Feasibility and acceptability of pulmonary rehabilitation for people with chronic lung diseases in Malawi

Protocol for a single-centre mixed-methods pre-post single-arm feasibility trial of a culturally appropriate six-week pulmonary rehabilitation programme among adults with functionally limiting chronic respiratory diseases in Malawi

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13836793

Enrollment

Registered

2021-08-27

Start date

2021-10-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults with functionally limiting chronic respiratory diseases in Malawi Respiratory

Interventions

This is a single-centre mixed-methods pre-post single-arm feasibility trial of a culturally appropriate six-week pulmonary rehabilitation (PR) programme among adults with functionally limiting chronic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Those aged 18 years or older 2. Those with a spirometry confirmed diagnosis of chronic respiratory disease (CRD) 3. Those with functional limitation due to breathlessness reaching a score of =2 on the modified Medical Research Council (mMRC) dyspnoea scale

Exclusion criteria

Exclusion criteria: 1. Those with significant cardiovascular, neurological, orthopaedic, cognitive, or any other condition that would compromise participation in the rehabilitation programme 2. Those with an active infection including tuberculosis (TB) and coronavirus disease 2019 (COVID-19) 3. Those with respiratory disease which is thought primarily to originate from recent COVID-19 infection 4. Those unable to provide informed consent

Design outcomes

Primary

Measure	Time frame
1. Input for a culturally appropriate pulmonary rehabilitation (PR) programme collected through semi-structured in-depth interviews at baseline (at week 0) 2. Participants' acceptability of the PR programme explored through semi-structured in-depth interviews at the end of the programme duration (at week 6)	—

Secondary

Measure	Time frame
1. Lung function (pre- and post-bronchodilator forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio) measured using spirometry at both baseline (at week 0) and end of the trial (at week 6) 2. Health status variables such as participants’ perceived respiratory disability due to dyspnoea (using the modified Medical Research Council (mMRC) dyspnoea scale), health-related quality of life (using the chronic obstructive pulmonary disease assessment test (CAT)), subjective experience of fatigue (using the Checklist Individual Strength fatigue subscale (CIS-Fatigue)), and emotional health (using the Hospital Anxiety and Depression Scale (HADS)), at both baseline (at week 0) and end of the trial (at week 6) 3. Physical fitness variables such as exercise tolerance (using the incremental shuttle walk test (ISWT)), lower extremity muscular strength using five-repetition sit-to-stand test (5XSST) and hamstring flexibility measured using the chair sit-and-reach (CSR) test, at both baseline (at week 0) and end of the trial (at week 6)	—

Measure

Time frame

1. Lung function (pre- and post-bronchodilator forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio) measured using spirometry at both baseline (at week 0) and end of the trial (at week 6) 2. Health status variables such as participants’ perceived respiratory disability due to dyspnoea (using the modified Medical Research Council (mMRC) dyspnoea scale), health-related quality of life (using the chronic obstructive pulmonary disease assessment test (CAT)), subjective experience of fatigue (using the Checklist Individual Strength fatigue subscale (CIS-Fatigue)), and emotional health (using the Hospital Anxiety and Depression Scale (HADS)), at both baseline (at week 0) and end of the trial (at week 6) 3. Physical fitness variables such as exercise tolerance (using the incremental shuttle walk test (ISWT)), lower extremity muscular strength using five-repetition sit-to-stand test (5XSST) and hamstring flexibility measured using the chair sit-and-reach (CSR) test, at both baseline (at week 0) and end of the trial (at week 6)

—

Countries

Malawi

Contacts

Public ContactFanuel Bickton

fbickton@mlw.mw+265 882 63 06 94

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026