Chronic Obstructive Pulmonary Disease (COPDNCT06847061
Pulmonary Rehabilitation for Rural Patients With COPD
A study testing Pulmonary rehabilitation program in people with Chronic Obstructive Pulmonary Disease (COPD, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD
- What is being tested?
- Pulmonary rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2025to 31 Aug 2029
- 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
- 40 years of age or older
- Physician-diagnosed COPD
- Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10
- mMRC score>=1
- English Speaking
Who cannot join
- Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
- Cognitive impairment or inability to understand and follow instructions.
- Patients with no COPD symptom burden, no breathlessness (mMRC score 0), as based on our previous studies they usually perceive no benefit from PR and do not have compliance with PR.
- Traditional center-based PR was completed within 3 months of initial study recruitment.
- Transition to hospice or end-of-life care at the time of screening.
- Acute exacerbation at the time of screening.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Teng Moua, M.D.
Teng Moua, M.D.
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Roberto P Benzo, M.D.
Roberto P Benzo
About this study
Official title: Decreasing Disparity in Lung Disease: Pulmonary Rehabilitation for Rural Patients With COPD
The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.
- Being tested
- Pulmonary rehabilitation program
- 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 rehabilitation programBehavioural
Participants are expected to engage in the home-based pulmonary rehabilitation routine at least 24 minutes a day, five to six days a week for the entire 12-week study period.
The pulmonary rehabilitation routine begins with slow upper body and timed breathing exercises, followed by two slow balance walks for 6 minutes each. The total exercise time again is 24 minutes, followed by a 4-minute mindful breathing meditation/cool down
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately. Receives: Behavioral: Pulmonary rehabilitation program |
| Waitlist Control | Experimental | Subjects randomized to the waitlist control (usual care) arm will be offered the home-based pulmonary rehabilitation intervention after completing the 12-week control period. Receives: Behavioral: Pulmonary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Chronic Respiratory Questionnaire Physical and Emotional (CRQ-SAS) summary scores
The Chronic Respiratory Disease Questionnaire is a 20 item questionnaire assessing the quality of life for patients with chronic obstructive pulmonary disease (COPD).
The CRQ covers four domains: dyspnea, fatigue, emotional function, and mastery. Questions are scored on a 7-point Likert scale, with 1 representing 'All of the time' and 7 representing 'None of the time'. Higher scores indicate better outcomes.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Apr 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPDStudies 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
- This study design is control/Wait.
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto Benzo, M.D., Principal investigator, Mayo ClinicTeng Moua, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847061
- Sponsor's protocol ID
- 24-008332
- Other IDs
- 1R01NR021634-01
- Status last verified
- May 2026
- First submitted
- 21 Feb 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Disparity in Lung Disease: Pulmonary Rehabilitation for Rural Patients With COPD
- ClinicalTrials.gov ID
- NCT06847061
- Acronym / sponsor ID
- 24-008332
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 26 Feb 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 purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study design is control/Wait.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Pulmonary rehabilitation programSubjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately. |
| Waitlist Control | Experimental | Behavioral: Pulmonary rehabilitation programSubjects randomized to the waitlist control (usual care) arm will be offered the home-based pulmonary rehabilitation intervention after completing the 12-week control period. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 40 years of age or older
- Physician-diagnosed COPD
- Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10
- mMRC score>=1
- English Speaking
Key exclusion criteria (6 listed)
- Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
- Cognitive impairment or inability to understand and follow instructions.
- Patients with no COPD symptom burden, no breathlessness (mMRC score 0), as based on our previous studies they usually perceive no benefit from PR and do not have compliance with PR.
- Traditional center-based PR was completed within 3 months of initial study recruitment.
- Transition to hospice or end-of-life care at the time of screening.
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 rehabilitation programParticipants are expected to engage in the home-based pulmonary rehabilitation routine at least 24 minutes a day, five to six days a week for the entire 12-week study period. The pulmonary rehabilitation routine begins with slow upper body and timed breathing exercises, followed by two slow balance walks for 6 minutes each. The total exercise time again is 24 minutes, followed by a 4-minute mindful breathing meditation/cool down | Behavioural | Treatment Group, Waitlist Control |
Primary outcome
Change Chronic Respiratory Questionnaire Physical and Emotional (CRQ-SAS) summary scores
Time frame: Baseline, 3 months
The Chronic Respiratory Disease Questionnaire is a 20 item questionnaire assessing the quality of life for patients with chronic obstructive pulmonary disease (COPD). The CRQ covers four domains: dyspnea, fatigue, emotional function, and mastery. Questions are scored on a 7-point Likert scale, with 1 representing 'All of the time' and 7 representing 'None of the time'. Higher scores indicate better outcomes.
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 7 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Roberto Benzo, M.D. principal investigator
Mayo Clinic
Teng Moua, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation program in people with Chronic Obstructive Pulmonary Disease (COPD, run by Mayo Clinic at 2 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 6 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 7 May 2026. 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 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?
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 Johanna Hoult, M.A. (507-293-1989, Hoult.Johanna@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Chronic Respiratory Questionnaire Physical and Emotional (CRQ-SAS) summary scores (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?
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 7 May 2026.