Breathe Plus: a trial to test the feasibility of including a comprehensive assessment at the start of lung rehabilitation for people living with chronic obstructive pulmonary disease and frailty

Breathe Plus: Feasibility trial of a comprehensive geriatric assessment for people with chronic obstructive pulmonary disease and frailty starting pulmonary rehabilitation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13051922

Enrollment

Registered

2019-10-08

Start date

2019-11-01

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

People living with chronic obstructive pulmonary disease and frailty Respiratory

Interventions

Participants will be randomly allocated (1:1) to a control group (usual care) or an intervention group (usual care + comprehensive geriatric assessment). Participants will be randomised by minimisatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 50 years or older 2. Physician diagnosis of chronic obstructive pulmonary disease (in line with GOLD criteria) 3. Referred for outpatient pulmonary rehabilitation (in line with BTS guidelines) 4. Rockwood Clinical Frailty Scale score of 5 or more

Exclusion criteria

Exclusion criteria: 1. Lacking mental capacity to provide informed consent 2. Unable to communicate verbally and respond to questions in written English (or unavailability of interpreters to enable this) 3. Currently receiving specialist geriatric services, or has in previous month, or due to in coming month

Design outcomes

Primary

Measure	Time frame
Feasibility outcomes include: 1. Percentage of comprehensive geriatric assessment recommendations that are implemented at 6 months 2. Acceptability of the intervention to patients and staff based on qualitative interviews 3. Percentage screened eligible, and percentage eligible recruited at trial completion 4. Percentage of participants retained at 3 months and at 6 months 5. Percentage of participants where contamination occurs (i.e. control group participants receiving a comprehensive geriatric assessment) at 6 months 6. Percentage of participants where data collection blinding is maintained at 6 months 7. Level of missing data on patient outcome questionnaires at baseline, 3 and 6 months	—

Measure

Time frame

Feasibility outcomes include: 1. Percentage of comprehensive geriatric assessment recommendations that are implemented at 6 months 2. Acceptability of the intervention to patients and staff based on qualitative interviews 3. Percentage screened eligible, and percentage eligible recruited at trial completion 4. Percentage of participants retained at 3 months and at 6 months 5. Percentage of participants where contamination occurs (i.e. control group participants receiving a comprehensive geriatric assessment) at 6 months 6. Percentage of participants where data collection blinding is maintained at 6 months 7. Level of missing data on patient outcome questionnaires at baseline, 3 and 6 months

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Secondary

Measure	Time frame
The following outcomes will be measured at baseline, 3 and 6 months: 1. Physical frailty assessed using short physical performance battery 2. Activities of daily living assessed using Manchester Respiratory Activities of Daily Living questionnaire 3. Health-related quality of life assessed using Chronic Respiratory Questionnaire 4. Health Status assessed using Euro-Qol 5D-5L 5. Anxiety and depression assessed using Hospital Anxiety and Depression Scale 6. Loneliness assessed using De Jong Gierveld Loneliness Scale 7. Service use assessed using Client Service Receipt Inventory	—

Measure

Time frame

The following outcomes will be measured at baseline, 3 and 6 months: 1. Physical frailty assessed using short physical performance battery 2. Activities of daily living assessed using Manchester Respiratory Activities of Daily Living questionnaire 3. Health-related quality of life assessed using Chronic Respiratory Questionnaire 4. Health Status assessed using Euro-Qol 5D-5L 5. Anxiety and depression assessed using Hospital Anxiety and Depression Scale 6. Loneliness assessed using De Jong Gierveld Loneliness Scale 7. Service use assessed using Client Service Receipt Inventory

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026