Condition category
Respiratory
Date applied
28/08/2019
Date assigned
12/09/2019
Last edited
12/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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, Kyrgystan

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

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

30/09/2019

Recruitment end date

31/03/2021

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

https://le.ac.uk/

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

Publication citations

Additional files

Editorial Notes

29/08/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)