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CTRI Number  CTRI/2024/10/075277 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Pulmonary Rehabilitation]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Pulmonary rehabilitation in low resource settings for people with breathlessness due to lung conditions 
Scientific Title of Study   Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind randomised implementation trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parag Gajanan Khatavkar 
Designation  Consultant 
Affiliation  KEM Hospital Research Centre 
Address  Respiratory Medicine Department, First Floor, TDH Building, KEM Hospital Researh Centre, Sardar Moodliar Road, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9890141514  
Fax    
Email  p.khatavkar@kemhrcpune.org  
 
Details of Contact Person
Scientific Query  
Name  Parag Gajanan Khatavkar 
Designation  Consultant 
Affiliation  KEM Hospital Research Centre 
Address  Respiratory Medicine Department, First Floor, TDH Builidng, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9890141514  
Fax    
Email  p.khatavkar@kemhrcpune.org  
 
Details of Contact Person
Public Query  
Name  Parag Gajanan Khatavkar 
Designation  Consultant 
Affiliation  KEM Hospital Research Centre 
Address  Respiratory Medicine Department, First Floor, TDH Building, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9890141514  
Fax    
Email  p.khatavkar@kemhrcpune.org  
 
Source of Monetary or Material Support  
Medical Research Council, UK Research and Innovation Caxton House Tothill Street London SW1H 9NA 
 
Primary Sponsor  
Name  Medical Research Council 
Address  Applied Global Health Research Board, Reference Number MR/Y004809/1, United Kingdom 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Biswajit Paul  Christian Medical College  Chittoor Campus, 190 Ramapuram Village, 189 Kothapalle Post, Gudipala Mandal,Chittoor - 517132
Chittoor
ANDHRA PRADESH 		 8124034755

drbpaul@cmcvellore.ac.in 
Parag Khatavkar  KEM Hospital Research Centre  Sardar Moodliar Road, Rasta Peth, Pune 411011
Pune
MAHARASHTRA 		 02066037338

drpgkhatavkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Review Board (Silver Ethics and Research Committee) of the Christian Medical College Vellore  Approved 
KEM Hospital Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Center based pulmonary rehabilitation.   Intervention delivered at study centre. Twice a week for total 8 weeks. It is comprehensive, multidisciplinary, individually-tailored intervention. Components include tailored exercise, education, self-management/lifestyle change 
Intervention  Home based pulmonary rehabilitation.   Intervention delivered at home and monitored remotely. Twice a week for total 8 weeks. It is comprehensive, multidisciplinary, individually-tailored intervention. Components include tailored exercise, education, self-management/lifestyle change  
Comparator Agent  Usual Care  The routine health care available within their local healthcare service. Health care would be sought by the participant as and when required. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  • Adults 18years old (the age of majority in all the countries). No upper age limit.
• Assessed by referring physician as having persistent and functionally limiting respiratory symptoms (mMRC more than 2) after optimisation of pharmacological therapy.
• Resident locally and willing to engage with either Centre-PR and Home-PR schedules if randomised to either of these groups.
• Willing and able to provide written informed consent.
 
 
ExclusionCriteria 
Details  • People with non-respiratory causes for the symptoms (stable co-morbidity may be included if clinically appropriate).
• Active TB infection.
• Any condition that would increase risk (e.g. uncontrolled cardiac disease) interfere with PR (e.g. neurological disorders, severe arthritis, dementia).[44] or be inappropriate (very severe frailty, end-of-life)
• On-going, or completed PR (including other exercise programme) within previous 18 months.
• Living in the same house as another participant
• Unwilling or unable to provide informed consent.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Endurance Shuttle Walking Test (ESWT)  8 weeks post intervention and 6 months post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Health related quality of life (HRQoL);anxiety/depression level, breathlessness level, physical activity level  8 weeks post intervention and 6 months post intervention 
 
Target Sample Size   Total Sample Size="117"
Sample Size from India="117" 
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)   01/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Pulmonary rehabilitation (PR) is a comprehensive, multidisciplinary, individually-tailored intervention that overcomes the deconditioning induced by chronic respiratory diseases (CRDs). In Low- and Middle-Income Counties (LMICs), CRDs may be poorly differentiated, and PR inaccessible and under-resourced. Our objective is to test the clinical/cost effectiveness, sustainability at 6-months, acceptability and implementability of Centre- or Home-PR delivered in lowresource centres for people with CRDs compared to usual care. Four Centres will be participating (Bangladesh, India x2, Malaysia). Total 465 adults with symptomatic CRD will be enrolled. This will be 3-arm individually-randomised, assessor-blinded 6-month hybrid-1 implementation trial, with health economic and process evaluations. Following initial centre-based teaching of personalised exercise/education programme, two approaches to delivering PR:

1. Centre-PR: centre-based sessions twice weekly for 8 weeks

2. Home-PR: Remotely supervised sessions at home twice weekly for 8 weeks

Usual care group: Locally available healthcare (choice of Centre- or Home- PR at the end of the trial)

Primary outcome: Endurance Shuttle Walking Test (ESWT)

Key secondary outcomes: Quality of Life: St Georges Respiratory Questionnaire (SGRQ)

Other outcomes: mMRC Dyspnoea Score; Hospital Anxiety and Depression Score; smoking status; Activities of Daily Living; Physical Activity; adverse events; use of healthcare resources. Researcher-blind assessments (baseline; post-PR; 6-months) will be done. 

ESWT will be analysed using a normal linear model, with treatment allocation, baseline ESWT and Centre included as fixed effect covariates. Cost-consequence analysis of health care cost, out of pocket expenses and impact on work productivity. Mixed methods assessment of fidelity/adaptation, mechanisms of action, acceptability and sustainability will be implemented.

 
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