What are the physical activity levels, exercise capacity, nutritional status and lung function of people in Sri Lanka living with chronic obstructive lung disease?
| ISRCTN | ISRCTN62842477 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62842477 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 28/08/2019
- Registration date
- 12/09/2019
- Last edited
- 06/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Lung conditions are a major problem in Sri Lanka and many other low- and middle- income countries and little is known about the potentially broad range of negative impacts these conditions may have on the lives of patients. Most of the researcher in this area has come from high-income countries. In order for effective and culturally appropriate interventions to be created for adults living with COPD in Sri Lanka, further information is needed, including a detailed profiling of the nutritional status, exercise capacity, lung health and physical activity levels of this population. It is anticipated that the data gathered in this study will guide future interventions, including a culturally appropriate pulmonary rehabilitation intervention.
Who can participate?
People in Sri Lanka living with COPD
What does the study involve?
In a one-off visit lasting 60-90 minutes, the following assessments are performed: assessment of socio-demographic status, co-morbidities and medications; assessment of lung health and lung function; nutritional status assessed through measures of height, weight and body composition; disease burden and psychological well-being assessed through questionnaires; exercise capacity assessed using a walking test and physical function assessed using the sit to stand test. Physical activity levels are measured by wearing a device for 7 days during waking hours.
What are the possible benefits and risks of participating?
Benefits of participation are to contributing to new knowledge of the health status of patients living with COPD in Sri Lanka. There are no risks to participation.
Where is the study run from?
Central Chest Clinic, Western District, Colombo, Sri Lanka
When is the study starting and how long is it expected to run for?
April 2018 to May 2023
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 | +44 (0)1162583113 |
| 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 | +44 (0)1162583113 |
| mwo4@leicester.ac.uk |
Study information
| Study design | Single-centre observational (cross sectional) study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Cross-sectional assessment of people living with COPD in Sri Lanka who meet the criteria for attending a pulmonary rehabilitation programme: Global RECHARGE Sri Lanka |
| Study acronym | Global RECHARGE Sri Lanka |
| Study objectives | There is limited information regards the nutritional status, physical activity levels, exercise capacity and lung function of people in Sri Lanka living with chronic obstructive pulmonary disease (COPD). |
| Ethics approval(s) | Approval pending, Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka & University of Leicester Ethics Committee (University of Leicester, University Road, Leicester, LE1 7RH, UK; Email: ethicsapp@leicester.ac.uk) |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | Assessment of socio-demographic status, co-morbidities and medications will be obtained through self-report measures. Assessment of lung health and lung function will occur, including spirometry. Nutritional status will be assessed through measures of height, weight, body composition (estimated through bioelectrial impedance analysis and skin fold thickness) and mid-upper arm circumference. Disease burden and psychological well-being will be assessed through self-report questionnaires. A questionnaire quantifying disease burden on work and activity impairment will also be used (Work Productivity and Activity Impairment questionnaire). Exercise capacity will be assessed using the incremental shuttle walking test (ISWT) and physical function will be assessed using the 5x sit to stand test. Physical activity levels will be measured using the ActiGraph wGT3x-BT; participants will be asked to wear the device for 7 consecutive days during waking hours and removed during water-based activities. |
| Intervention type | Other |
| Primary outcome measure | Assessed at the research visit which is scheduled to occur only once: 1. Exercise capacity measured by the ISWT and lung function assessed through spirometry 2. Nutritional and dietary status assessed using measures of height, weight, body composition (bioelectrical impedance), mid-upper arm circumference and 7-day diet diary 3. Physical activity levels measured using accelerometers |
| Secondary outcome measures | Assessed at the research visit which is scheduled to occur only once: 1. Anxiety and depression level measured using Hospital Anxiety and Depression Scale (HADS) 2. Breathlessness measured using Medical Research Council (MRC) Dyspnea scale 3. Health status measured using COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ) 4. Economic impact measured using Work Productivity and Activity impairment (WPAI) Questionnaire 5. Strength, measured by 5x sit-to-stand test |
| Overall study start date | 01/04/2018 |
| Completion date | 01/05/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 patients |
| Key inclusion criteria | Patients: 1. Aged ≥18 years 2. Physician diagnosis of COPD 3. Spirometry confirmed COPD, based on GOLD criteria, with FEV1/FVC <0.7, and FEV1<80% predicted 4. Medical Research Council (MRC) dyspnoea score grade 2 or higher Healthy controls: 1. Aged ≥18 years 2. No physician diagnosis of chronic respiratory disease |
| Key exclusion criteria | 1. Co-morbidities such as severe or unstable cardiovascular, other internal diseases and locomotor difficulties that preclude exercise 2. Malignant disease or other serious illness which will interfere with participation in the PR programme 3. Unable or unwilling to provide informed consent |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 28/02/2022 |
Locations
Countries of recruitment
- Sri Lanka
Study participating centre
Colombo
Sri Lanka
Sri Lanka
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 (0)1162522522 |
|---|---|
| smd8@leicester.ac.uk | |
| Website | https://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 | 31/01/2024 |
|---|---|
| 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 | It is anticipated the results and protocol will be published in open-access peer-reviewed journals and disseminated to commissioners, service managers, service users and service providers. We anticipate the findings will also be presented at international conferences. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
06/02/2023: The overall end date was changed from 01/02/2023 to 01/05/2023.
28/09/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2022 to 01/02/2023.
2. The intention to publish date was changed from 30/09/2023 to 31/01/2024.
3. The plain English summary was updated to reflect these changes.
05/04/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2021 to 30/09/2022.
2. The intention to publish date was changed from 31/03/2021 to 30/09/2023.
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 01/02/2021 to 01/04/2021.
2. The recruitment end date has been changed from 30/11/2021 to 28/02/2022.
27/07/2020: The recruitment start date was changed from 01/05/2020 to 01/02/2021.
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 target number of participants was changed from '150 patients and 30 healthy controls' to '150 patients'.
2. The recruitment start date was changed from 30/11/2019 to 01/05/2020.
3. The recruitment end date was changed from 30/09/2020 to 30/11/2021.
02/09/2019: Trial's existence confirmed by the NIHR.
