Pulmonary Rehabilitation for Rural Patients With COPD
Decreasing Disparity in Lung Disease: Pulmonary Rehabilitation for Rural Patients With COPD
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johanna Hoult, M.A.
- Phone Number: 507-293-1989
- Email: Hoult.Johanna@mayo.edu
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Recruiting
- Mayo Clinic in Arizona
-
Contact:
- Roberto P Benzo, M.D.
-
Principal Investigator:
- Roberto P Benzo
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Teng Moua, M.D.
-
Principal Investigator:
- Teng Moua, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group
Subjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately.
|
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 |
|
Experimental: 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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline, 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Roberto Benzo, M.D., Mayo Clinic
- Principal Investigator: Teng Moua, M.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-008332
- 1R01NR021634-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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