A study to explore whether pulmonary rehabilitation in Uganda for adults with chronic respiratory disease is practical and acceptable to patients

• Register: ISRCTN
• Last refreshed on: 20 November 2023
• Main ID: ISRCTN14312425
• Date of registration: 21/10/2015
• Prospective Registration: No
• Primary sponsor: Plymouth University, Peninsula Schools of Medicine and Dentistry
• Public title: A study to explore whether pulmonary rehabilitation in Uganda for adults with chronic respiratory disease is practical and acceptable to patients
• Scientific title: A development study to examine feasibility and acceptability of pulmonary rehabilitation in Uganda for adults with chronic respiratory disease
• Date of first enrolment: 24/04/2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14312425
• Study type: Interventional
• Study design: Single-centre mixed-methods feasibility study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Uganda

Contacts

• Name: Rupert Jones

Key inclusion & exclusion criteria

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

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.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Lung Disease
Respiratory
Chronic Lung Disease

Intervention(s)

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.

Primary Outcome(s)

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(s)

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)

Secondary ID(s)

N/A

Nil known

Source(s) of Monetary Support

Wellcome Trust, Medical Research Council, Department for International Development

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Mulago Research Ethics Committee, 19/03/2015, ref: MREC 440

Results

• Results available: Yes
• Date Completed: 01/03/2016