COPD, Chronic Obstructive Pulmonary DiseaseNCT04820257
Home-based Pulmonary Rehabilitation for COPD Patients
A study testing Home based exercise in people with COPD, Chronic Obstructive Pulmonary Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Home based exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2026to Dec 2028
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 40 years and older
- FEV1 <80% or less (forced expiratory volume in one second) as documented by pulmonary function.
- Medical diagnosis of COPD, GOLD classification B,D, and C based on symptoms and history of exacerbations.
- The patients must be able to access a smart-phone or computer tablet with internet service.
Who cannot join
- Unable to perform low intensity exercise.
- Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move, are not living in the healthcare area.
- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Karolinska Institutet
Stockholm
Marian Papp, PhD, +46706946553, marian.papp@ki.se
About this study
Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. This program will allow patients to complete Pulmonary Rehabilitation (PR) at home and promote behavior change and lead to a more active lifestyle for patients with COPD who have been prescribed PR.
The program will be able to effectively monitor daily step count. A health coach will receive more this detailed data and will guide weekly health coaching sessions designed to increase awareness of the physical activities completed and ignite inner motivation for healthy behaviors.
The proposed PR program is innovative and responds to an unmet need in chronic care for COPD patients in the context of COVID-19 pandemic and it mitigates the common accessibility barriers.
Read the detailed description
Specific aims will guide the proposed project:
- Aim 1: To determine the feasibility of the proposed home-based PR program. We will additionally address adherence and appropriateness of the program.
- Aim 2: To determine improvements in quality of life and mental health of the proposed home-based PR determined.
- Aim 3: To evaluate if the average number of daily step counts increase after the home-based PR program
- Being tested
- Home based exercise
- Keywords
- tele-health, behavioural change, motivational interviewing, home-based exercise, self-related health, quality of life
- 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.
Home based exerciseBehavioural
Exercise at home and behavioural change to increase daily exercise
| Study group | Role | What they receive |
|---|---|---|
| Home based exercise | Experimental | Home based exercise with health coaching Receives: Behavioral: Home based exercise |
| Usual care | No intervention | Usual care, waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease specific quality of life
Chronic Respiratory Questionnaire (CRQ)
Measured: 8-12 weeks
Modified Medical Research Council Dyspnea scale (mMRC),
Dyspnea
Measured: 8-12 weeks
COPD assessment Test (CAT)
assess symptoms of breathing
Measured: 8-12 weeks
Secondary outcomes (3)
GAD to asses anxiety and depression symptoms
assessing anxiety and depression symptoms
Measured: 8-12 weeks
Online breathing and mindful movement exercises/ exercise routine
Total time performing the breathing exercises
Measured: 8-12 weeks
Activity monitoring
number of steps
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Nov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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 COPD, Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- starting with a small pilot and will follow with parallell design RCT - starting later
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Papp, Karolinska Institutet
- Investigators
- Marian Papp, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820257
- Sponsor's protocol ID
- 2021-01151:DNR
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benzo MV, Hagstromer M, Nygren-Bonnier M, Benzo RP, Papp ME. Home-Based Physical Activity Program With Health Coaching for participants With Chronic Obstructive Pulmonary Disease in Sweden: A Proof-of-Concept Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2023 Sep 30;7(5):470-475. doi: 10.1016/j.mayocpiqo.2023.07.005. eCollection 2023 Oct.
PubMed 37811474
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Pulmonary Rehabilitation for COPD Patients
- ClinicalTrials.gov ID
- NCT04820257
- Acronym / sponsor ID
- 2021-01151:DNR
- Keywords
- tele-health, behavioural change, motivational interviewing, home-based exercise, self-related health, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Mar 2021 (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.
Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. This program will allow patients to complete Pulmonary Rehabilitation (PR) at home and promote behavior change and lead to a more active lifestyle for patients with COPD who have been prescribed PR.
The program will be able to effectively monitor daily step count. A health coach will receive more this detailed data and will guide weekly health coaching sessions designed to increase awareness of the physical activities completed and ignite inner motivation for healthy behaviors.
The proposed PR program is innovative and responds to an unmet need in chronic care for COPD patients in the context of COVID-19 pandemic and it mitigates the common accessibility barriers.
Detailed description
Specific aims will guide the proposed project:
- Aim 1: To determine the feasibility of the proposed home-based PR program. We will additionally address adherence and appropriateness of the program.
- Aim 2: To determine improvements in quality of life and mental health of the proposed home-based PR determined.
- Aim 3: To evaluate if the average number of daily step counts increase after the home-based PR program
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- starting with a small pilot and will follow with parallell design RCT - starting later
| Arm | Type | Receives |
|---|---|---|
| Home based exercise | Experimental | Behavioral: Home based exerciseHome based exercise with health coaching |
| Usual care | No intervention | –Usual care, waiting list |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women age 40 years and older
- FEV1 <80% or less (forced expiratory volume in one second) as documented by pulmonary function.
- Medical diagnosis of COPD, GOLD classification B,D, and C based on symptoms and history of exacerbations.
- The patients must be able to access a smart-phone or computer tablet with internet service.
Key exclusion criteria (3 listed)
- Unable to perform low intensity exercise.
- Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move, are not living in the healthcare area.
- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
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 |
|---|---|---|
| Home based exerciseExercise at home and behavioural change to increase daily exercise | Behavioural | Home based exercise |
Primary outcome
Disease specific quality of life
Time frame: 8-12 weeks
Chronic Respiratory Questionnaire (CRQ)
Modified Medical Research Council Dyspnea scale (mMRC),
Time frame: 8-12 weeks
Dyspnea
COPD assessment Test (CAT)
Time frame: 8-12 weeks
assess symptoms of breathing
3 secondary outcomes
GAD to asses anxiety and depression symptoms
Time frame: 8-12 weeks
Online breathing and mindful movement exercises/ exercise routine
Time frame: 8-12 weeks
Activity monitoring
Time frame: 8-12 weeks
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 26 Jun 2026.
- Results publication: PubMed 37811474Benzo MV, Hagstromer M, Nygren-Bonnier M, Benzo RP, Papp ME. Home-Based Physical Activity Program With Health Coaching for participants With Chronic Obstructive Pulmonary Disease in Sweden: A Proof-of-Concept Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2023 Sep 30;7(5):470-475. doi: 10.1016/j.mayocpiqo.2023.07.005. eCollection 2023 Oct.
- Home-Based Physical Activity Program With Health Coaching for participants With Chronic Obstructive Pulmonary Disease in Sweden: A Proof-of-Concept Pilot StudyLink provided by the sponsor.
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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.
Marian Papp, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based exercise in people with COPD, Chronic Obstructive Pulmonary Disease, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Contact Marian Papp, PhD (+46706946553, marian.papp@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease specific quality of life (time frame: 8-12 weeks). 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?
On the ClinicalTrials.gov record for NCT04820257, 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 26 Jun 2026.