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
Chronic lung disease in low- and middle-income countries (LMICs) is associated with fumes from cooking on open stoves, air pollution and infections such as tuberculosis (TB). Chronic lung disease usually affects the most vulnerable people in developing countries, where people are unable to work from a younger age, and therefore increases the burden of the disability in LMICs. Sufferers are frequently disabled by their breathlessness. As a result, the individual experiences a reduced ability to perform daily activities, poor quality of life and social isolation. The disease is characterised by sudden flare-ups of symptoms, known as acute exacerbations, when symptoms become severe and the level of disability increases. Furthermore, medication in developing countries remains largely unavailable, expensive, and does not reverse the disability caused by chronic lung disease. Pulmonary rehabilitation is a non-drug, low cost, high impact intervention that reverses the disability associated with chronic lung disease. It brings together health professionals from many disciplines, offering supervised exercise training and disease education. However, pulmonary rehabilitation is largely unavailable in developing countries like Sri Lanka and this study seeks to fill this gap and address the unmet needs. The aim of this study is to develop and assess the feasibility and acceptability of a culturally appropriate hospital-based pulmonary rehabilitation service in Sri Lanka.

Who can participate?
Patients aged 18 and over with COPD

What does the study involve?
Participants are randomly allocated to either a pulmonary rehabilitation group or a control group (usual care). The pulmonary rehabilitation programme consists of 6 weeks of disease-related education and exercises conducted twice weekly. Participants are encouraged to undertake exercise whilst at home too. Participants are asked to attend an appointment at the time of entry into the study (baseline) and at the end of the programme (6 weeks).

What are the possible benefits and risks of participating?
Pulmonary rehabilitation is not routinely available in Sri Lanka. It is envisaged that participants will benefit from taking part in the intervention. Benefits may include improved fitness and reduced severity of symptoms such as breathlessness or chest tightness. There are no anticipated risks of participating.

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

Assess the feasibility and acceptability of a hospital based Pulmonary Rehabilitation programme incorporating dancing for people with COPD in Colombo district in Sri Lanka: Global RECHARGE Sri Lanka

Acronym

Global RECHARGE Sri Lanka

Study hypothesis

1. To determine the feasibility and the acceptability of a culturally adapted Pulmonary Rehabilitation programme specific to Sri Lanka using opinions from patients and health care professionals on aspects of nutrition including nutritional assessments, outcome measures, education components and aspects of an exercise intervention incorporating music and dance relevant to patients in Sri Lanka
2. To develop a culturally adapted hospital-based Pulmonary Rehabilitation programme that is feasible and acceptable according to patients and healthcare staff

Ethics approval

Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka & University of Leicester, UK (anticipated submission August 2019)

Study design

Single-centre qualitative study and feasibility randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Chronic obstructive pulmonary disease

Intervention

This trial will consist of a mixed-methods approach and recruitment for each stage will be separate. The trial consists of two stages:

1. Focus groups will be conducted with adults with a diagnosis of COPD and interviews will be conducted with potential referrers to pulmonary rehabilitation (healthcare staff) and singing and dancing experts

2. A feasibility RCT of Pulmonary Rehabilitation versus usual care (control). Participants will be individually randomised (1:1) to the Pulmonary Rehabilitation programme or to the control group (usual care). Due to the nature of pulmonary rehabilitation, it will not be possible for patients to be blinded to the allocation. All measures will be taken by a blinded assessor.

The intervention (Pulmonary Rehabilitation) will consist of a six-week programme, with sessions occurring twice weekly for at least two hours with approximately one hour for education and one hour for exercise. Pulmonary Rehabilitation will be provided by a team of respiratory doctors, physiotherapists, nurses and singing/dancing experts. The education component will focus on causes of breathlessness, coping techniques, the role of smoking, biomass smoke, TB and HIV and the value of exercise. Information regards the importance of nutrition will be included in the education sessions; the content will be largely guided by the focus groups in stage 1.

The exercises will be guided by the data collected in the interviews and focus groups (stage 1). The exercise component consists of a combination of resistance and aerobic training, using minimal equipment, individually adjusted over the course of six weeks. Pulmonary Rehabilitation will be provided in groups of up to 10 people with COPD. The exercise regime will be individually prescribed to participants based on their exercise capacity. The regime is based on international guidance and will consist of the following:
1. Stretching/flexibility exercises
2. Resistance training for upper and lower limbs including sit to stand, step ups, bicep curls and pull ups
3. Endurance exercise included walking and cycling on a stationary bike.

The content of the programme will also likely include culturally appropriate activities, such as singing and dancing. These will be guided by the data gathered in stage 1.

The participants in the control arm will receive usual medical care. All participants, regardless of study arm, will receive the "Living with COPD: 5 steps to better lung health" brochure. This is an educational booklet containing information about lung health.

Patient focus groups
Participants allocated to the intervention group will be invited to participate in focus group discussions at the end of their Pulmonary Rehabilitation programme to learn about their experience of Pulmonary Rehabilitation. Focus groups will give an insight on views, experiences, opinions and recommendations which will be then helpful to inform design of future PR programmes. We anticipate conducting up to 6 focus groups with 2-10 participants in each. We will invite participants from the intervention group who completed the Pulmonary Rehabilitation programme and who dropped out of Pulmonary Rehabilitation to understand their experiences of the intervention. Focus group discussions will be audio-recorded, each lasting approximately 45-60 minutes, and will be conducted face-to-face by an interviewer and note taker (observer). Focus groups will be transcribed verbatim, with identifiable information removed.

Staff interviews
Health care personnel involved in Pulmonary Rehabilitation will be invited to participate in interviews at the end of study to discuss aspects of feasibility and acceptability, such as insights into barriers and facilitators to referral, uptake and completion of Pulmonary Rehabilitation. We anticipate conducting up to 15 interviews. Interviews will be audio-recorded, each lasting approximately 30-45 minutes, and will be conducted face-to-face by an interviewer. Interviews will be transcribed verbatim, with identifiable information removed.

Book of testimonies
Patients attending Pulmonary Rehabilitation will be asked to log their experience of PR as they progress through the programme. This will be in the form of a Pulmonary Rehabilitation log book accessible to patients before, during and after sessions, as well as a dedicated patient evaluation form. Participants will be regularly prompted in order to gain the experiences of as many patients as possible. Patient satisfaction will also be recorded using a survey; staff involved in Pulmonary Rehabilitation will also receive the same evaluation form at the end of the study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Feasibility measures including:
1. Suitability of the inclusion criteria
2. Refusal rate
3. Uptake and completion of the study
4. Willingness of patients to be recruited and the willingness of healthcare professionals to refer to this study and future trials
5. Service provider and multi-disciplinary teams’ willingness and ability to deliver the new PR programme
6. The practicality of delivering the intervention in the proposed setting
7. The time needed to collect and analyse the data
8. Test methods for the collection of data as well as data completeness and accuracy
9. The acceptability of the PR programme, assessed through focus groups
10. Compliance to the PR sessions
11. Adherence to home exercise assessed via a self-report exercise diary
12. The training and resource needed to deliver the intervention (ensuring readiness for a future multi-centre trial)

Secondary outcome measures

Measured at baseline and at 6 weeks post baseline:
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. Nutritional status, measured by body weight using scales, body composition using bioelectrical impedance and skinfold thickness, and 7-day diet diary
6. Lung health, assessed by spirometry, impulse oscillometry and diffusing capacity for carbon monoxide
7. Exercise capacity, measured by incremental shuttle walking test (ISWT) and the endurance shuttle walking test (ESWT)
8. Physical activity, measured by ActiGraph wGT3x-BT accelerometer
9. Physical function, 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

Stage 1 (patient):
1. Aged ≥18 years
2. Physician diagnosis of COPD

Stage 1 (staff):
1. Healthcare staff that would typically refer patients to a clinical PR programme, such as physicians & clinicians.

Stage 2:
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

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Stage 1: up to 15 members of staff and up to 40 patients but this will be impacted by data saturation. Stage 2: As this is a feasibility trial, no formal sample size is required, yet we hope to recruit 50 patients

Participant exclusion criteria

Stage 1 (patients):
1. Unable or unwilling to provide informed consent

Stage 2 (staff):
1. Unable or unwilling to provide informed consent

Stage 2:
1. Comorbidities 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 Pulmonary Rehabilitation programme
3. Unable or unwilling to provide informed consent

Recruitment start date

31/03/2020

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)116 252 2522
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

The researchers will publish a protocol paper for this study. 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 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

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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