Condition category
Respiratory
Date applied
07/10/2015
Date assigned
21/10/2015
Last edited
21/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In developing countries, long-term conditions which affect the lungs (chronic lung disease) and the airways are a growing problem. Infections which affect the lungs such as tuberculosis (TB) and HIV, along with tobacco smoking and unhealthy diet mean that around one in five adults in Africa suffer from chronic lung disease (CLD). People with CLD are likely to experience breathlessness and chest pain, especially when exerting themselves, and so sufferers tend to avoid exercise. This can lead to their lung conditions getting worse, causing disability that is both a source of suffering and strain on the health services. Medication can be used to help improve the symptoms of CLD however it does not stop the disease from getting worse in the long term. Many studies have shown that regular exercise can help to strengthen and tone the lungs so that they are able to take in more oxygen (increased lung capacity). The pulmonary rehabilitation (PR) programme has been designed to encourage people suffering from CLD to exercise and to educate them about how to best manage their condition. The PR is an inexpensive way of supporting patients to help each other and themselves, by using local health workers such as nurses, doctors, physiotherapists and clinic staff. The aim of this study is to find out whether the PR programme is an effective way to help people with CLD in Uganda, and whether it would be appropriate to organise a larger trial to test its benefits across East Africa.

Who can participate?
Adults who have been diagnosed with COPD or TB and are treated at Mulago Hospital (Uganda).

What does the study involve?
Participants are invited to take part in a pulmonary rehabilitation programme twice a week for six weeks. The programme involves a combination of exercises which are designed to improve strength, stamina and general fitness, and education sessions designed to teach about respiratory (breathing) diseases, why exercise is important and relaxation techniques. After the six week programme, and then again after a further six weeks, participants attend a follow-up appointment in which their general health is assessed by testing how they perform in physical tests. Participants are also interviewed and asked to complete a number of questionnaires in order to find out if their quality of life has improved since taking part in the pulmonary rehabilitation programme.

What are the possible benefits and risks of participating?
A potential benefit is that taking part in this study will encourage patients to become more active rather than taking medications. This could help to improve their quality of life by improving symptoms such as chest pain, coughing up blood and night sweats. There are no risks of taking part in this study.

Where is the study run from?
Mulago Hospital (Uganda)

When is the study starting and how long is it expected to run for?
April 2015 to March 2016

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Dr Ruper Jones
Rupert.jones@plymouth.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rupert Jones

ORCID ID

http://orcid.org/0000-0002-5463-2981

Contact details

Plymouth University
Peninsula Schools of Medicine and Dentistry
Room N16
ITTC Building
Research Way
Plymouth
PL6 8BU
United Kingdom
+44 1752 434258
rupert.jones@plymouth.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A development study to examine feasibility and acceptability of pulmonary rehabilitation in Uganda for adults with chronic respiratory disease

Acronym

Study hypothesis

Pulmonary rehabilitation in Uganda for adults with chronic respiratory disease is feasible and acceptable.

Ethics approval

Mulago Research Ethics Committee, 19/03/2015, ref: MREC 440

Study design

Single-centre mixed-methods feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic Lung Disease

Intervention

This is a non-randomised feasibility study. Patients who fulfill the inclusion criteria will be invited to take part in a pulmonary rehabilitation programme (intervention) twice a week for six weeks, with follow-up at the end of the six week intervention and also six weeks after completion of the intervention. Follow-up includes data collection but no further intervention.

Pulmonary rehabilitation consists of a programme of exercises and health education, of one hour duration each . These take place on the same day, at Mulago Hospital, Kampala twice a week for six weeks. Each programme comprises 10-12 participants who fulfill the study eligibility criteria and have completed Baseline Assessment. During the PR programme each participant will be taken through a range of exercises supervised by a physiotherapist, and health education delivered by a physiotherapist and physician (see below).

Exercise programme
1. Includes resistance training (e.g. weights used for upper and lower limbs) and aerobic training: biceps Curl; sit to stand; pull ups; step ups; cycling and walking
2. Equipment – minimal for exercise so can be continued at home (e.g. weights are bottles filled with water)
3. Regime individually prescribed, monitored and increased as programme progresses

Education sessions
1. Causes of breathless (breathlessness is not harmful)
2. Coping and relaxation techniques
3. Role of exercise in building up strength and endurance
4. Effects of TB on lungs specifically and body in general
5. Treatment for TB
6. Pacing and activities of daily living
7. Cigarettes smoking and exposure to biomass smoke
8. Nutrition healthy eating
9. Chest infections and what to do if they get worse
10. HIV
11. What help and support is available
12. Maintaining the gains

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The feasibility and acceptability of pulmonary rehabilitation programme is determined at baseline, 6 weeks (end of intervention) and 12 weeks (6 weeks after intervention completion) using the following measures:
1. Walking distance measured using the Incremental Shuttle Walking Test
2. Quality of life measured using the disease specific Clinical COPD and EQ-5D questionnaires
3. Breathlessness measured using the MRC Dyspnoea Scale, Spirometry, Oximetry and Biometrics
4. Functional ability measured using the Karnofsky Scale, Borg Score and sit to stand time
5. Participant experience measured using ethnographic observations, individual interviews and focus groups at baseline, during the pulmonary rehabilitation intervention and 12 weeks (6 weeks after intervention completion)

Secondary outcome measures

1. Chest pain is measured using a subset of questions from the Brief Pain Inventory at baseline, 6 weeks (end of intervention) and 12 weeks (6 weeks after intervention completion)
2. Haemoptysis is measured using a single question rating scale at baseline, 6 weeks (end of intervention) and 12 weeks (6 weeks after intervention completion)
3. Depression is measured using the PHQ-9 all measured at baseline, 6 weeks (end of intervention) and 12 weeks (6 weeks after intervention completion)

Overall trial start date

24/04/2015

Overall trial end date

01/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Diagnosis of chronic obstructive pulmonary disease (COPD) or tuberculosis (TB)
3. Seen at Mulago Hospital as an inpatient or outpatient
4. Medical Research Council dyspnoea score grade 2 (MRC2) or higher
5. No unstable cardiovascular disease or locomotor difficulties that preclude exercise

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30-40

Participant exclusion criteria

1. Smear positive TB for those with previous TB treatment
2. Unwilling or unable to attend a PR programme
3. Unable to provide informed consent.

Recruitment start date

24/04/2015

Recruitment end date

10/11/2015

Locations

Countries of recruitment

Uganda

Trial participating centre

Mulago Hospital
Mulago Hill
Kampala
P.O.Box 7051
Uganda

Sponsor information

Organisation

Plymouth University, Peninsula Schools of Medicine and Dentistry

Sponsor details

Plymouth University
Peninsula Schools of Medicine and Dentistry
Room N16
ITTC Building
Research Way
Plymouth
PL6 8BU
United Kingdom
+44 1752 434258
rupert.jones@plymouth.ac.uk

Sponsor type

University/education

Website

https://www.plymouth.ac.uk/your-university/about-us/university-structure/faculties/medicine-dentistry

Funders

Funder type

Research organisation

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Department for International Development

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of the feasibility development trial will be presented to local and national educational meetings in Africa and international conferences including the European Respiratory Society, International Union against TB and Lung Disease and the IPCRG (who have agreed for an oral presentation on this research at their 2016 conference. Papers will be submitted to peer reviewed open access journals and other high impact peer review journals (for example, Lancet Global Health).
A project website will be created and updated monthly on the University of Plymouth server, with links to other web platforms and social media. The website will be referred to in all project dissemination activities. Educational videos for lay people will be uploaded on the Plymouth and IPCRG websites, with free access to educational resources developed during the project.A press release will be developed with the assistance of the Plymouth University’s press office. Local and national media campaigns will be used in Africa, particularly focussing on radio and television broadcasts.

Intention to publish date

31/08/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes