Chronic respiratory disease Respiratory Respiratory disorder, unspecified
Conditions
Interventions
This study is a parallel, two-group, assessor- and statistician-blinded, randomised trial. The method of randomisation is minimisation. Consenting participants will be randomised at the individual lev
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/03/2019: 1. Age range: 18 years and over (updated 02/08/2018) 2. Gender: male and female 3. Physician diagnosis of stable chronic respiratory disease, typically COPD, interstitial lung disease, bronchiectasis, chronic asthma or chest wall disease (updated 27/03/2019) 4. Referred for PR in line with British Thoracic Society guidelines (i.e. ambulatory – can walk =5 metres, functional impairment related to breathlessness, typically MRC dyspnoea score =2) 5. Able to communicate verbally and respond to questions in written English _____ Previous inclusion criteria: 1. Age range: 18 to 100 years 2. Gender: male and female 3. Physician diagnosis of stable chronic respiratory disease, typically COPD, interstitial lung disease, bronchiectasis, chronic asthma or chest wall disease with no change in medication in past 6 weeks 4. Referred for PR in line with British Thoracic Society guidelines (i.e. ambulatory – can walk =5 metres, functional impairment related to breathlessness, typically MRC dyspnoea score =2) 5. Able to communicate verbally and respond to questions in written English
Exclusion criteria
Exclusion criteria: 1. Contra-indication to moderate intensity physical exercise e.g. unstable cardiovascular disease 2. Progressive cancer or neurological disorder with expected life expectancy less than 12 months 3. Completed PR within previous 12 months 4. Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exercise capacity measured by the incremental shuttle walk test distance at baseline and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breathlessness measured using the Chronic Respiratory Questionnaire (CRQ) – dyspnoea domain at baseline, 8 weeks and 12 months 2. Disease-specific health-related quality of life measured using the CRQ at baseline, 8 weeks and 12 months 3. Lower limb muscle strength measured using isometric quadriceps maximum voluntary contraction at baseline, 8 weeks and 12 months 4. Trial process details: number of patients recruited to the trial; proportion of patients that uptake, adhere to and complete PR; reasons for PR non-completion and proportions of patients satisfaction levels on the GROC. This information will be collected in each arm of the study, at the appropriate stage of the trial e.g. baseline, 8 weeks and 12 months 5. The cost and cost-effectiveness of the intervention from the perspective of the NHS using the Modified Service Receipt Inventory, quality-adjusted life years using the Euro-Qol 5 Dimensions 5 Levels questionnaire utility index and healthcare resource usage data obtained from NHS Digital at baseline and 12 months Amended 06/07/2018: last timepoint corrected from 14 months to 12 months. | — |
Countries
England, United Kingdom
Outcome results
None listed