Chronic Obstructive Pulmonary DiseaseREPORTNCT05664945
Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial
A study testing pulmonary tele-rehabilitation (PTR) and home-based pulmonary rehabilitation (HPR) in people with Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Hvidovre at 7 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- pulmonary tele-rehabilitation (PTR) and home-based pulmonary rehabilitation (HPR)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 7 sitesDenmark
- Study dates
- 10 Jan 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Copenhagen University Hospital Amager
Copenhagen, Greater Copenhagen, 2300
Copenhagen University Hospital Bispebjerg-Frederiksberg
Copenhagen, Greater Copenhagen, 2400
Municipality of Copenhagen
Copenhagen, 2100
Copenhagen University Hospital Herlve-Gentofte
Gentofte Municipality, Greater Copenhagen, 2820
Copenhagen University Hospital Nordsjaelland
Hillerød, Greater Copenhagen, 3400
Copenhagen University Hospital Hvidovre
Hvidovre, Greater Copenhagen, 2650
Bornholms Hospital
Rønne, 3700
About this study
Official title: Rethinking Pulmonary Rehabilitation for Patients With COPD: a Three-arm Randomised Multicentre Trial (REPORT-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.
Read more
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.
Read the 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
- 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)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- pulmonary tele-rehabilitation (PTR), home-based pulmonary rehabilitation (HPR), Control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary tele-rehabilitation (PTR)Behavioural
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)Behavioural
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).
ControlBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| pulmonary tele-rehabilitation (PTR) | Experimental | 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). Receives: Behavioral: pulmonary tele-rehabilitation (PTR) |
| home-based pulmonary rehabilitation (HPR) | Experimental | 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). Receives: Behavioral: home-based pulmonary rehabilitation (HPR) |
| Control | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COPD Assessment Test (CAT)
Patient completed questionnaires that assess respiratory symptoms. Eight item questionaire with total score from 0-40 points.
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Secondary outcomes (14)
Change in 1-minute sit-to-stand test (1-min-STS)
measures endurance
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Change in 30seconds sit-to-stand test (30sec-STS)
measures muscle strength
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Change in Short Physcial Performance Battery (SPPB)
Measures frailty/possible sarcopenia/ mobility disaabilities
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Change in Handgrip strength (JAMAR)
measures handgrip muscle strength in kilo. High is better
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Changes in objectively measured physical acitivity (50% of total sample)
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
Measured: Baseline; 10-weeks from baseline ( primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Change in Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Change in Euro Qol (EQ5D-3L)
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
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Change Brief Pain Inventory (BPI)
Patient completed questionnaires that assess pain. Low score is better
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Change Multidimensional Fatigue Inventory (MFI-20)
Patient completed questionnaires that assess pain. Low score is better
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Change Pittsburg Sleep Quality Index (PSQI)
Interview completed questionnaire that assess sleep quality. Low score is better
Measured: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Program completion
The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
Measured: at 10-weeks from baseline (primary endpoint); 75-weeks from baseline (secondary endpoint)
Number of hospital admissions (respiratory related and all-cause)
Total number
Measured: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Mortality (respiratory related and all-cause)
Total number
Measured: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Adverse events
numbers of SAE and AE
Measured: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start10 Jan 2023
- Primary completion7 Oct 2025
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical, assessor- and statistician blinded multicentre trial with three parallel-groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Henrik Hansen, Copenhagen University Hospital, Hvidovre
- Investigators
- Henrik Hansen, PhD, Principal investigator, Dept. of Respiratory Medicine, University Hospital HvidovreNina Godtfredsen, MD, PhD, Study chair, Dept. of Respiratory Medicine, University Hospital Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664945
- Sponsor's protocol ID
- H-22015777
- Acronym
- REPORT
- Status last verified
- Mar 2026
- First submitted
- 9 Dec 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access demands a part application to; (1) Danish Data Protection agency, (2) ethics committee of the capital region, (3) national health Data authorities. Only if the applications are approved data will be considered available for sharing. The investigator will not be able to support this process.
Publications
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.
PubMed 39774509
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rethinking Pulmonary Rehabilitation for Patients With COPD: a Three-arm Randomised Multicentre Trial (REPORT-trial)
- ClinicalTrials.gov ID
- NCT05664945
- Acronym / sponsor ID
- REPORT / H-22015777
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Herlev and Gentofte Hospital
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized clinical, assessor- and statistician blinded multicentre trial with three parallel-groups
| Arm | Type | Receives |
|---|---|---|
| pulmonary tele-rehabilitation (PTR) | Experimental | Behavioral: 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). |
| home-based pulmonary rehabilitation (HPR) | Experimental | Behavioral: 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 | Active comparator | Behavioral: ControlControl 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | pulmonary tele-rehabilitation (PTR) |
| 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). | Behavioural | home-based pulmonary rehabilitation (HPR) |
| ControlReceive 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). | Behavioural | Control |
Primary outcome
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.
14 secondary outcomes
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)
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)
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)
Change in Handgrip strength (JAMAR)
Time frame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
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)
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)
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)
Change Brief Pain Inventory (BPI)
Time frame: Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
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)
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)
Program completion
Time frame: at 10-weeks from baseline (primary endpoint); 75-weeks from baseline (secondary endpoint)
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)
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)
Adverse events
Time frame: at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 39774509Nielsen 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.
- Individual participant dataSharing planned: No. Access demands a part application to; (1) Danish Data Protection agency, (2) ethics committee of the capital region, (3) national health Data authorities. Only if the applications are approved data will be considered available for sharing. The investigator will not be able to support this process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Hansen, PhD principal investigator
Dept. of Respiratory Medicine, University Hospital Hvidovre
Nina Godtfredsen, MD, PhD study chair
Dept. of Respiratory Medicine, University Hospital Hvidovre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary tele-rehabilitation (PTR) and home-based pulmonary rehabilitation (HPR) in people with Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Hvidovre at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05664945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.