Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Characteristics of People With Advanced Chronic Obstructive Pulmonary Disease (COPD) - A Multicenter Study

NCT04249388

COPD

COMPLETED

COPD Rehabilitation in Primary and Secondary Health Care

NCT00320333

Chronic Obstructive Pulmonary Disease

UNKNOWN

Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD

NCT06636487

Idiopathic Pulmonary Fibrosis (IPF) Sarcoidosis Bronchiectasis +2 more

RECRUITING NA

Optimizing the Effect of COPD Rehabilitation

NCT00419289

Chronic Obstructive Pulmonary Disease

UNKNOWN NA

COPD-EXA-REHAB. Early Pulmonary Rehabilitation of Patients With Acute Exacerbation of COPD

NCT02987439

Chronic Obstructive Lung Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized clinical, assessor- and statistician blinded multicentre trial with three parallel-groups

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Participants will be informed that the trial is assessing the impact of pulmonary rehabilitation models on predetermined outcomes, but not the specific nature of the models of interest, and the predetermined hypothesis of the intervention group allocated to.

All assessors are blinded to group allocation and previous test results. In case of failure keeping the outcome assessor blinded (that is, if a participant reveals his/her allocation) a second assessor will be available to step in and conduct the assessment on another day.

To avoid investigators (subconscious) bias the biostatistician who perform the data analyses and validate the results is blinded to group allocation.

The research group will interpret the results, before the allocation code is broken.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

pulmonary tele-rehabilitation (PTR)

Intervention Type BEHAVIORAL

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).

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).

Group Type EXPERIMENTAL

home-based pulmonary rehabilitation (HPR)

Intervention Type BEHAVIORAL

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).

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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).

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No