Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

January 10, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

July 31, 2026

Conditions
Chronic Obstructive Pulmonary Disease
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)."

Trial Locations (7)

2100

RECRUITING

Municipality of Copenhagen, Copenhagen

2300

RECRUITING

Copenhagen University Hospital Amager, Copenhagen

2400

RECRUITING

Copenhagen University Hospital Bispebjerg-Frederiksberg, Copenhagen

2650

RECRUITING

Copenhagen University Hospital Hvidovre, Hvidovre

2820

RECRUITING

Copenhagen University Hospital Herlve-Gentofte, Gentofte Municipality

3400

RECRUITING

Copenhagen University Hospital Nordsjaelland, Hillerød

3700

RECRUITING

Bornholms Hospital, Rønne

All Listed Sponsors
collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

collaborator

Hillerod Hospital, Denmark

OTHER

collaborator

Herlev and Gentofte Hospital

OTHER

lead

Copenhagen University Hospital, Hvidovre

OTHER