Plain English Summary
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 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
+44 (0)1162583113
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
+44 (0)1162583113
mwo4@leicester.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Version 1
Study information
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
Acronym
Global RECHARGE Sri Lanka
Study hypothesis
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
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)
Study design
Single-centre observational (cross sectional) study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
01/04/2018
Overall trial end date
31/03/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
150 patients and 30 healthy controls
Participant 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
Recruitment start date
30/11/2019
Recruitment end date
30/09/2020
Locations
Countries of recruitment
Sri Lanka
Trial participating centre
Central Chest Clinic
Dr Danister De Silva Mawatha
Colombo
Sri Lanka
Sri Lanka
Sponsor information
Organisation
University of Leicester
Sponsor details
University Road
Leicester
LE1 7RH
United Kingdom
+44 (0)1162522522
smd8@leicester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
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 statement
The data sharing plans for the current study are unknown and will be made 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