Exploring physical activity levels of adults living with tuberculosis in Kyrgyzstan
| ISRCTN | ISRCTN17311066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17311066 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 28/08/2019
- Registration date
- 12/09/2019
- Last edited
- 08/07/2022
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
There is a wealth of literature demonstrating the benefits of physical activity, including reduced risk of heart disease, stroke, cancer, depression and dementia. It has been shown that adults with lung disease have reduced physical activity levels and higher stationary time compared to those without lung disease. However, this data has come from high income countries.
Chronic lung disease in low and middle income countries is highly prevalent and often associated with fumes from cooking on open stoves, air pollution and infections such as tuberculosis (TB). Data on physical activity and stationary time on adults living with TB in Kyrgyzstan is scarce.
Due to the importance of physical activity, the objective of this trial is to measure the physical activity levels and stationary time of adults living with TB in Kyrgyzstan. The information gathered will help guide future physical activity interventions.
Who can participate?
People over 18 years old who suffer from tuberculosis
What does the study involve?
Participants will wear a small device (accelerometer) to measure their activity levels for seven days.
What are the possible benefits and risks of participating?
Benefits of participation are to contribute to informing new knowledge of the physical activity levels of patients with post-TB lung disease in Kyrgyzstan. There are no risks to participation.
Where is the study run from?
National Center of Cardiology and Internal Medicine, Kyrgyzstan
When is the study starting and how long is it expected to run for?
September 2019 to March 2021
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 | Observational cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A cross sectional study examining physical activity levels and stationary time in adults living with tuberculosis: Global RECHARGE Kyrgyzstan |
| Study acronym | Global RECHARGE Kyrgyzstan (Physical activity) |
| Study objectives | Data is lacking surrounding the physical activity levels and stationary time of adults living with tuberculosis 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: Protocol #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: Protocol #17 2. Approval pending, University of Leicester Ethics Committee (The University of Leicester, University Road, Leicester, LE1 7RH, United Kingdom; ethicsapp@leicester.ac.uk), ref: |
| Health condition(s) or problem(s) studied | Tuberculosis |
| Intervention | Patients will be identified from the City TB Hospital, NCCIM and family medical centres jointly by the TB doctors and the rehabilitation team. Eligible patients will be informed verbally about the study by their clinician and they will be provided with a typed Patient Information Sheet written in their own language, and invited to take part in the study. They will be provided with an opportunity to ask questions, and if willing to take part in the study, they will be asked to provide written informed consent. Physical activity and stationary time will be assessed using a tri-axial accelerometer (Actigraph GT3x). Participants will be asked to wear the monitor during waking hours for seven consecutive days. Demographics will be recorded. |
| Intervention type | Other |
| Primary outcome measure | Volume and patterns of physical activity and stationary time measured using an accelerometer over seven consecutive days. |
| Secondary outcome measures | 1. Seasonal effects on activity (measured by accelerometer) assessed by stratifying the year into months and seasons (Spring, Summer, Autumn, Winter) 2. Bouts of activity (measured by accelerometer) |
| Overall study start date | 01/04/2018 |
| Completion date | 31/03/2021 |
| Reason abandoned (if study stopped) | This study was terminated before it began due to the impact of the COVID-19 pandemic on timelines and resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/05/2020 |
| Date of final enrolment | 30/04/2021 |
Locations
Countries of recruitment
- Kyrgyzstan
Study participating centre
Bishkek
720040
Kyrgyzstan
Sponsor information
University/education
University road
Leicester
LE1 7RH
England
United Kingdom
| Phone | 01162522522 |
|---|---|
| smd8@leicester.ac.uk | |
| Website | https://le.ac.uk/ |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2021 |
|---|---|
| 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 | 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. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
08/07/2022: This study was terminated before it began due to the impact of the COVID-19 pandemic on timelines and resources.
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 30/09/2019 to 01/05/2020.
2. The recruitment end date was changed from 31/03/2021 to 30/04/2021.
23/10/2019: The ethics approval information has been updated.
09/10/2019: Internal review.
29/08/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)
