1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (www.digitalresearchservices.ed.ac.uk/resources/data-vault).
   


6. For how long will this data be available start date provided 01-06-2029 and end date provided 30-06-2034?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

Low- and middle-income countries (LMICs) account for 80% of the total burden of chronic respiratory diseases (CRDs) and mortality. CRDs are the second most common cause of all deaths in India and contributed to almost 30% of all deaths and DALYs due to CRDs globally in 2019. CRDs and their symptoms can be controlled with treatment including medications and exercises. Pulmonary rehabilitation (PR) is a well-established non-pharmacological treatment option used in management of CRDs which has shown to improve symptom control and lung function. PR is a comprehensive, multidisciplinary, individually tailored intervention that overcomes the deconditioning induced by CRDs through endurance and muscle-strengthening exercises combined with education and coping mechanisms for breathlessness. However, most of the evidence is from high-income countries. This is a multi-country implementation trial in low- and middle-income country (LMIC) settings which will evaluate the effectiveness of centre and home-based PR over usual care, besides evaluating cost effectiveness, feasibility and sustainability.

This trial will be conducted across four centres and three countries with K V Kuppam block of RUHSA department being the study setting for CMC centre in India. A total of 465 study participants (confirmed cases of CRD, diagnosed by physician) will take part in this study with 120 participants from CMC centre who will be recruited after taking written informed consent and optimisation of treatment. They will be randomised to three groups -

1.      Centre-PR: a programme of exercise and education twice a week for 8 weeks at a PR Centre

2.      Home-PR: a programme of exercise and education twice a week for 8 weeks in their own homes, supervised remotely by video-call/telephone

3.      Usual Care: usual clinical care. At the end of the trial, this group will be offered their choice of Centre-PR or Home-PR

Before the start of PR, we will assess exercise capacity (Primary outcome) through Endurance Shuttle Walk test (ESWT) with minimum clinically important difference (MCID) of 174 seconds. The key secondary outcomes measured will be quality of life (HRQoL), breathlessness (mMRC dyspnoea scale), anxiety and depression (HADS), activities of daily living and physical activity (GPAQ). This will be repeated at 12 weeks and at 6 months to assess the impact of PR and measure whether benefits are maintained, respectively. We will measure the feasibility and acceptability through qualitative process evaluation and health economic impact through cost-effectiveness analysis.