Clinical trial NCT05664945: Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial
Official title: Rethinking Pulmonary Rehabilitation for Patients With COPD: a Three-arm Randomised Multicentre Trial (REPORT-trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: University Hospital Bispebjerg and Frederiksberg
name: Hillerod Hospital, Denmark
name: Herlev and Gentofte Hospital
First posted: 2022-12-27
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical, assessor- and statistician blinded multicentre trial with three parallel-groups
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Change in COPD Assessment Test (CAT)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Secondary outcomes:
measure: Change in 1-minute sit-to-stand test (1-min-STS)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Change in 30seconds sit-to-stand test (30sec-STS)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Change in Short Physcial Performance Battery (SPPB)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Change in Handgrip strength (JAMAR)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Changes in objectively measured physical acitivity (50% of total sample)
timeFrame: Baseline; 10-weeks from baseline ( primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Change in Euro Qol (EQ5D-3L)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Change Brief Pain Inventory (BPI)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Change Multidimensional Fatigue Inventory (MFI-20)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Change Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Program completion
timeFrame: at 10-weeks from baseline (primary endpoint); 75-weeks from baseline (secondary endpoint)
measure: Number of hospital admissions (respiratory related and all-cause)
timeFrame: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Mortality (respiratory related and all-cause)
timeFrame: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Adverse events
timeFrame: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Amager
state: Greater Copenhagen
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Bispebjerg-Frederiksberg
state: Greater Copenhagen
city: Gentofte
country: Denmark
facility: Copenhagen University Hospital Herlve-Gentofte
state: Greater Copenhagen
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital Nordsjaelland
state: Greater Copenhagen
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
state: Greater Copenhagen
city: Copenhagen
country: Denmark
facility: Municipality of Copenhagen
city: Rønne
country: Denmark
facility: Bornholms Hospital
Study officials:
affiliation: Dept. of Respiratory Medicine, University Hospital Hvidovre
name: Henrik Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Respiratory Medicine, University Hospital Hvidovre
name: Nina Godtfredsen, MD, PhD
role: STUDY_CHAIR
References:
citation: Nielsen C, Godtfredsen N, Molsted S, Ulrik C, Kallemose T, Hansen H. Supervised pulmonary tele-rehabilitation and individualized home-based pulmonary rehabilitation for patients with COPD, unable to participate in center-based programs. The protocol for a multicenter randomized controlled trial - the REPORT study. PLoS One. 2025 Jan 7;20(1):e0312742. doi: 10.1371/journal.pone.0312742. eCollection 2025.