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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Copenhagen University Hospital Amager
RECRUITING
Copenhagen
Copenhagen University Hospital Bispebjerg-Frederiksberg
RECRUITING
Copenhagen
Municipality of Copenhagen
RECRUITING
Copenhagen
Copenhagen University Hospital Herlve-Gentofte
RECRUITING
Gentofte Municipality
Copenhagen University Hospital Nordsjaelland
RECRUITING
Hillerød
Copenhagen University Hospital Hvidovre
RECRUITING
Hvidovre
Bornholms Hospital
RECRUITING
Rønne
Contact Information
Primary
Henrik Hansen, PhD
henrik.hansen.09@regionh.dk
+4528946780
Backup
Christina Nielsen, PT, Msc
christina.nielsen.07@regionh.dk
+4520952588
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 180
Treatments
Experimental: pulmonary tele-rehabilitation (PTR)
Recieve supervised PTR 2/weekly, session duration of 60 min; 35 min of exercise and 25min of patient education for 10-weeks (primary endpoint).~Delivered from Hvidovre/Bispebjerg Hospital to groups of 4-6 patients who exercise at home and communicate via tablet-camera.~After 10-weeks of PTR, participants are offered once weekly PTR for 60minuttes in groups of 4-8 patients throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).
Experimental: home-based pulmonary rehabilitation (HPR)
HPR is an individual self-initiated home-based PR program. Patient goal is to achieve at least 20 min of self-initiated muscle-endurance based exercise 3days/weekly for 10-weeks (primary endpoint).~The first session is a home visit by an experienced respiratory physiotherapist and with focus on establishment of exercise goals, formal exercise prescription and education.~The home visit is followed by 1/weekly session for 10-weeks.The sessions is delivered from Hvidovre/Bispebjerg Hospital via tablet-camera or telephone call.~After 10-weeks of HPR, participants are offered once weekly PTR for 60min in groups of 4-8 patients throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).
Active_comparator: Control
Control group will receive usual care; medication, scheduled follow-up visit and possible phone contact with GP or the outpatient respiratory department. Except for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered.
Sponsors
Leads: Copenhagen University Hospital, Hvidovre
Collaborators: University Hospital Bispebjerg and Frederiksberg, Herlev and Gentofte Hospital, Hillerod Hospital, Denmark

This content was sourced from clinicaltrials.gov