A feasibility trial of community-based pulmonary rehabilitation for adults with chronic obstructive pulmonary disease (COPD) in India
| ISRCTN | ISRCTN15546359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15546359 |
- Submission date
- 05/10/2021
- Registration date
- 05/10/2021
- Last edited
- 30/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
India has the largest number of chronic obstructive pulmonary disease (COPD) cases in the world and ranks second in COPD mortality worldwide. COPD is a long-term inflammatory lung disease that causes difficulty breathing, cough, mucus (sputum) production and wheezing. It's often caused by long-term exposure to cigarette smoke. Since COPD is a progressive, non-curable condition, rehabilitation of the patient becomes the most plausible therapeutic intervention.
International guidelines recommend that pulmonary rehabilitation (PR) should be offered to adults living with COPD. PR reverses the disability associated with Chronic Respiratory Diseases (CRDs), which is supported by the highest level of evidence. The World Health Organization makes the case for the fundamental role of accessible and affordable rehabilitation and acknowledges an unmet need that is profound in low- and middle-income countries (LMICs) where demand greatly outweighs capacity.
Who can participate?
Adults aged between 18 and 65 years with a diagnosis of COPD and functional limitation due to breathlessness.
What does the study involve?
Eligible study participants will participate in a six-week, twice-weekly, supervised community-based pulmonary rehabilitation (PR) programme. Assessment of participants' lung function, exercise tolerance, and health status will be conducted. In addition, semi-structured in-depth interviews with participants will be conducted after their participation in the PR programme.
What are the possible benefits and risks of participating?
Participation will help inform the design of a culturally appropriate pulmonary rehabilitation (PR) programme for people with COPD in Jodhpur (India). Risks from participation are not anticipated.
Where is the study run from?
Indian Council of Medical Research – National Institute for Implementation Research on Non-Communicable Diseases (India)
When is the study starting and how long is it expected to run for?
October 2021 to March 2023
Who is funding the study?
National Institute for Health Research (NIHR) Global Health Research Group on Respiratory Rehabilitation (Global RECHARGE) (UK)
Who is the main contact?
Dr Arun Kumar Sharma
a.sharma@icmr.gov.in
Contact information
Scientific
Director of ICMR-National Institute for Implementation Research on Non-Communicable Diseases
New Pali Road
Jodhpur
342005
United Kingdom
| Phone | +91-291-2722403 |
|---|---|
| a.sharma@icmr.gov.in |
Scientific
ICMR-National Institute for Implementation Research on Non-Communicable Diseases
New Pali Road
Jodhpur
342005
United Kingdom
| Phone | No telephone contact available |
|---|---|
| mahendra.t@icmr.gov.in |
Study information
| Study design | Single-centre mixed-methods single-arm non-randomized cohort feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A single-arm feasibility trial of community-based pulmonary rehabilitation for adults with COPD in the slum areas of Jodhpur, Rajasthan |
| Study objectives | 1. Determine the feasibility of conducting community-based PR for people living with COPD in residents of slum areas in Jodhpur, Rajasthan 2. Assess the acceptability of community-based PR among Indian adults living with COPD and healthcare staff involved in its delivery 3. Describe any changes in the health of the adults living with COPD following completion of PR 4. Assess the feasibility of a future trial and estimate the required sample size |
| Ethics approval(s) | 1. Approved 09/08/2021, Institutional Ethics Committee & Health Research (ICMR-NIIRNCD Jodhpur (Rajasthan), India; +91 (0)11-27298472; membersecyniirncd@gmail.com), ref: IEC-ICMR NIIRNCD/2021/25/11 2. Approved 10/11/2021, University of Leicester Ethics Committee (The University of Leicester, University Road, Leicester, LE1 7RH, United Kingdom; +44 (0)1162522522; ethicsapp@leicester.ac.uk), ref: 32024 3. Approved 26/10/2021, Institutional Human Ethics Committee & Health (Room no 116, first floor, Medical College, All India Institute of Medical Science, Basni, Phase-II, Jodhpur, Rajasthan-342005; +91 (0)291-2012984 ext: 3109; ethicscommitteeaiimsjdh@gmail.com), ref: ECR/866/Inst/RJ/2016/RR-19 |
| Health condition(s) or problem(s) studied | Chronic Obstructive Pulmonary Disease (COPD) |
| Intervention | In addition to usual care, participants in the intervention arm will receive pulmonary rehabilitation (PR). PR will comprise the core elements of an evidence-based rehabilitation, a programme of exercises and health education will consist of a six-week programme offered to a group of up to 12 participants, with sessions occurring twice weekly for at least 2 h (approximately 1 h for education and 1 h for exercise). All staff delivering PR will be trained and assisted by a medical doctor (M.B.B.S) and by a Medical Social Worker. The venue will have a maximum capacity of 6-8 patients per PR class and this will be continuously reviewed to ensure patient safety during COVID pandemic. The equipment required will be simple and include chairs, weights, and simple exercise equipment based on local availability and suitability. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility and the acceptability of the PR intervention measured using semi-structured in-depth interviews with participants at 6 weeks |
| Secondary outcome measures | 1. Lung function measured using the following at baseline and 6 weeks: 1.1. Spirometry to calculate pre- and post-bronchodilator forced expiratory volume in one second [FEV1], forced vital capacity [FVC], and FEV1/FVC ratio 1.2. Questionnaires to calculate smoking status and number of COPD exacerbations in the last year 2. Health status measured using the following at baseline and 6 weeks: 2.1. Participant perceived respiratory disability due to dyspnea using the Medical Research Council (MRC) dyspnea scale 2.2. Health-related quality of life using the chronic obstructive pulmonary disease assessment test (CAT) 2.3. Economic impact using the Work Productivity and Activity Impairment (WPAI) questionnaire 2.4. Emotional health using the Hospital Anxiety and Depression Scale (HADS) 3. Physical fitness measured using the following at baseline and 6 weeks: 3.1. Exercise capacity using the incremental shuttle walk test (ISWT) and the endurance shuttle walking test (ESWT) 3.2. Lower extremity muscular strength using a five-repetition sit-to-stand test (5XSST) |
| Overall study start date | 01/10/2021 |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 9 |
| Key inclusion criteria | 1. Aged 18 to 65 years 2. Spirometry confirmed diagnosis of chronic obstructive pulmonary disease (COPD) 3. Functional limitation due to breathlessness reaching a score of ≥2 on the Medical Research Council (MRC) dyspnea scale |
| Key exclusion criteria | 1. Significant comorbidities such as cardiovascular, neurological, locomotor difficulties that preclude exercise, cognitive, malignant disease, or any other condition that would compromise participation in the rehabilitation programme 2. COVID-19 RT-PCR positive result within 3 days of assessment 3. Unable to provide informed consent. |
| Date of first enrolment | 24/01/2022 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- India
Study participating centres
Air force Area
Jodhpur
342005
India
MIA 2nd Phase
Basni
Jodhpur
342005
India
Sponsor information
University/education
University road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 (0) 1162522522 |
|---|---|
| ip150@leicester.ac.uk | |
| Website | http://www.le.ac.uk |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the trial will be disseminated through oral presentations at local and international scientific conferences or seminars and publication in a peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 07/09/2020 | 01/03/2024 | No | No |
Additional files
Editorial Notes
30/04/2024: The intention to publish date was changed from 31/03/2024 to 31/12/2024.
01/03/2024: Protocol uploaded. Ethics approval and total final enrolment added.
28/10/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2022 to 31/01/2023.
2. The overall end date was changed from 31/01/2023 to 31/03/2023.
3. The intention to publish date was changed from 30/09/2023 to 31/03/2024.
4. The plain English summary was updated to reflect these changes.
31/08/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2022 to 31/01/2023.
2. The recruitment end date was changed from 31/08/2022 to 31/10/2022.
3. The plain English summary was updated to reflect these changes.
21/03/2022: The recruitment end date has been changed from 31/03/2022 to 31/08/2022.
24/01/2022: The recruitment end date has been changed from 31/01/2022 to 31/03/2022.
10/01/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/02/2022 to 24/01/2022.
2. The recruitment end date has been changed from 01/02/2022 to 31/01/2022.
08/12/2021: The recruitment start date has been changed from 01/12/2021 to 01/02/2022.
05/10/2021: Trial’s existence confirmed by the National Institute for Health Research (NIHR).
