Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
306 participants
INTERVENTIONAL
2025-04-01
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment Group
Subjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately.
Pulmonary rehabilitation program
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
Waitlist Control
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.
Pulmonary rehabilitation program
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
Interventions
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Pulmonary rehabilitation program
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
Eligibility Criteria
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Inclusion Criteria
* Physician-diagnosed COPD
* Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10
* mMRC score\>=1
* English Speaking
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Mayo Clinic
OTHER
Responsible Party
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Roberto P. Benzo
Principal Investigator
Principal Investigators
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Roberto Benzo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Teng Moua, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Roberto P Benzo, M.D.
Role: primary
Teng Moua, M.D.
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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24-008332
Identifier Type: -
Identifier Source: org_study_id
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