Idiopathic Pulmonary Fibrosis (IPF)ExPuReNCT06636487
Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD
A study testing pulmonary tele-rehabilitation (PTR) and Home-based pulmonary rehabilitation (HPR) in people with Idiopathic Pulmonary Fibrosis (IPF) and Sarcoidosis, run by Copenhagen University Hospital, Hvidovre at 5 sites in Denmark.
Trial summary
The purpose of this pilot randomized clinical trial is to evaluate the willingness, acceptance, adherence and signs of benefits of structured home-based pulmonary rehabilitation (HPR) and supervised pulmonary tele-rehabilitation (PTR) on respiratory symptoms, quality of life, functioning and physical activity in… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF), Sarcoidosis, Bronchiectasis
- 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
- 50 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Nov 2024to 31 May 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
- Residency in the Capital Region of Copenhagen
- A clinically assessed need for pulmonary rehabilitation including respiratory symptoms, corresponding to MRC grade 2 or higher and where:
- Center-based PR is not standard available or
- Center-based PR being declined by the patient
- Able to stand up from a chair (height 44-46cm) and walk 10 meters independently (with or without a walking aid)
- Capable of lifting both arms to horizontal with at least 1 kg dumbbells in each hand
Show all 13Show fewer
- And a minimum of one of the below mentioned diagnoses:
- ILD (Interstitial lung disease, Idiopathic pulmonary fibrosis, Sarcoidosis):
- DLCO lower than 80 % or FVC lower than 80%, HRCT verified, Age higher than 40 years, Confirmed respiratory physician diagnosis
- Asthma:
- With chronic airway obstruction, ACQ score higher than 1, FEV1 lower than 80%, Age higher than 50 years, Confirmed respiratory physician diagnosis of Asthma
- Bronchiectasis:
- FEV1 lower than 80%, HRCT verified, Age higher than 40 years, Confirmed respiratory physician diagnosis
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Copenhagen University Center, Amager
Copenhagen, Greater Copenhagen, 2300
Copenhagen University Center, Frederiksberg-Bispebjerg
Copenhagen, Greater Copenhagen, 2400
Copenhagen University Center, Hvidovre
Copenhagen, Greater Copenhagen, 2650
Copenhagen University Center, Herlev-Gentofte
Gentofte Municipality, Greater Copenhagen, 2820
Copenhagen University Center, Hillerød
Hillerød, Greater Copenhagen, 3400
About this study
Official title: Expanding Pulmonary Rehabilitation in Other Chronic Respiratory Disease Than COPD - the ExPuRe Pilot Study
The purpose of this pilot randomized clinical trial is to evaluate the willingness, acceptance, adherence and signs of benefits of structured home-based pulmonary rehabilitation (HPR) and supervised pulmonary tele-rehabilitation (PTR) on respiratory symptoms, quality of life, functioning and physical activity in patients with ILD (Interstitial lung disease, Idiopathic pulmonary fibrosis, Sarcoidosis), Bronchiectasis and Asthma who have a clinically assessed need for a pulmonary rehabilitation program.
The main questions the project aims to answer are:
Read more
- Will HPR and PTR appeal to a minimum of 30% of the eligble patients
- Be greatly accepted (≥70% of participant complete 70% or more of the planned sessions) by patients agreeing to participate in the study
- Will PTR and HPR lead to positive changes in respiratory symptom relief, symptom relief in general and improve or maintain physical functioning larger than usual care
Researchers will compare with a comparable control group who gets usual care (scheduled controls and medication but no exercise intervention) to examine the willingness to be randomized and to get an indication on possible health related effects. Participants will be randomly assigned to one of three groups:
- A structured supervised group-based PTR (exercise twice a week; each session consists of 35 min. evidence-based exercises and 25 min. of patient education)
- An individual HPR program (self-initiated physical activity) with motivational and professional counseling once a week (10-15min), supported by a tablet screen
- A control group receiving usual care (CON)
Read the detailed description
Primary objective of the ExPuRe study is to evaluate the willingness, acceptance, adherence and signs of benefits of structured home-based pulmonary rehabilitation (HPR) and supervised pulmonary tele-rehabilitation (PTR) on respiratory symptoms, quality of life, functioning and physical activity in patients with ILD, Asthma and BE, who have a clinically assessed need for a pulmonary rehabilitation program.
The hypotheses are that HPR and PTR will appeal to 30% of the eligble patients, be greatly accepted (≥70% of participant complete 70% or more of the planned sessions) by patients agreeing to participate in the study, and that PTR and HPR will lead to positive changes in respiratory symptom relief, symptom relief in general and improve or maintain physical functioning larger than usual care, that is the control group (CON - no intervention).
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Sarcoidosis, Bronchiectasis, Asthma Bronchiale, Interstitial Lung Diseases (ILD)
- Being tested
- pulmonary tele-rehabilitation (PTR), Home-based pulmonary rehabilitation (HPR), Control
- Keywords
- Pilot RCT Study, Telerehabilitation, home-based pulmonary rehabilitation, pulmonary tele-rehabilitation
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Sarcoidosis, Bronchiectasis, Lung Diseases, Interstitial
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 3 - 5 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.
Specific exercises are evidence-based; been used in several intervention studies on patients with CRD (eg. 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 CRD. Every sixth education session consists of 25 min Mindfulness exercises developed for CRD 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
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. Exercises are evidence based; used in several intervention studies on patients with CRD (eg. 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 access to mindfulness exercises and an educationbook. The home visit is followed by one weekly session for 10-weeks. A menu of topics relevant to CRD 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
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 their decision 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 25 min of patient education for 10-weeks. Delivered from Hvidovre/Bispebjerg Hospital to groups of 3 - 5 patients who exercise at home and communicate via tablet-camera. After 10-weeks of PTR, participants are offered once weekly PTR for 60 minutes in groups of 4-8 patients throughout a 65-week maintenance period 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 3 days/ weekly for 10-weeks 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 60 min in groups of 4-8 patients throughout a 65-week maintenance period. 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.
Eligibility
Number of eligible patients for randomisation (Absolute number)
Measured: Assesment before enrollment
Adherence
Number of participants adherent (Participant completion of 70% or more of the planned sessions) (Absolute number)
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Acceptability
Number of patients accepting to participate (Absolute number)
Measured: Acceptance when enrolling the project
Secondary outcomes (16)
COPD Assessment Test (CAT) / Chronic Airways Assessment Test (CAAT)
A patient self administered questionaire. An 8-item questionnaire designed to assess the impact of disease on a person's life (health status). Range of CAT scores from 0-40. Higher scores implicates a more severe impact of COPD on a patient's life(total score point) .
respiratory symptoms BE (CAT) respiratory symptoms Asthma (CAAT)
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Asthma Control Questionnaire (ACQ-7)
A 7-item asthma specific questionaire to measure the adequacy of asthma control and change in asthma control. Scores range between 0 (totally controlled) and 6 (severely uncontrolled). The ACQ score is calculated as the average of 5, 6 or 7 items (total score point) . Only for those with Asthma
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Kings Brief Interstitial Lung Disease
The KBILD is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale. It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status. (total score point) - only for those with ILD
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
EuroQol-5D-3L (EQ-5D-3L)
Patient completed questionaires that assess quality of life. Total score from 0-1 on EQ5D- health domain. Total score from 0 - 100 mm on EQ5D-VAS domain. No total domain score.
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Multidimensional Fatigue Inventory (MFI-20)
A patient completed questionaire with a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Items are scored 1-5. In the final score, high scores represent more fatigue (total score point)
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Pittsburg Sleep Quality Index (PSQI)
A self-rated 19-item questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality (total score point).
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
ActivePAL triaxial accelerometer (PAL) / SENS motion (PAL) (≥50% of total sample
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; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
1-minute sit to stand (1-min-STS)
A clinical test where the patient performes as many sit to stand actions as possible in one minute. Measures endurance by counting the number of repetitions.
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
30-second sit to stand (30-sec-STS)
A clinical test where the patient performes as many sit to stand actions as possible in 30 seconds. Measures leg muscle strength by counting the number of repetitions.
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Hand-grip strength (Jamar dynamometer)
Measure hangrip muscle strengt in kilo. The higher the better
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Number of hospital admissions (respiratory related and all-cause)
Report of the total number
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Mortality (respiratory related and all-cause)
Report of the total number
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Adverse events
Report of the numbers of severe adverse events and adverse events
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Brief Pain Inventory (BPI)
A nine item self-administered questionnaire used to evaluate the severity of a patients pain and the impact of this pain on the patients daily functioning. The Every symptom are rated on severity scale ranging from 0 - 10 (total score point).
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Short Physical Performance Battery and (SPPB)
An objective measurement instrument combining three test in one score. The tests consist of a balance test (measured in seconds), lower extremity strength (measured in seconds), and a walkning test measuring functional capacity (measured in seconds) in older adults (65 years of age). Score measured in seconds
Measured: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Hospital Anxiety and Depression Scale (HADS)
Patient self administered questionaires that assess anxiety and depression symptoms. Seven item domain questions for depression with a total score form of 0 - 21 points. Seven item domain questions for anxiety with total score from 0 - 21 points (total score point) .
Measured: Baseline; 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 posted10 Oct 2024
- Study start1 Nov 2024
- Primary completion30 Sep 2025
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies 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
- Health services research
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Copenhagen University Hospital at Herlev, Nordsjaellands Hospital
- Responsible party
- Principal investigator, Henrik Hansen, Copenhagen University Hospital, Hvidovre
- Investigators
- Henrik Hansen, PhD, Msc, PT, 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
- NCT06636487
- Sponsor's protocol ID
- Add-on 96052 to H-22015777
- Acronym
- ExPuRe
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2024
- Last updated
- 9 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Pulmonary Rehabilitation in Other Chronic Respiratory Disease Than COPD - the ExPuRe Pilot Study
- ClinicalTrials.gov ID
- NCT06636487
- Acronym / sponsor ID
- ExPuRe / Add-on 96052 to H-22015777
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Sarcoidosis, Bronchiectasis, Asthma Bronchiale, Interstitial Lung Diseases (ILD)
- Keywords
- Pilot RCT Study, Telerehabilitation, home-based pulmonary rehabilitation, pulmonary tele-rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Copenhagen University Hospital at Herlev, Nordsjaellands Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Oct 2024 (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.
The purpose of this pilot randomized clinical trial is to evaluate the willingness, acceptance, adherence and signs of benefits of structured home-based pulmonary rehabilitation (HPR) and supervised pulmonary tele-rehabilitation (PTR) on respiratory symptoms, quality of life, functioning and physical activity in patients with ILD (Interstitial lung disease, Idiopathic pulmonary fibrosis, Sarcoidosis), Bronchiectasis and Asthma who have a clinically assessed need for a pulmonary rehabilitation program.
The main questions the project aims to answer are:
- Will HPR and PTR appeal to a minimum of 30% of the eligble patients
- Be greatly accepted (≥70% of participant complete 70% or more of the planned sessions) by patients agreeing to participate in the study
- Will PTR and HPR lead to positive changes in respiratory symptom relief, symptom relief in general and improve or maintain physical functioning larger than usual care
Researchers will compare with a comparable control group who gets usual care (scheduled controls and medication but no exercise intervention) to examine the willingness to be randomized and to get an indication on possible health related effects. Participants will be randomly assigned to one of three groups:
- A structured supervised group-based PTR (exercise twice a week; each session consists of 35 min. evidence-based exercises and 25 min. of patient education)
- An individual HPR program (self-initiated physical activity) with motivational and professional counseling once a week (10-15min), supported by a tablet screen
- A control group receiving usual care (CON)
Detailed description
Primary objective of the ExPuRe study is to evaluate the willingness, acceptance, adherence and signs of benefits of structured home-based pulmonary rehabilitation (HPR) and supervised pulmonary tele-rehabilitation (PTR) on respiratory symptoms, quality of life, functioning and physical activity in patients with ILD, Asthma and BE, who have a clinically assessed need for a pulmonary rehabilitation program.
The hypotheses are that HPR and PTR will appeal to 30% of the eligble patients, be greatly accepted (≥70% of participant complete 70% or more of the planned sessions) by patients agreeing to participate in the study, and that PTR and HPR will lead to positive changes in respiratory symptom relief, symptom relief in general and improve or maintain physical functioning larger than usual care, that is the control group (CON - no intervention).
Study design
- Primary purpose
- Health services research
- 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 25 min of patient education for 10-weeks. Delivered from Hvidovre/Bispebjerg Hospital to groups of 3 - 5 patients who exercise at home and communicate via tablet-camera. After 10-weeks of PTR, participants are offered once weekly PTR for 60 minutes in groups of 4-8 patients throughout a 65-week maintenance period |
| 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 3 days/ weekly for 10-weeks 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 60 min in groups of 4-8 patients throughout a 65-week maintenance period. |
| 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 (13 listed)
- Residency in the Capital Region of Copenhagen
- A clinically assessed need for pulmonary rehabilitation including respiratory symptoms, corresponding to MRC grade 2 or higher and where:
- Able to stand up from a chair (height 44-46cm) and walk 10 meters independently (with or without a walking aid)
- Capable of lifting both arms to horizontal with at least 1 kg dumbbells in each hand
- And a minimum of one of the below mentioned diagnoses:
Key exclusion criteria (4 listed)
- 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
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 3 - 5 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. Specific exercises are evidence-based; been used in several intervention studies on patients with CRD (eg. 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 CRD. Every sixth education session consists of 25 min Mindfulness exercises developed for CRD 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 | 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. Exercises are evidence based; used in several intervention studies on patients with CRD (eg. 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 access to mindfulness exercises and an educationbook. The home visit is followed by one weekly session for 10-weeks. A menu of topics relevant to CRD 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 | 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 their decision 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
Eligibility
Time frame: Assesment before enrollment
Number of eligible patients for randomisation (Absolute number)
Adherence
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Number of participants adherent (Participant completion of 70% or more of the planned sessions) (Absolute number)
Acceptability
Time frame: Acceptance when enrolling the project
Number of patients accepting to participate (Absolute number)
16 secondary outcomes
COPD Assessment Test (CAT) / Chronic Airways Assessment Test (CAAT)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Asthma Control Questionnaire (ACQ-7)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Kings Brief Interstitial Lung Disease
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
EuroQol-5D-3L (EQ-5D-3L)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Pittsburg Sleep Quality Index (PSQI)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
ActivePAL triaxial accelerometer (PAL) / SENS motion (PAL) (≥50% of total sample
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
1-minute sit to stand (1-min-STS)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
30-second sit to stand (30-sec-STS)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Hand-grip strength (Jamar dynamometer)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Number of hospital admissions (respiratory related and all-cause)
Time frame: Baseline; 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: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Adverse events
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Brief Pain Inventory (BPI)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Short Physical Performance Battery and (SPPB)
Time frame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline; 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 9 Mar 2026.
- 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, Msc, PT principal investigator
Dept. of Respiratory Medicine, University Hospital Hvidovre
Nina Godtfredsen, MD, PhD study chair
Dept. of Respiratory Medicine, University Hospital Hvidovre
5 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 Idiopathic Pulmonary Fibrosis (IPF) and Sarcoidosis, run by Copenhagen University Hospital, Hvidovre at 5 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 13 inclusion and 4 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 9 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 5 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?
Eligibility (time frame: Assesment before enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.