COPD (Chronic Obstructive Pulmonary Disease)e-PURENCT06915740
Virtual Pulmonary Rehabilitation Program for COPD Patients; a Pilot Study
A study testing Exercise in people with COPD (Chronic Obstructive Pulmonary Disease), run by Turku University Hospital at 2 sites in Finland.
Trial summary
The goal of this pilot study is to investigate the feasibility of a virtual rehabilitation program in COPD patients. The main questions it aims to answer are: 1. To facilitate a safe rollout of the remote rehabilitation program for COPD patients in Southwest Finland. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFinland
- Study dates
- 31 Mar 2025to 30 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the remote rehabilitation program for COPD patients, fulfilling criteria 1a, 1b and 1c 1a Documented COPD diagnosis (ICD 10 code J44) 1b Expected survival > 1 year 1c Sufficient technical and language skills for safe participation in the program
- Signed informed consent
Who cannot join
- Severe comorbidities with expected survival of less than 1 year
- Clinical suspicion that remote rehabilitation may be unsafe.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Turku University Hospital
Turku, Southwest Finland, 20540
Matthijs Feuth, MD PhD, +358505222163, matfeu@utu.fi
Maritta Kilpeläinen, MD PhD, +358505663340, maritta.kilpalainen@varha.fi
- Not yet recruiting
Turku University Hospital
Turku, 20540
Matthijs Feuth, MD PhD, +358505222163, matfeut@utu.fi
Maritta Kilpeläinen, MD PhD, +35823134739, maritta.kilpelainen@varha.fi
About this study
The goal of this pilot study is to investigate the feasibility of a virtual rehabilitation program in COPD patients. The main questions it aims to answer are:
- To facilitate a safe rollout of the remote rehabilitation program for COPD patients in Southwest Finland.
- To identify and subsequently improve limitations of the rehabilitation program.
- To evaluate the levels of participant engagement and adherence to the digital COPD rehabilitation program over an extended period to understand its sustainability and long-term impact.
- To determine the effectiveness of the digital COPD rehabilitation program in improving lung function, exercise capacity, and quality of life among participants
- To assess the impact of the digital program on healthcare resource utilization, including hospital readmissions, emergency room visits, and outpatient visits related to COPD management.
- To measure participant satisfaction, usability, and overall experience with the digital platform to identify areas for improvement and enhance user engagement.
- To evaluate the cost-effectiveness of implementing the digital program compared to conventional rehabilitation methods, considering direct healthcare costs.
Participants will be enrolled in a virtual rehabilitation program, and a proportion of the patients is invited for focus group discussion to assess their experiences.
Read the detailed description
The e-PURE study is an investigator initiated study, which aims to evaluate the feasibility, effectiveness, and long-term outcomes of a digital pulmonary rehabilitation program designed for patients with Chronic Obstructive Pulmonary Disease (COPD) in Southwest Finland. This pilot study assesses patient adherence, lung function, exercise capacity, quality of life, and the program's potential impact on healthcare utilization.
COPD is a common disease, affecting mostly elderly, with significant impact on life expectancy and quality of life. Pulmonary rehabilitation (PR) is an essential intervention for COPD patients, known to enhance health-related quality of life and reduce symptoms like shortness of breath. Traditional PR programs are underutilized due to accessibility barriers, with less than 1% of COPD patients in Canada and 3.7% in the U.S. attending such programs. The COVID-19 pandemic exacerbated these challenges by halting in-person PR programs. Virtual PR offers a promising, non-inferior alternative. The e-PURE study responds to this need by rolling out a digital rehabilitation program developed by a multidisciplinary team of healthcare professionals.
This is a single-arm observational pilot study enrolling up to 50 COPD patients. The rehabilitation program spans around 12 weeks, with follow-up assessments at 16 and 26 weeks post-enrolment. Patients undergo a tailored rehabilitation plan that includes individualized exercise routines, nutritional counselling, and smoking cessation support. Progress is reported through questionnaires and clinical evaluations such as the 6-minute walk test.
The primary outcome measure is the improvement in distance during the 6-minute walk test after the program, compared to baseline. Secondary outcomes include patient satisfaction, changes in the St. George Respiratory Questionnaire, and healthcare resource utilization (hospital readmissions, emergency visits).
The pilot study will identify whether a larger follow-up study is feasible, and indicate the number of patients to recruit.
- Being tested
- Exercise
- Keywords
- copd, pulmonary rehabilitation, telemedicine, exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
virtual rehabilitation, including endurance exercise, strength training, breathing exercises, patient education, dietary advice
| Study group | Role | What they receive |
|---|---|---|
| virtual pulmonary rehabilitation | Other | Participation in a virtual pulmonary rehabilitation program developed by a multidisciplinary team Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test
6 minutes walking test after the rehabilitation program in comparison to baseline
Measured: from enrollment to 16-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start31 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Matthijs Feuth, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915740
- Sponsor's protocol ID
- T1649/2024
- Acronym
- e-PURE
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy policy does not allow to share individual participant data
Publications
Holland AE, Cox NS, Houchen-Wolloff L, Rochester CL, Garvey C, ZuWallack R, Nici L, Limberg T, Lareau SC, Yawn BP, Galwicki M, Troosters T, Steiner M, Casaburi R, Clini E, Goldstein RS, Singh SJ. Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2021 May;18(5):e12-e29. doi: 10.1513/AnnalsATS.202102-146ST.
PubMed 33929307Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633Janjua S, Banchoff E, Threapleton CJ, Prigmore S, Fletcher J, Disler RT. Digital interventions for the management of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD013246. doi: 10.1002/14651858.CD013246.pub2.
PubMed 33871065
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Pulmonary Rehabilitation Program for COPD Patients; a Pilot Study
- ClinicalTrials.gov ID
- NCT06915740
- Acronym / sponsor ID
- e-PURE / T1649/2024
- Keywords
- copd, pulmonary rehabilitation, telemedicine, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Apr 2025 (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 goal of this pilot study is to investigate the feasibility of a virtual rehabilitation program in COPD patients. The main questions it aims to answer are:
- To facilitate a safe rollout of the remote rehabilitation program for COPD patients in Southwest Finland.
- To identify and subsequently improve limitations of the rehabilitation program.
- To evaluate the levels of participant engagement and adherence to the digital COPD rehabilitation program over an extended period to understand its sustainability and long-term impact.
- To determine the effectiveness of the digital COPD rehabilitation program in improving lung function, exercise capacity, and quality of life among participants
- To assess the impact of the digital program on healthcare resource utilization, including hospital readmissions, emergency room visits, and outpatient visits related to COPD management.
- To measure participant satisfaction, usability, and overall experience with the digital platform to identify areas for improvement and enhance user engagement.
- To evaluate the cost-effectiveness of implementing the digital program compared to conventional rehabilitation methods, considering direct healthcare costs.
Participants will be enrolled in a virtual rehabilitation program, and a proportion of the patients is invited for focus group discussion to assess their experiences.
Detailed description
The e-PURE study is an investigator initiated study, which aims to evaluate the feasibility, effectiveness, and long-term outcomes of a digital pulmonary rehabilitation program designed for patients with Chronic Obstructive Pulmonary Disease (COPD) in Southwest Finland. This pilot study assesses patient adherence, lung function, exercise capacity, quality of life, and the program's potential impact on healthcare utilization.
COPD is a common disease, affecting mostly elderly, with significant impact on life expectancy and quality of life. Pulmonary rehabilitation (PR) is an essential intervention for COPD patients, known to enhance health-related quality of life and reduce symptoms like shortness of breath. Traditional PR programs are underutilized due to accessibility barriers, with less than 1% of COPD patients in Canada and 3.7% in the U.S. attending such programs. The COVID-19 pandemic exacerbated these challenges by halting in-person PR programs. Virtual PR offers a promising, non-inferior alternative. The e-PURE study responds to this need by rolling out a digital rehabilitation program developed by a multidisciplinary team of healthcare professionals.
This is a single-arm observational pilot study enrolling up to 50 COPD patients. The rehabilitation program spans around 12 weeks, with follow-up assessments at 16 and 26 weeks post-enrolment. Patients undergo a tailored rehabilitation plan that includes individualized exercise routines, nutritional counselling, and smoking cessation support. Progress is reported through questionnaires and clinical evaluations such as the 6-minute walk test.
The primary outcome measure is the improvement in distance during the 6-minute walk test after the program, compared to baseline. Secondary outcomes include patient satisfaction, changes in the St. George Respiratory Questionnaire, and healthcare resource utilization (hospital readmissions, emergency visits).
The pilot study will identify whether a larger follow-up study is feasible, and indicate the number of patients to recruit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| virtual pulmonary rehabilitation | Other | Other: ExerciseParticipation in a virtual pulmonary rehabilitation program developed by a multidisciplinary team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participation in the remote rehabilitation program for COPD patients, fulfilling criteria 1a, 1b and 1c 1a Documented COPD diagnosis (ICD 10 code J44) 1b Expected survival > 1 year 1c Sufficient technical and language skills for safe participation in the program
- Signed informed consent
Key exclusion criteria (2 listed)
- Severe comorbidities with expected survival of less than 1 year
- Clinical suspicion that remote rehabilitation may be unsafe.
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 |
|---|---|---|
| Exercisevirtual rehabilitation, including endurance exercise, strength training, breathing exercises, patient education, dietary advice | Other | virtual pulmonary rehabilitation |
Primary outcome
6 minutes walking test
Time frame: from enrollment to 16-26 weeks
6 minutes walking test after the rehabilitation program in comparison to baseline
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 8 Apr 2025.
- Background: PubMed 33929307Holland AE, Cox NS, Houchen-Wolloff L, Rochester CL, Garvey C, ZuWallack R, Nici L, Limberg T, Lareau SC, Yawn BP, Galwicki M, Troosters T, Steiner M, Casaburi R, Clini E, Goldstein RS, Singh SJ. Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2021 May;18(5):e12-e29. doi: 10.1513/AnnalsATS.202102-146ST.
- Background: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- Background: PubMed 33871065Janjua S, Banchoff E, Threapleton CJ, Prigmore S, Fletcher J, Disler RT. Digital interventions for the management of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD013246. doi: 10.1002/14651858.CD013246.pub2.
- Individual participant dataSharing planned: No. Privacy policy does not allow to share individual participant data
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with COPD (Chronic Obstructive Pulmonary Disease), run by Turku University Hospital at 2 sites in Finland.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking test (time frame: from enrollment to 16-26 weeks). 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 NCT06915740, which also lists 3 linked publications.
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 8 Apr 2025.