Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Behavioral: home-based pulmonary rehabilitation (HPR)Behavioral: ControlBehavioral: pulmonary tele-rehabilitation (PTR)
- Registration Number
- NCT05664945
- Lead Sponsor
- Copenhagen University Hospital, Hvidovre
- Brief 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.
- Detailed 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description home-based pulmonary rehabilitation (HPR) 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). Control 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. pulmonary tele-rehabilitation (PTR) 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).
- Primary Outcome Measures
Name Time Method Change in COPD Assessment Test (CAT) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Patient completed questionnaires that assess respiratory symptoms. Eight item questionaire with total score from 0-40 points.
- Secondary Outcome Measures
Name Time Method Change in Handgrip strength (JAMAR) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) measures handgrip muscle strength in kilo. High is better
Change Brief Pain Inventory (BPI) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Patient completed questionnaires that assess pain. Low score is better
Program completion at 10-weeks from baseline (primary endpoint); 75-weeks from baseline (secondary endpoint) The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
Change in 30seconds sit-to-stand test (30sec-STS) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) measures muscle strength
Change in Hospital Anxiety and Depression Scale (HADS) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Patient completed questionnaires that assess anxiety and depression symptoms. Seven item domain questions for depression with total score form 0-21 point. Seven item domain questions for anxiety with total score fra 0-21 points.
Change Multidimensional Fatigue Inventory (MFI-20) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Patient completed questionnaires that assess pain. Low score is better
Number of hospital admissions (respiratory related and all-cause) at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Total number
Mortality (respiratory related and all-cause) at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Total number
Change in 1-minute sit-to-stand test (1-min-STS) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) measures endurance
Change in Short Physcial Performance Battery (SPPB) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Measures frailty/possible sarcopenia/ mobility disaabilities
Changes in objectively measured physical acitivity (50% of total sample) Baseline; 10-weeks from baseline ( primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Devise is ActivePAL triaxial accelerometer (PAL Technologies Ltd., Glascow, UK). Wearing time is 24 h per day for 5 days at each time point. Measures sedentary and active body movements, steps per day and METs. High number of activity is better
Change in Euro Qol (EQ5D-3L) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Patient completed questionnaires that assess quality of life. Total score fra 0-1 on EQ5D-health domain. Total score from 0-100mm on EQ5D-vas domain. No total domain score
Change Pittsburg Sleep Quality Index (PSQI) Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) Interview completed questionnaire that assess sleep quality. Low score is better
Adverse events at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint) numbers of SAE and AE
Trial Locations
- Locations (7)
Copenhagen University Hospital Hvidovre
🇩🇰Hvidovre, Greater Copenhagen, Denmark
Municipality of Copenhagen
🇩🇰Copenhagen, Denmark
Copenhagen University Hospital Amager
🇩🇰Copenhagen, Greater Copenhagen, Denmark
Copenhagen University Hospital Bispebjerg-Frederiksberg
🇩🇰Copenhagen, Greater Copenhagen, Denmark
Copenhagen University Hospital Herlve-Gentofte
🇩🇰Gentofte, Greater Copenhagen, Denmark
Copenhagen University Hospital Nordsjaelland
🇩🇰Hillerød, Greater Copenhagen, Denmark
Bornholms Hospital
🇩🇰Rønne, Denmark