Pulmonary Rehabilitation for Rural Patients With COPD

NCT ID: NCT06847061

Last Updated: 2025-04-17

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study design is control/Wait.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment Group

Subjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately.

Group Type EXPERIMENTAL

Pulmonary rehabilitation program

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Pulmonary rehabilitation program

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Roberto P. Benzo

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Johanna Hoult, M.A.

Role: CONTACT

507-293-1989

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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Other Identifiers

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1R01NR021634-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-008332

Identifier Type: -

Identifier Source: org_study_id

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