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Active, Not Recruiting

NCT Number: NCT05664945

Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital Amager, Copenhagen, Greater Copenhagen, Denmark

Loading trial locations.

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

pulmonary tele-rehabilitation (PTR)

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)

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

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).

Primary outcomes

  1. Change in COPD Assessment Test (CAT)

    Time frame: 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 outcomes

  1. Change in 1-minute sit-to-stand test (1-min-STS)

    Time frame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

    measures endurance

  2. Change in 30seconds sit-to-stand test (30sec-STS)

    Time frame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

    measures muscle strength

  3. Change in Short Physcial Performance Battery (SPPB)

    Time frame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

    Measures frailty/possible sarcopenia/ mobility disaabilities

  4. Change in Handgrip strength (JAMAR)

    Time frame: 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

  5. Changes in objectively measured physical acitivity (50% of total sample)

    Time frame: 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

  6. Change in Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  7. Change in Euro Qol (EQ5D-3L)

    Time frame: 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

  8. Change Brief Pain Inventory (BPI)

    Time frame: 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

  9. Change Multidimensional Fatigue Inventory (MFI-20)

    Time frame: 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

  10. Change Pittsburg Sleep Quality Index (PSQI)

    Time frame: 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

  11. Program completion

    Time frame: 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).

  12. Number of hospital admissions (respiratory related and all-cause)

    Time frame: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

    Total number

  13. Mortality (respiratory related and all-cause)

    Time frame: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

    Total number

  14. Adverse events

    Time frame: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

    numbers of SAE and AE

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Collaborators

  • Herlev and Gentofte Hospital
  • Hillerod Hospital, Denmark
  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study title

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

Acronym: REPORT

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Dec 27, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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