Is pulmonary rehabilitation possible for patients with chronic obstructive pulmonary disease in a low resource setting in Jaffna, Sri Lanka?

ISRCTN	ISRCTN10069208
DOI	https://doi.org/10.1186/ISRCTN10069208

Submission date: 05/03/2021
Registration date: 16/04/2021
Last edited: 06/05/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name for a group of lung conditions that cause breathing difficulties.
The burden of Chronic Obstructive Pulmonary Disease (COPD) has been increasing worldwide over the last few decades. It is a major cause of illness and death. According to the World Health Organization, 5% of global deaths in 2015 were due to COPD.
COPD increases the risk for other diseases and has effects like weight loss, nutritional abnormalities and muscle problems. In addition, decreased exercise performance, low physical activity and, impaired quality of life are adverse effects.
International guidelines for the management of COPD strongly recommend Pulmonary Rehabilitation (PR), which involves exercise and education at its core. At the moment there are no formal PR services in Sri Lanka, as with many low resources settings with limited facilities or expertise to conduct PR. Hence, this study aimed to implement a PR program in a low resource setting and to find out if it is feasible to deliver a trial of PR for people living with COPD in Jaffna, Sri Lanka.

Who can participate?
Adult patients with COPD.

What does the study involve?
Participants either had treatment as usual or a six-week programme, with sessions occurring twice weekly with approximately one hour for education and one hour for exercise.

What are the possible benefits and risks of participating?
None

Where is the study run from?
University of Jaffna (Sri Lanka)

When is the study starting and how long is it expected to run for?
June 2019 to March 2020

Who is funding the study?
1. University of Jaffna (Sri Lanka)
2. The National Institute for Health Research (UK).

Who is the main contact?
Dr Mathanki Sooriyakanthan, smathanki@univ.jfn.ac.lk

Contact information

Dr Mathanki Sooriyakanthan
Public

Department of Physiology
Faculty of Medicine
University of Jaffna
Jaffna
-
Sri Lanka

ORCID ID	0000-0002-1970-9517
Phone	+94 (0)2122222073
Email	smathanki@univ.jfn.ac.lk

Dr Mathanki Sooruyakanthan
Scientific

Department of Physiology
Faculty of Medicine
University of Jaffna
Jaffna
-
Sri Lanka

ORCID ID	0000-0002-1970-9517
Phone	+94 (0)2122222073
Email	smathanki@univ.jfn.ac.lk

Study information

Study design	Interventional non-randomized
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Community
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Feasibility trial of pulmonary rehabilitation on patients with Chronic Obstructive Pulmonary Disease in a low resource setting in Jaffna, Sri Lanka
Study objectives	It will be feasible to conduct a trial of pulmonary rehabilitation in a low resource setting for people living with COPD.
Ethics approval(s)	Approved 23/05/2019, Faculty of Medical Sciences REC (University of Sri Jayewardenepura, Sri Lanka; +94-11-2758588; erc.fms.usjp@gmail.com), ref: 35/18
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease
Intervention	The intervention (Pulmonary Rehabilitation) consisted of a six-week programme, with sessions occurring twice weekly with approximately one hour for education and one hour for exercise. Pulmonary Rehabilitation was provided by the trained investigator and assisted by other staff at the department. The education component was focused on exercise, diet, disease education, medication, managing breathlessness, chest clearance, relaxation, energy conservation and avoidance of exacerbations. Pulmonary Rehabilitation was provided in groups of up to 6 COPD patients. The exercise program consisted of stretching, aerobic and strength training exercises, using minimal equipment, individually adjusted over the course of six weeks. The aerobic exercise was 30 minutes of continuous walking. Strength training exercises consisted of bicep curls, pull ups, sitting to standing and step ups. Each of these strength training exercises were performed with hand weights. The participants in the control arm received usual pharmacotherapy alone.
Intervention type	Behavioural
Primary outcome measure	Feasibility measures including: 1. Suitability of inclusion criteria measured using the reasons for not being eligible, reasons for declining, reasons for not completing the exercise program by 9 months 2. Refusal rate measured using number of eligible patients identified and number of patients consented to participate in the study by 9 months 3. Uptake and completion of the study measured number of patients enrolled into the study and number of patients completed 6 weeks program during 9 months 4. Compliance to PR sessions measured using number of patients enrolled in PR sessions and number completed 6 weeks program including post assessment during 9 months 5. Adherence to home exercise assessed via a self-report exercise diary assessed via a self-report exercise diary for 6 weeks
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. Lung health, assessed by spirometry 5. Exercise capacity, measured by Incremental Shuttle Walk Test (ISWT) and Six Minute Walk Test (6MWT)
Overall study start date	10/06/2019
Completion date	13/03/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50-60
Total final enrolment	54
Key inclusion criteria	Physician diagnosis of COPD based on symptoms and spirometry confirmed based on GOLD criteria, with FEV1/FVC <0.7, and FEV1<80% predicted.
Key exclusion criteria	1. Unable or unwilling to provide informed consent 2. Comorbidities such as severe or unstable cardiovascular disease or other lung diseases 3. Stroke, Peripheral neuropathies or any other internal diseases and locomotor difficulties that limit the exercise performance 4. Significant hearing impairment
Date of first enrolment	15/06/2019
Date of final enrolment	10/03/2020

Locations

Countries of recruitment

Sri Lanka

Study participating centre

Department of Physiology

Faculty of Medicine
University of Jaffna
Jaffna
-
Sri Lanka

Sponsor information

University of Jaffna
Government

Faculty of Medicine
Adiyapatham Road
Kokuvil
Jaffna
-
Sri Lanka

Phone	+94 (0)212222073
Email	deanmedicine@univ.jfn.ac.lk
Website	http://www.jfn.ac.lk/
"ROR"	https://ror.org/02fwjgw17

Funders

Funder type

University/education

University of Jaffna
Government organisation / Local government

Alternative name(s): UoJ
Location: Sri Lanka

National Institute for Health Research
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	30/04/2022
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	The researchers will publish the results from this study 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 plan	The current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		08/08/2022	09/08/2022	Yes	No
Results article		28/02/2025	06/05/2025	Yes	No

Editorial Notes

06/05/2025: Publication reference added.
09/08/2022: Publication reference added.
07/02/2022: The study design was changed from "Interventional randomized controlled trial" to "Interventional non-randomized".
01/02/2022: The intention to publish date has been changed from 30/01/2022 to 30/04/2022.
18/08/2021: The following changes have been made:
1. The study design has been changed from "Interventional non-randomized controlled trial" to "Interventional randomized controlled trial".
2. The secondary study design has been changed from "Non-randomised study" to "Randomised controlled trial".
3. The target number of participants has been changed from 40 to 50-60.
4. The total final enrolment has been changed from 40 to 54.
5. The NIHR has been added as a funder in the plain English summary.
6. The intention to publish date has been changed from 30/08/2021 to 30/01/2022.
08/03/2021: Trial's existence confirmed by Faculty of Medical Sciences, University of Sri Jayewardenepura.