Chronic Obstructive Pulmonary Disease (COPD)NCT03480386
Home Pulmonary Rehabilitation for COPD
A study testing Home Based Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD) and Emphysema, run by Mayo Clinic at 3 sites in United States.
Trial summary
Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Emphysema
- What is being tested?
- Home Based Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2019to 16 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD, confirmed by spirometry
- Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
- Current or previous smoker (≥10 packs per year)
- Confidence in using the proposed pulmonary rehabilitation (PR) system
- English language fluency
Who cannot join
- Study candidate experiencing an acute COPD exacerbation (can be included after the acute event)
- Inability to walk (orthopedic-neurologic problems or confined to a bed)
- Currently in PR or finished PR in the last three months (unlikely to improve)
- Pregnant women
- Live in an area where cell phones do not work/
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Health Partners
Minneapolis, Minnesota, 55122
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.
- Being tested
- Home Based Pulmonary Rehabilitation
- Keywords
- Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Pulmonary RehabilitationBehavioural
Twice daily exercise routine six days a week of 3 minutes of personal breathing, 5 exercises with 10 reps each, and 6 minutes of walking with weekly health coach calls.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Experimental | Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. Receives: Behavioral: Home Based Pulmonary Rehabilitation |
| Usual Care | No intervention | Subjects will receive 12 weeks of usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
The Chronic Respiratory Questionnaire (CRQ) is a validated tool, completed by participants at baseline and 3 months and measured health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. All scores have a range of 1 to 7, a higher number being better health-related quality of life. We reported the difference between baseline and 3 months on the CRQ emotional summary score (comprised of the mastery and emotional domains) and the physical summary score (comprised of dyspnea and fatigue domains). 0.5 points is the minimal clinically important difference for this tool.
Measured: Baseline, 3 months
Secondary outcomes (9)
Change in Self-management Abilities
Measured using the Self-Management Ability Scale-30 item questionnaire to assess ability and function. The SMAS consists of 30 items on four- and five-point Likert scales. Total score ranging from 0 to 100 with higher score indicating a higher function and ability, better outcome.
Measured: Baseline, 3 months
Change in Physical Activity
The change in average daily activity (measured in minutes) for the top 3 to 5 most active days during the measured period. Measured by the Actigraph GT3X .
Measured: Baseline, 3 months
Change in Daily Step Counts
Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count.
Measured: Baseline, 3 months
Change in Depression
Measured by the Patient Health Questionnaire-9 item questionnaire screening for depression. Total score range from 0 to 27. A higher score indicates that depression may be present.
Measured: Baseline, 3 months
Social Support
Measured by the Interpersonal Support Evaluation List (ISEL-12) a 12-item measure of perceptions of social support utilizing three different subscales designed to measure three dimensions of f perceived social support (appraisal support, beloning support, and tangible support). Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". Total score range 0-36 with a higher score indicating greater social support.
Measured: Baseline, 3 months
Meaning in Life
Meaning in Life Questionnaire- 10 item questionnaire measuring the purpose, meaning and presence in life. A higher score indicates a perception of higher meaning and purpose. Scores range from 10-70, a higher score indicates a high perceived meaning and purpose in the respondents life.
Measured: Baseline, 3 months
Change in Sleep Quality
Measured using the Pittsburgh Sleep Quality Index to assess severity of sleep disturbances. 9 item questionnaire with total possible scores range from 0 to 21. A lower score suggests a better quality of sleep and a higher score indicates a worse outcome/more severe symptoms of disturbance.
Measured: Baseline, 3 months
Change in Anxiety
Measured using the General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0 to 6.,A higher score suggests that anxiety is present.
Measured: Baseline, 3 months
Healthcare Utilization
Number of subjects to have an emergency room visits or hospitalization.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Jan 2019
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume \[FEV1\] \<50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale \[mMRC\] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto P Benzo, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480386
- Sponsor's protocol ID
- 17-009449
- Other IDs
- R01HL140486-01
- Status last verified
- Jan 2024
- First submitted
- 26 Feb 2018
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benzo R, Hoult J, McEvoy C, Clark M, Benzo M, Johnson M, Novotny P. Promoting Chronic Obstructive Pulmonary Disease Wellness through Remote Monitoring and Health Coaching: A Clinical Trial. Ann Am Thorac Soc. 2022 Nov;19(11):1808-1817. doi: 10.1513/AnnalsATS.202203-214OC.
PubMed 35914215Benzo M, Lee M, Clark MM, Benzo R. The Basic Science of Behavior Change in COPD: Testing Self-Determination Theory to Support Home-Based Rehabilitation With Health Coaching. J Cardiopulm Rehabil Prev. 2025 Jul 1;45(4):286-293. doi: 10.1097/HCR.0000000000000957. Epub 2025 Jun 26.
PubMed 40476761
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Pulmonary Rehabilitation for COPD
- ClinicalTrials.gov ID
- NCT03480386
- Acronym / sponsor ID
- 17-009449
- Keywords
- Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 13 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume [FEV1] <50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale [mMRC] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Experimental | Behavioral: Home Based Pulmonary RehabilitationSubjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. |
| Usual Care | No intervention | –Subjects will receive 12 weeks of usual care. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of COPD, confirmed by spirometry
- Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
- Current or previous smoker (≥10 packs per year)
- Confidence in using the proposed pulmonary rehabilitation (PR) system
- English language fluency
Key exclusion criteria (5 listed)
- Study candidate experiencing an acute COPD exacerbation (can be included after the acute event)
- Inability to walk (orthopedic-neurologic problems or confined to a bed)
- Currently in PR or finished PR in the last three months (unlikely to improve)
- Pregnant women
- Live in an area where cell phones do not work/
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 Pulmonary RehabilitationTwice daily exercise routine six days a week of 3 minutes of personal breathing, 5 exercises with 10 reps each, and 6 minutes of walking with weekly health coach calls. | Behavioural | Pulmonary Rehabilitation Program Intervention |
Primary outcome
Change in Quality of Life
Time frame: Baseline, 3 months
The Chronic Respiratory Questionnaire (CRQ) is a validated tool, completed by participants at baseline and 3 months and measured health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. All scores have a range of 1 to 7, a higher number being better health-related quality of life. We reported the difference between baseline and 3 months on the CRQ emotional summary score (comprised of the mastery and emotional domains) and the physical summary score (comprised of dyspnea and fatigue domains). 0.5 points is the minimal clinically important difference for this tool.
9 secondary outcomes
Change in Self-management Abilities
Time frame: Baseline, 3 months
Change in Physical Activity
Time frame: Baseline, 3 months
Change in Daily Step Counts
Time frame: Baseline, 3 months
Change in Depression
Time frame: Baseline, 3 months
Social Support
Time frame: Baseline, 3 months
Meaning in Life
Time frame: Baseline, 3 months
Change in Sleep Quality
Time frame: Baseline, 3 months
Change in Anxiety
Time frame: Baseline, 3 months
Healthcare Utilization
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35914215Benzo R, Hoult J, McEvoy C, Clark M, Benzo M, Johnson M, Novotny P. Promoting Chronic Obstructive Pulmonary Disease Wellness through Remote Monitoring and Health Coaching: A Clinical Trial. Ann Am Thorac Soc. 2022 Nov;19(11):1808-1817. doi: 10.1513/AnnalsATS.202203-214OC.
- Derived from this study: PubMed 40476761Benzo M, Lee M, Clark MM, Benzo R. The Basic Science of Behavior Change in COPD: Testing Self-Determination Theory to Support Home-Based Rehabilitation With Health Coaching. J Cardiopulm Rehabil Prev. 2025 Jul 1;45(4):286-293. doi: 10.1097/HCR.0000000000000957. Epub 2025 Jun 26.
- Mayo Clinic Clinical TrialsLink 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. This study is not recruiting at the moment.
Roberto P Benzo principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD) and Emphysema, run by Mayo Clinic at 3 sites in United States.
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 5 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: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Quality of Life (time frame: Baseline, 3 months). 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 NCT03480386, which also lists 2 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 13 Feb 2024.