Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial (REPORT)

Copenhagen University Hospital, Hvidovre

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: home-based pulmonary rehabilitation (HPR); Behavioral: pulmonary tele-rehabilitation (PTR); Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05664945

H-22015777

Details and patient eligibility

About

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.

Full description

This trial will investigate if pulmonary tele-rehabilitation (PTR) and home-based pulmonary rehabilitation (HPR) leads to respiratory symptom relief (CAT score) and improvements on secondary outcomes in patients unable to access conventional rehabilitation programs (standard PR offer).

Our hypotheses in a three-arm RCT design are

1. PTR and HPR will be equivalent to each other
2. PTR and HPR will be superior to usual care, that is the control group (CON - no intervention)

Enrollment: 180 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 3 patient groups

pulmonary tele-rehabilitation (PTR)

Experimental group

Description:

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).

Treatment:

Behavioral: pulmonary tele-rehabilitation (PTR)

home-based pulmonary rehabilitation (HPR)

Experimental group

Description:

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).

Treatment:

Behavioral: home-based pulmonary rehabilitation (HPR)

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control