New approaches to pulmonary rehabilitation for COPD patients
Rethinking Pulmonary Rehabilitation for Patients With COPD: a Three-arm Randomised Multicentre Trial (REPORT-trial)
This study is testing if new home-based and online rehabilitation programs can help people with COPD who can’t go to regular rehab feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 7 sites (Copenhagen, Greater Copenhagen and 6 other locations) |
| Trial ID | NCT05664945 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of pulmonary tele-rehabilitation (PTR) and home-based pulmonary rehabilitation (HPR) for patients with Chronic Obstructive Pulmonary Disease (COPD) who cannot access traditional rehabilitation programs. It employs a three-arm randomized controlled trial design, comparing PTR and HPR against a control group receiving no intervention. The primary outcome is respiratory symptom relief measured by the CAT score, with secondary outcomes also assessed. The study aims to determine if these emerging rehabilitation models can provide significant benefits to a previously underserved patient population.
Who should consider this trial
Good fit: Ideal candidates are COPD patients who meet national rehabilitation guidelines but cannot access traditional outpatient rehabilitation.
Not a fit: Patients who have participated in conventional pulmonary rehabilitation in the past 24 months or have significant cognitive or sensory impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve access to effective rehabilitation for COPD patients who are currently unable to participate in conventional programs.
How similar studies have performed: While tele-rehabilitation and home-based models have shown promise in other studies, this specific approach targeting patients unable to access conventional rehabilitation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication for pulmonary rehabilitation according to Danish national guidelines * Unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation * A post-bronchodilator ratio FEV1/FVC \<70% (confirmed physician diagnosis of COPD) * A post-bronchodilator FEV1 \<80% (degree of airway obstruction) corresponding to GOLD grade 2-4 (moderate to very severe) * GOLD group B, C, D corresponding to severe respiratory symptoms and/or frequent acute exacerbations * Able to stand up from a chair (height 44-46cm) and walk 10 meters independently (with or without a walking aid) * Able to lift both arms to a horizontal level with a minimum of 1 kilogram's dumbbells in each hand Exclusion Criteria: * Participation in conventional PR in the past 24 months * Cognitive impairment - unable to follow instructions * Impaired hearing or vision - unable to see or hear instruction from a tablet * Unable to understand and speak Danish * Comorbidities where the exercise content is contraindicated (e.g. treatment for diabetic foot ulcer, active cancer treatment, life expectancy \<12-months)
Where this trial is running
Copenhagen, Greater Copenhagen and 6 other locations
- Copenhagen University Hospital Amager — Copenhagen, Greater Copenhagen, Denmark (Recruiting)
- Copenhagen University Hospital Bispebjerg-Frederiksberg — Copenhagen, Greater Copenhagen, Denmark (Recruiting)
- Copenhagen University Hospital Herlve-Gentofte — Gentofte, Greater Copenhagen, Denmark (Recruiting)
- Copenhagen University Hospital Nordsjaelland — Hillerød, Greater Copenhagen, Denmark (Recruiting)
- Copenhagen University Hospital Hvidovre — Hvidovre, Greater Copenhagen, Denmark (Recruiting)
- Municipality of Copenhagen — Copenhagen, Denmark (Recruiting)
- Bornholms Hospital — Rønne, Denmark (Recruiting)
Study contacts
- Principal investigator: Henrik Hansen, PhD — Dept. of Respiratory Medicine, University Hospital Hvidovre
- Study coordinator: Henrik Hansen, PhD
- Email: henrik.hansen.09@regionh.dk
- Phone: +4528946780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.