Skip to content

Pulmonary rehabilitation in low resource settings for people with breathlessness due to lung conditions.

Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind randomised implementation trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076952
Enrollment
465
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: J410- Simple chronic bronchitis Health Condition 2: J411- Mucopurulent chronic bronchitis Health Condition 3: J418- Mixed simple and mucopurulent chronic bronchitis Health Condition 4: J42- Unspecified chronic bronchitis Health Condition 5: J439- Emphysema, unspecified Health Condition 6: J441- Chronic obstructive pulmonary disease with (acute) exacerbation Health Condition 7: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 8: J459- Other and unspeci

Interventions

Intervention1: Centre-based Pulmonary Rehabilitation: Centre-based Pulmonary Rehabilitation (PR) will be delivered in groups (compliant with any social distancing requirements)
in single sex groups, where it is culturally appropriate. These sessions will be supervised by the therapist and will last up to two hours and include exercise components and group education. These su

Sponsors

Medical Research Council UK Applied Global Health Research Board
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Assessed by referring physician as having persistent and functionally limiting respiratory symptoms (mMRC =2) after optimization of pharmacological therapy. 2. Resident locally and willing to engage with either Centre-PR and Home-PR schedules if randomized to either of these groups. 3. Willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1) People with non-respiratory causes for the symptoms (stable co-morbidity may be included if clinically appropriate). 2) Active TB infection. 3) Any condition that would increase risk (e.g. uncontrolled cardiac disease) interfere with PR (e.g. neurological disorders, severe arthritis, dementia) or be inappropriate (very severe frailty, end-of-life) 4) On-going, or completed PR (including other exercise program) within previous 18 months. 5) Living in the same house as another participant. 6) Unwilling or unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
1.Exercise capacity measured by the Endurance Shuttle Walking Test (ESWT) assessed post-PR intervention period. 2.HRQoL will be measured with the 50-item St Georges Respiratory Questionnaire (SGRQ). 3.Breathless will be assessed with the modified MRC Dyspnoea Scale (mMRC) ranging from 0-4. 4.The common co-morbid symptoms of anxiety and depression will be assessed with the Hospital Anxiety and Depression Score (HADS). 5.The impact of breathlessness on activities of daily living such as washing and dressing will be assessed with the London Chest Activities of Daily Living (LCADL). 6.The Global Physical Activity Questionnaire (GPAQ) assesses physical activity in the domains of work, leisure, or travel.Timepoint: 1. Baseline before randomization (T0) 2. At 12 weeks after completion of PR intervention (T+12; between 10-14 weeks) 3. At 6 months following intervention (T+26; between 24-30 weeks)

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

Bangladesh, India, Malaysia

Contacts

Public ContactMr Paul Jebaraj

Christian Medical College, Vellore

drbpaul@cmcvellore.ac.in8124034755

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026