Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Dr Mark Orme
ORCID ID
http://orcid.org/0000-0003-4678-6574
Contact details
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre- Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
+441162583113
mwo4@leicester.ac.uk
Type
Scientific
Additional contact
Dr Mark Orme
ORCID ID
http://orcid.org/0000-0003-4678-6574
Contact details
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre- Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
+441162583113
mwo4@leicester.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Version 1
Study information
Scientific title
A cross sectional study examining physical activity levels and stationary time in adults living with tuberculosis: Global RECHARGE Kyrgyzstan
Acronym
Global RECHARGE Kyrgyzstan (Physical activity)
Study hypothesis
Data is lacking surrounding the physical activity levels and stationary time of adults living with tuberculosis in Kyrgyzstan
Ethics approval
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:
Study design
Observational cross sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
01/04/2018
Overall trial end date
31/03/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
01/05/2020
Recruitment end date
30/04/2021
Locations
Countries of recruitment
Kyrgyzstan
Trial participating centre
National Center of Cardiology and Internal Medicine
3 Togolok Moldo Street
Bishkek
720040
Kyrgyzstan
Sponsor information
Organisation
University of Leicester
Sponsor details
University road
Leicester
LE1 7RH
United Kingdom
01162522522
smd8@leicester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
31/03/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list