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CTRI Number  CTRI/2020/01/022893 [Registered on: 21/01/2020] Trial Registered Prospectively
Last Modified On: 20/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Home Based Pulmonary rehabilitation for people with Bronchiectasis 
Scientific Title of Study   Effectiveness of Structured Home-based Pulmonary Rehabilitation program on Functional capacity and Quality of Life in Bronchiectasis: A randomized controlled trial 
Trial Acronym  HoPro 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anup Bhat 
Designation  Assistant Professor 
Affiliation  Manipal College of Heatlh Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  08202922533  
Fax    
Email  anup_251@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Anup Bhat 
Designation  Assistant Professor 
Affiliation  Manipal College of Heatlh Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions
Manipal Academy of Higher Education

KARNATAKA
576104
India 
Phone  08202922533  
Fax    
Email  anup_251@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Anup Bhat 
Designation  Assistant Professor 
Affiliation  Manipal College of Heatlh Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions
Manipal Academy of Higher Education

KARNATAKA
576104
India 
Phone  08202922533  
Fax    
Email  anup_251@yahoo.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka - 576104 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Manipal.edu, Madhavnagar, Manipal, Udupi, Karnataka - 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anup Bhat  Kasturba Hospital, MAHE, Manipal  Cardiopulmonary and Fitness Unit, Department of Physiotherapy, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka - 576104
Udupi
KARNATAKA 		 9916820026

anup_251@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J471||Bronchiectasis with (acute) exacerbation, (2) ICD-10 Condition: J479||Bronchiectasis, uncomplicated,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Control group will receive standard medical care which includes medical, physiotherapy and life style modification 
Intervention  Structured Home-based Pulmonary Rehabilitation  1.Bronchial Hygiene therapy – Practical Demonstration of Postural drainage position based on the pulmonary segment involved and a hand out on postural drainage position and its benefits or Active cycle of breathing Technique (Informal lecture and content will be present in the booklet too) (content of the booklet and the video will be content validated by the experts) 2.Physical Activity Promotion – by creating awareness of benefits of physical activity (Informal lecture and booklet) (content of the booklet and the video will be content validated by the experts) 3.A booklet on self-management of disease and educational topics will be provided (content of the booklet and the video will be content validated by the experts) 4.Nutritional advise by providing the diet chart for patients with bronchiectasis 5.Addressing the breathlessness: Pursed lip breathing during breathlessness and during activity that triggers breathlessness, exercising in front of a fan or in front of an open window allowing fresh breeze will be advised. Patient will be advised to breathe out just before putting effort whenever the patient must perform a physical activity which he considers hard. For example, lifting weights, bags. 6. Exercise training a) strength training: F – 2 times/week I – Body weight, 10 repetitions T – Body weight exercises – Wall Squats, wall push-ups, 1 flight stair climbing T – 2 sets P – Increasing the repetitions every week by 2 repetitions b) Aerobic training: F – 3 times/ week I – 80% of 6MWT speed T – 20 minutes + 5 minutes of Warmup and 5 minutes of Cool down T – Walking P – Duration to be increased by 5 minutes after every 2 weeks c)Flexibility training: F – 3 times/week I – Minimal stretch sensation and 3 repetitions T – Self stretches – Tendoachilles, Quadriceps, Pectoralis major, Hamstrings T – 30 seconds hold Telephone reminders will be provided to the intervention group to perform the exercises every week and any concerns related to exercises will be answered. Compliance will be assessed by informally interviewing the family member of patient Familiarization of the intervention: Intervention will be provided and demonstrated in the hospital during their stay, 2 days before discharge (Post exacerbation bronchiectasis patients) Intervention will be supervised during their stay in the hospital and will be encouraged to discuss their concerns regarding the intervention  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  A physician diagnosed post exacerbation bronchiectasis patients between the age group 18- 70 years, either gender, any etiology with any mMRC dyspnea grade and Functional vision and hearing 
 
ExclusionCriteria 
Details  Patients who are diagnosed with endocrine, musculoskeletal and neurological disorders which prevent a person from exercising, primary Cardiac disorders and Coronary artery disease 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional capacity using Six minute walk distance and quality of life using Bronchiectasis Health Questionnaire and St George respiratory questionnaire  Baseline, 2 months (after 24 sessions) and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Dyspnea on mMRC scale, Muscular strength using estimated 1 Repetition Maximum, energy cost in walking using Physiological cost index, Body composition using Bioelectrical impedance analyzer, Physical activity level using Stanford 7 day Physical activity recall questionnaire  Baseline, 2 months (after 24 sessions) and 3 months 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/01/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Bronchiectasis is a chronic respiratory disease with chronic cough and expectoration and exercise intolerance. Out patient based pulmonary rehabilitation is found to be effective in patients with bronchiectasis. However, this is not a feasible model for many patients in resource limited settings. In order to improve accessibility, home based pulmonary rehabilitation models has been tested in other chronic respiratory diseases and found to be effective. Effect of home based pulmonary rehabilitation in bronchiectasis patients with limited resources has not been established. This randomized controlled trial aims to determine the effectiveness of structured home based pulmonary rehabilitation in bronchiectasis patients on functional capacity and health related quality of life. A total of 104 subjects will be randomized into intervention group (n=52) and control group (n=52) using stratified block randomization so that each group has 26 males and 26 females. Outcome assessor will be blinded to group allocation. Intervention group will receive home based pulmonary rehabilitation which includes airway clearance techniques, nutritional advice, physical activity promotion, self management educational booklet, exercise training (strength, aerobic & flexibility training) and dyspnea relieving techniques. Control group will receive standard care as per physician orders which includes medical, physiotherapy and life style management. Outcomes will be assessed at baseline, end of intervention (after 24 sessions) and at the end of 3 months. 
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