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
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

https://le.ac.uk/

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

Publication citations

Additional files

Editorial Notes

02/09/2019: Trial's existence confirmed by the NIHR.