aged 40-60 years of both gender

6. Baseline pre-bronchodilator FEV1 of 25-80% predicted

7. Reversibility of FEV1 post-inhalation of bronchodilator

8. Pre-bronchodilator ratio FEV1/inspiratory vital capacity ≤ 60%

9. TLC greater than TLC predicted

10. Use of nasal corticosteroids, theophyllines, acetylcysteine and all other bronchodilators was allowed

11. Walk independently without aids

Exclusion criteria

1. Current smoker

2. Maintenance treatment of oral steroids or antibiotics

3. Interstitial lung disease

4. Lung cancer

5. Other active lung disease

6. Neuromuscular disorders

7. Spinal deformities

8. Cardiac insufficiency and disorders

9. Psychiatric Morbidity like alcoholism

10. Endocrine disorders 11. Metabolic disorders

12. Active gastrointestinal problems

13. Patients on supplemental oxygen

Interventions

One group, which is an experimental group, will be under go community based pulmonary rehabilitation, and the other group which is a control group will be asked to continue with standard medical treatment and education as prescribed by their physician. Both groups will undergo training for 8 weeks.

Group 1: This group will consist of 15 subjects (N=15) of both gender and they will be undergo community based pulmonary rehabilitation programme.

The group will undergo the following treatment: 1. Relaxation positions 2. Relaxed diaphragmatic breathing exercise with pursed lip breathing 3. General relaxation technique 4. Inspiratory muscle training 5. Home postural drainage 6. Self or care giver administered chest manipulations 7. Effective coughing or huffing techniques 8. Graduated walking programme 9. Health education to prevent recurrence of COPD

Group 2: This group will consist of 15 subjects (N=15) of both gender and they will under go standard medical care as prescribed by a physician along with health education to prevent recurrence of COPD

Evaluation

Before the beginning of the study the subjects’ pre and post-bronchodilator lung volumes and capacities are measured using spirometry to evaluate the FEV1, ratio of FEV1/ inspiratory vital capacity and Total Lung Capacity to find out their eligibility for the study.

Outcome measures

Further, before the beginning of the study and after 8 weeks of training all patients will be evaluated in the following outcome measures. 1. The MRC dyspnea scale to measure disability

The MRC dyspnoea scale is a questionnaire that consists of five statements about perceived breathlessness:

Grade 1: I only get breathless with strenuous exercise

Grade 2: I get short of breath when hurrying on the level or up a slight hill

Grade 3: I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level

Grade 4: I stop for breath after walking 100 yards or after a few minutes on the level

Grade 5: I am too breathless to leave the house

2. Six minute walking distance test to measure functional capacity

The 6MWT is a useful measure of functional capacity, targeted at people with at least moderately severe impairment. It has been widely used for measuring the response to therapeutic interventions for pulmonary and cardiac disease.

3. Standardized Chronic Respiratory Questionnaire (CRQ)

The standardized chronic respiratory questionnaire (CRQ) is a widely used measure of health-related quality of life (HRQL) in patients with chronic airflow limitation, and includes an individualized dyspnea domain (patients identify five important activities, and report the degree of dyspnea on a 7-point scale).

1. Extremely short of breath 2. Very short of breath 3. Quite a bit short of breath 4. Moderate shortness of breath 5. Some shortness of breath 6. A little shortness of breath 7. Not at all short of breath Not done

The patient is asked to describe how much shortness of breath he has experienced during the last 2 weeks while doing the five most important activities he has selected. They are instructed to indicate how much shortness of breath the person had, during the last 2 weeks while performing one of the following options from the card in front of them.

List of activities 1. Feeling emotional such as angry or upset 2. Taking care of your basic needs (bathing, showering, eating, or dressing) 3. Walking 4. Performing chores (such as housework, shopping, groceries) 5. Participating in social activities

7.3 Statistical Analysis

The data collected will be analyzed using parametric tests as the data are interval in nature. The intra group pre and post-test data will be analyzed using paired t-test, while the post-test inter group data will be analyzed with unpaired t-test.

7.4 The study requires non-invasive investigations and interventions to be conducted on patients. The investigations to be conducted include physical examination of the Lungs like inspection, palpation, percussion, auscultation, Six minute walk distance test and Lung function tests using Spirometry. Treatment interventions include Relaxation positions, Relaxed diaphragmatic breathing exercise with pursed pursed lip breathing, General relaxation technique, Inspiratory muscle training, Home postural drainage, Self or care giver administered chest manipulations, Effective coughing or huffing techniques and Graduated walking programme. 8. List of Reference

1. American Thoracic Society: Standards for the diagnosis and care of patients with chronic obstructive pulmonary diseases (COPD) and asthma, Am J Respiratory Critical Care Med, 1995, 152, 77 2. American Thoracic Society: Standards for the diagnosis and care of patients with chronic obstructive pulmonary diseases (COPD) and asthma. Am Rev Respiratory Di, 1987, 136, 225. 3. Jennifer A Pryor, Physiotherapy for Respiratory and Cardiac Problems, 2007, 524. 4. Ann Thomson, Tidy’s Physiotherapy, 2002, 185, Twelfth edition. 5. Susan O’Sullivan, Physical Rehabilitation: Assessment and Treatment, 2001, 449, Fourth Edition. 6. Andrew L. Ries et al Pulmonary rehabilitation: Joint ACCP/AACVPR evidence based guideline, 1997, 112. 7. Aman Pande et al Effect of Home-based Pulmonary Rehabilitation Programme on Disability in Patients with Chronic Obstructive Pulmonary Disease, 2005; 47, 217-219. 8. P. C. Das, Text Book Of Medicine, 1992, 144. 9. T Bhaskara Rao, Text Book Of Community Medicine by Saunders Manual of Physical Therapy Practice, 2008-09. 10. Cambach W et al The effects of a community-based pulmonary rehabilitation programme on exercise tolerance and quality of life: a randomized controlled trial, 1997, 164. 11. Wetering CRV et al Short- and long-term efficacy of a community-based COPD management programme in less advanced COPD: a randomised controlled trial, Thorax 2010, 65, 7-13. 12. Hernandez MTE et al Results of a Home-Based Training Program for Patients with COPD, 2000, 116. 13. Puhan MA et al Respiratory rehabilitation after acute exacerbation of COPD may reduce risk for readmission and mortality – a systematic review, 2005, 106. 14. Ward JA et al Feasibility and effectiveness of a pulmonary rehabilitation programme in a community hospital setting, 2002, 52, 539-542. 15. Bendstrup KE et al Out-patient rehabilitation improves activities of daily living, quality of life and exercise tolerance in chronic obstructive pulmonary Disease, 1989, 23-43. 16. Maltais F et al Effects of Home-Based Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease a Randomized Trial, 2007, 52. 17. Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999;54:581–586. 18. Enright PL, McBurnie MA, Bittner V, Tracy RP, McNamara R, Arnold A, et al. The 6 minute walk test: a quick measure of func- tional status in elderly adults. Chest 2003;123(2):387–398. 19. Holger J. Schünemann et al A Comparison of the Original Chronic Respiratory Questionnaire With a Standardized Version, Chest 2003;124;1421-1429 DOI 10.1378/chest.124.4.1421

20. American Thoracic Society medical section of the American lung association. Am J Respiratory Critical Care Med. 1999; 159, 1666–1682. 21. Chavannes N et al. Effects of physical activity in mild to moderate COPD: a systematic review, 2002, 574.

22. Ambrosino N et al. Pulmonary Rehabilitation Programs in COPD. Stenton C. The MRC breathlessness scale Oxford Journals Medicine Occupational Medicine. 1999, 58, 3: 226-227.

23. Elizabeth G. Eakin, et al Reliability and validity of dyspnea measures in patients with obstructive lung disease. International Journal of Behavioral Medicine, 1995, 118-134, 2:2.

24. K Al-shair, et al Development, dimensions, reliability and validity of the novel Manchester COPD fatigue scale. Thorax. 2009, 64, 950-955. 25. Salvatore Damato, et al Validation of the Clinical COPD questionnaire in Italian language. Health and Quality of Life Outcomes 2005, 1186/1477- 7525, 3-9. 26. Van der Molen T, Willemse BWM, Schokker S, ten Haken NHT, Postma DS, Juniper EF: Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes, 2003, 22, 1:13.

27. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test, Am J Respiratory Critical Care Med 2002, 166, 111-117.

28. Butland RJA, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease, BMJ 1982; 284, 1607–1608.

29. Enright PL, McBurnie MA, Bittner V, Tracy RP, McNamara R, New- man AB, the Cardiovascular Health Study. The six minute walk test: a quick measure of functional status in elderly adults. Chest (In press), 2003, 195.

30. Niederman MS, Clemente PH, Fein AM, Feinsilver SH, Robinson DA, Ilowite JS, Bernstein MG. Benefits of a multidisciplinary pulmonary rehabilitation program: improvements are independent of lung func- tion. Chest 1991, 99, 798–804.

31. Knox AJ, Morrison JF, Muers MF. Reproducibility of walking test re- sults in chronic obstructive airways disease. Thorax 1988, 43, 388–392. 32. Roomi J, Johnson MM, Waters K, Yohannes A, Helm A, Connolly MJ. Respiratory rehabilitation, exercise capacity and quality of life in chronic airways disease in old age. Age Ageing 1996, 25, 12–16.

33. Hajiro T, Nishimura K, Tsukino M, Ikeda A, Koyama H, Izumi T. Anal- ysis of clinical methods used to evaluate dyspnea in patients with COPD. Am J Respir Crit Care Med 1998, 158, 1185–1189.

34. Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpreting small differences in functional status: The six minute walk test in chronic lung disease patients. Am J Respir Crit Care Med 1997, 155, 1278–1282. 9. Signature of the candidate :

10. Remarks of the Guide

11. Name and Designation of

11.1 Guide : VARADHARAJ P. M.P.T. Asst. Professor

11.2 Signature :

11.3 Co-Guide : -

11.4 Signature : -

11.5 Head of the Department : Prof. S. NATARAJAN M.P.T.

11.6 Signature :

12. 12.1 Remarks of the Chairman and Principal

12.2 Signature :

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