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ACTIVE NOT RECRUITING
NCT05664945
NA

Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial

Sponsor: Copenhagen University Hospital, Hvidovre

View on ClinicalTrials.gov

Summary

Pulmonary rehabilitation (PR) is one of the cornerstones of care for people with COPD together with smoking cessation and medical treatment. Despite the compelling evidence for its benefits, pulmonary rehabilitation is delivered to less than 30% of patients with COPD. Access to PR are particularly challenging, and especially for those with the most progressed stages of the disease. Pulmonary Tele-rehabilitation (PTR) and Home-based pulmonary rehabilitation (HPR) are two emerging models using health-care supportive technology that have proven equivalent to the conventional PR programs in patients with COPD who are able and willing to participate in conventional PR. However, much remain unknown regarding patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation. No studies have been conducted to specifically intervene towards this group. Response from emerging rehabilitation models for this specific group is a black box with no substantial research. To fulfill its potential of relevance, results from emerging models, such as Pulmonary Telerehabilitation and Home-based pulmonary rehabilitation must be of clinical relevance, and superior to the current 'usual care' (medication and scheduled follow-up control) in patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation.

Official title: Rethinking Pulmonary Rehabilitation for Patients With COPD: a Three-arm Randomised Multicentre Trial (REPORT-trial)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2023-01-10

Completion Date

2027-07-31

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

BEHAVIORAL

pulmonary tele-rehabilitation (PTR)

PTR is delivered from promoter hospital to a group of 4-6 patients who exercise at home and communicate via tablet-camera. Each session is 60 min; 35 min exercise/ 25 min patient education, two times per week for a duration of 10-weeks (primary endpoint). Specific exercises are evidence-based; been used in several intervention studies on patients with COPD. Exercises involves larger muscle groups with 50/50 exercises for upper and lower extremities. Volume, intensity and content exercise protocol follow both national and international exercise recommendations. The education sessions consist of dialogue, reflections around empowerment and better living with COPD. Every fourth education session consists of 25 min Mindfulness exercises developed for COPD patients. After 10-weeks of PTR, participants are offered once weekly PTR for 60min in groups of 4-8 persons throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).

BEHAVIORAL

home-based pulmonary rehabilitation (HPR)

HPR is an individual self-initiated home-based PR aiming to achieve 20 min of self-initiated muscle-endurance based exercise; 3-days/weekly for 10-weeks (primary endpoint). Exercises are evidence-based; used in several intervention studies on patients with COPD and involves larger muscle groups with 50/50 exercises for upper/lower extremities. First session is a home visit by a respiratory physiotherapist. During the visit the physiotherapist and patient establish exercise goals, exercise prescription and provision of mindfulness exercises and educationbook. The home visit is followed by one weekly session for 10-weeks. A menu of topics relevant to COPD and self-management is discussed. A session is delivered from promoter hospital via tablet-camera or telephone call (patients' preference). After 10-weeks of HPR, participants are offered once weekly PTR for 60min in groups of 4-8 persons throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).

BEHAVIORAL

Control

Receive usual care; medication, scheduled follow-up visit and possible phone contact with GP and the outpatient respiratory department. Except for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered. If a patient changes his/her mind and wishes to participate in a conventional hospital- or community-based PR program, it will be granted as this is a highly recommended treatment (e.g. rehabilitation after hospital admitted exacerbation).

Locations (7)

Copenhagen University Hospital Amager

Copenhagen, Greater Copenhagen, Denmark

Copenhagen University Hospital Bispebjerg-Frederiksberg

Copenhagen, Greater Copenhagen, Denmark

Copenhagen University Hospital Herlve-Gentofte

Gentofte Municipality, Greater Copenhagen, Denmark

Copenhagen University Hospital Nordsjaelland

Hillerød, Greater Copenhagen, Denmark

Copenhagen University Hospital Hvidovre

Hvidovre, Greater Copenhagen, Denmark

Municipality of Copenhagen

Copenhagen, Denmark

Bornholms Hospital

Rønne, Denmark