Pulmonary Rehabilitation for Rural Patients With COPD
Decreasing Disparity in Lung Disease: Pulmonary Rehabilitation for Rural Patients With COPD
2 other identifiers
interventional
306
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
April 17, 2025
April 1, 2025
4.4 years
February 21, 2025
April 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 3 months
Study Arms (2)
Treatment Group
EXPERIMENTALSubjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately.
Waitlist Control
EXPERIMENTALSubjects randomized to the waitlist control (usual care) arm will be offered the home-based pulmonary rehabilitation intervention after completing the 12-week control period.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (2)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Benzo, M.D.
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Teng Moua, M.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 21, 2025
First Posted
February 26, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
April 17, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share