Does Pulmonary Rehabilitation improve the health of people in Kyrgyzstan living with lung disease caused by tuberculosis?
| ISRCTN | ISRCTN11122503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11122503 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 28/08/2019
- Registration date
- 12/09/2019
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Chronic lung disease in low- and middle-income countries (LMICs) is associated with indoor air pollution, tobacco smoking and infections such as tuberculosis (TB). Chronic lung disease usually affects the most vulnerable in developing countries where people are unable to work from a younger age, compared with high income countries.
People living with post-TB lung disease are frequently disabled by their breathlessness. As a result, the individual experiences a reduced ability to perform daily activities, poor quality of life and social isolation. The disease is characterised by sudden flare-ups of symptoms, when symptoms become severe and the level of disability increases. Furthermore, medication in LMICs countries remains largely unavailable, expensive, and does not reverse the disability caused by TB.
Pulmonary Rehabilitation is a non-drug, low cost, high impact intervention that reverses the disability associated with chronic lung disease through education and exercise. It brings together health professionals from many disciplines, offering supervised exercise training and disease education. However, Pulmonary Rehabilitation is largely unavailable in developing countries. The project aims to develop culturally appropriate Pulmonary Rehabilitation and determine whether it is effective in improving the health of people living with lung disease caused by TB.
The aims of this project are to:
1. Adapt traditional Pulmonary Rehabilitation (PR) by incorporating music, singing and dancing as part of PR classes by patients and healthcare staff
2. Assess the impact of Pulmonary Rehabilitation on walking distance and quality of life for people living with post-TB lung disease in a randomised controlled trial
3. Explore differences in how patients respond to completing Pulmonary Rehabilitation
Who can participate?
In the first stage of the study, patients with chronic obstructive pulmonary disease (COPD) and healthcare staff who refer patients to PR programmes can take part.
In the second stage of the study people over 18 years old who suffer from tuberculosis can take part.
What does the study involve?
Patients and healthcare staff involved in Pulmonary Rehabilitation will discuss a new music, singing and dancing part to Pulmonary Rehabilitation to help make the service more culturally relevant to the people of Kyrgyzstan.
Participants with post-tuberculosis lung disorder will be randomly assigned to either Pulmonary Rehabilitation or a control group. The Pulmonary Rehabilitation programme will consist of 6 weeks of hospital-based education and exercises conducted twice weekly followed by a further 6 weeks of observation. The control group will consist of usual care. The study will assess whether Pulmonary Rehabilitation improves walking capacity, quality of life and symptom burden.
What are the possible benefits and risks of participating?
Pulmonary rehabilitation is not routinely available for people living with post-TB lung disease. We envisage participants benefiting from taking part in the intervention. Benefits may include improved fitness and reduced severity of symptoms such as breathlessness or chest tightness. There are no anticipated risks of participating.
Where is the study run from?
National Center of Cardiology and Internal Medicine named after Mirrakhimov, Kyrgyzstan
When is the study starting and how long is it expected to run for?
September 2019 to June 2022
Who is funding the study?
National Institute for Health Research (NIHR), UK
Who is the main contact?
Dr Mark Orme,
mwo4@leicester.ac.uk
Contact information
Public
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre - Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0003-4678-6574 |
|---|---|
| Phone | +441162583113 |
| mwo4@leicester.ac.uk |
Scientific
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre - Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| ORCID ID |
0000-0003-4678-6574 |
|---|---|
| Phone | +441162583113 |
| mwo4@leicester.ac.uk |
Study information
| Study design | Randomised wait-list controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Pulmonary Rehabilitation for people living with Post-TB lung disease in Kyrgyzstan: Global RECHARGE Kyrgyzstan |
| Study acronym | Global RECHARGE Kyrgyzstan |
| Study hypothesis | Pulmonary Rehabilitation will improve exercise capacity and health-related quality of life for people living with post-TB lung disease in Kyrgyzstan |
| Ethics approval(s) | Current ethics approval as of 23/10/2019: 1. Approved 22/07/2019, Ethics Committee, National Centre of Cardiology and Internal Medicine (3 Togolok Moldo str, 720040, Bishkek, Kyrgyz Republic), ref: no. 17 2. Approved 16/09/2019, University of Leicester Ethics Committee (The University of Leicester, University Road, Leicester, LE1 7RH, United Kingdom; +44 (0)1162522522; ethicsapp@leicester.ac.uk), ref: 22293 Previous ethics approval: 1. Approved 22/07/2019, Ethics Committee, National Centre of Cardiology and Internal Medicine (3 Togolok Moldo str, 720040, Bishkek, Kyrgyz Republic), ref: no. 17 2. Approval pending, University of Leicester Ethics Committee (The University of Leicester, University Road, Leicester, LE1 7RH, UK; ethicsapp@leicester.ac.uk) |
| Condition | Post-TB lung disease |
| Intervention | This trial will consist of a mixed-methods approach and recruitment for each stage will be separate. The trial consists of two stages: 1. Focus groups will be conducted with adults with a diagnosis of post-TB lung disease and interviews will be conducted with potential referrers to Pulmonary Rehabilitation (healthcare staff). 2. A wait-list RCT of Pulmonary Rehabilitation versus usual care (control). Participants will be individually randomised (1:1) to the Pulmonary Rehabilitation programme or to a waiting list control. Due to the nature of Pulmonary Rehabilitation, it will not be possible for patients to be blinded to the allocation. All measures will be taken by a blinded assessor. The intervention (Pulmonary Rehabilitation) will consist of a six-week programme, with sessions occurring twice weekly for at least two hours with approximately one hour for education and one hour for exercise, singing and dancing. It will be provided by a team of respiratory doctors, physiotherapists and nurses. The education component focuses on causes of breathlessness, coping techniques, the role of smoking, biomass smoke, TB and HIV, and the value of exercise. The standard programme of education will be supplemented by additional material on an individual basis or in small groups of people with post-TB lung disease. The exercise component consists of a combination of resistance and aerobic training using minimal equipment, individually adjusted over the course of six weeks. Classes will also include dedicated singing and dancing components which will be informed by patients as part of the trial. Pulmonary Rehabilitation will be provided in groups of up to 10 people with post-TB lung disease. The exercise regime will be individually prescribed to participants based on their exercise capacity. The regime is based on international guidance and will consist of the following: 1. Stretching/ flexibility exercises 2. Resistance training for upper and lower limbs including sit to stand, step-ups, bicep curls and pull-ups 3. Endurance exercises included walking and cycling on a stationary bike 4. Singing and dancing (informed by patients and health professionals) The data gathered from stage 1 will inform the music, singing and dancing component of Pulmonary Rehabilitation and also the structure and content of the Pulmonary Rehabilitation classes. Outcomes will include a definition of the optimum music component including types of music and songs, dances, duration of the component, and how it is best delivered within the Pulmonary Rehabilitation programme. The patients on the waiting list (control) arm will receive usual care and will be offered Pulmonary Rehabilitation after completing 12-week follow-up outcomes. There are currently no guidelines for the clinical management of Post-TB lung disease both locally and internationally. The usual care received by patients with post TB lung disease includes the following: 1. Frontal chest radiograph 2. Spirometry to screening for airway diseases 3. Optimised drug treatment 4. Advice to reduce exposures to risk factors e.g tobacco smoking, biomass smoke Participants will in addition receive a leaflet with educational material about their lungs, which will be designed for this study together with patients. The information will cover the main needs of people living with post-TB lung disease and the importance of a healthy lifestyle including smoking cessation, exercises, diet, and self-management. |
| Intervention type | Behavioural |
| Primary outcome measure | Walking distance (exercise capacity) on the Incremental Shuttle Walk Test (ISWT) at baseline and 6 weeks |
| Secondary outcome measures | 1. Breathlessness is measured using the Medical Research Council (MRC) dyspneoa scale at 6 weeks 2. Symptom severity is measured using the COPD Assessment Test at 6 weeks 3. Health-related quality of life is measured using the Clinical COPD Questionnaire at 6 weeks 4. Economic impact is measured using the Work Productivity and Activity Impairment questionnaire at 6 weeks 5. Quality of life is measured using the EQ5D-5L questionnaire at 6 weeks 6. Anxiety and depression are measured using the Hospital Anxiety and Depression Scale at 6 weeks 7. Physical activity is measured using accelerometry at 6 weeks 8. Pain is measured using the chest pain questionnaire at 6 weeks 9. Exercise capacity is measured using the Endurance Incremental Shuttle Walk Test at 6 weeks 10. Physical function is measured using the 5x Sit to Stand test at 6 weeks 11. End of study patient focus groups: Participants allocated to the intervention group will be invited to participate in focus group discussions at the end of their Pulmonary Rehabilitation programme to learn about their experience of Pulmonary Rehabilitation. Focus groups will give an insight on views, experiences, opinions and recommendations which will be then helpful to inform design of future PR programmes. We anticipate conducting up to 6 focus groups with 2-10 participants in each. We will invite participants from the intervention group who completed the Pulmonary Rehabilitation programme and who dropped out of Pulmonary Rehabilitation to understand their experiences of the intervention. Focus group discussions will be audio-recorded, each lasting approximately 45-60 minutes, and will be conducted face-to-face by an interviewer and note taker (observer). Focus groups will be transcribed verbatim, with identifiable information removed. 12. End of study staff interviews: Health care personnel involved in Pulmonary Rehabilitation will be invited to participate in interviews at the end of the study to discuss aspects of feasibility and acceptability, such as insights into barriers and facilitators to referral, uptake and completion of Pulmonary Rehabilitation. Interviews will be audio-recorded, each lasting approximately 30-45 minutes, and will be conducted face-to-face by an interviewer. Interviews will be transcribed verbatim, with identifiable information removed. 13. Book of testimonies collected throughout study: Patients attending Pulmonary Rehabilitation will be asked to log their experience of the programme as they progress. This will be in the form of a Pulmonary Rehabilitation log book accessible to patients before, during and after sessions, as well as a dedicated patient evaluation form. Participants will be regularly prompted in order to gain the experiences of as many patients as possible. Patient satisfaction will also be recorded using a survey; staff involved in Pulmonary Rehabilitation will also receive the same evaluation form at the end of the study. |
| Overall study start date | 01/04/2018 |
| Overall study end date | 30/06/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 114 |
| Total final enrolment | 114 |
| Participant inclusion criteria | Stage 1 (patient): 1. Aged ≥18 years 2. Physician diagnosis of COPD Stage 1 (staff): 1. Healthcare staff that would typically refer patients to a clinical PR programme, such as physicians & clinicians. Stage 2: 1. Aged ≥18 years; 2. Definite diagnosis of a TB-negative patients with PTBLD lung disease 3. Previous TB treatment or finished treatment 4. Medical Research Council dyspnoea score grade 2 or higher |
| Participant exclusion criteria | Stage 1 (patients): 1. Unable or unwilling to provide informed consent Stage 2 (staff): 1. Unable or unwilling to provide informed consent Stage 2: 1. Comorbidities such as severe or unstable cardiovascular, other internal diseases and locomotor difficulties that preclude exercise 2. Malignant disease such as lung cancer 3. Evidence of active TB on Chest X-ray or sputum tests within 1 month of assessment 4. Unable or unwilling to provide informed consent. |
| Recruitment start date | 12/10/2019 |
| Recruitment end date | 30/06/2022 |
Locations
Countries of recruitment
- Kyrgyzstan
Study participating centre
Bishkek
720040
Kyrgyzstan
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44116 252 2522 |
|---|---|
| smd8@leicester.ac.uk | |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is anticipated that the results from this study will be published in international journals and presented locally, nationally and internationally at appropriate meetings and conferences. All data that will be collected is anticipated to be published. Updated 03/11/2021: RECHARGE will be publicised through social media (Twitter @Global_RECHARGE), on a website (https://www.globalrecharge.org.uk/), conference abstracts and peer-reviewed journal articles. |
| IPD sharing plan | For expressions of interest in collaborating, contributing research data to the database or for data access please contact the RECHARGE Scientific Committee by email at recharge@le.ac.uk. Please have a look at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7688060/ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | Qualitative results | 04/02/2022 | 07/02/2022 | Yes | No |
| Protocol article | 21/02/2022 | 23/02/2022 | Yes | No | |
| Statistical Analysis Plan | version 1.0 | 09/10/2023 | 10/10/2023 | No | No |
Additional files
Editorial Notes
10/10/2023: The statistical analysis plan was added.
05/09/2023: The following changes have been made:
1. The overall end date was changed from 21/09/2022 to 30/06/2022.
2. The intention to publish date was changed from 30/09/2023 to 30/09/2024
28/09/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2022 to 21/09/2022.
2. The total final enrolment was added.
08/06/2022: The intention to publish date was changed from 31/03/2023 to 30/09/2023.
04/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 30/06/2022.
2. The overall trial end date has been changed from 30/05/2022 to 30/09/2022 and the plain English summary has been updated to reflect this change.
23/02/2022: Publication reference added.
07/02/2022: Publication reference added.
07/12/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2021 to 31/03/2022.
2. The overall trial end date was changed from 31/03/2021 to 30/05/2022.
3. The intention to publish date was changed from 31/03/2021 to 31/03/2023.
03/11/2021: Publication and dissemination plan and IPD sharing statement updated.
10/02/2021: Recruitment for this study is no longer paused and the following changes have been made:
1. The recruitment start date has been changed from 17/10/2019 to 12/10/2019.
2. The recruitment end date has been changed from 31/12/2020 to 31/12/2021.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
02/03/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 30/11/2019 to 17/10/2019.
2. The recruitment end date was changed from 30/09/2020 to 31/12/2020.
23/10/2019: The ethics approval information has been changed.
02/09/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)
