Home Pulmonary Rehabilitation for COPD

NCT ID: NCT03480386

Last Updated: 2024-02-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-02-16

Brief Summary

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Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD) Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume \[FEV1\] \<50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale \[mMRC\] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pulmonary Rehabilitation Program Intervention

Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching.

Group Type EXPERIMENTAL

Home Based Pulmonary Rehabilitation

Intervention Type BEHAVIORAL

Twice daily exercise routine six days a week of 3 minutes of personal breathing, 5 exercises with 10 reps each, and 6 minutes of walking with weekly health coach calls.

Usual Care

Subjects will receive 12 weeks of usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home Based Pulmonary Rehabilitation

Twice daily exercise routine six days a week of 3 minutes of personal breathing, 5 exercises with 10 reps each, and 6 minutes of walking with weekly health coach calls.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of COPD, confirmed by spirometry
* Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
* Current or previous smoker (≥10 packs per year)
* Confidence in using the proposed pulmonary rehabilitation (PR) system
* English language fluency

Exclusion Criteria

* Study candidate experiencing an acute COPD exacerbation (can be included after the acute event)
* Inability to walk (orthopedic-neurologic problems or confined to a bed)
* Currently in PR or finished PR in the last three months (unlikely to improve)
* Pregnant women
* Live in an area where cell phones do not work/
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

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 P Benzo

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Health Partners

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Benzo R, Hoult J, McEvoy C, Clark M, Benzo M, Johnson M, Novotny P. Promoting Chronic Obstructive Pulmonary Disease Wellness through Remote Monitoring and Health Coaching: A Clinical Trial. Ann Am Thorac Soc. 2022 Nov;19(11):1808-1817. doi: 10.1513/AnnalsATS.202203-214OC.

Reference Type RESULT
PMID: 35914215 (View on PubMed)

Benzo M, Lee M, Clark MM, Benzo R. The Basic Science of Behavior Change in COPD: Testing Self-Determination Theory to Support Home-Based Rehabilitation With Health Coaching. J Cardiopulm Rehabil Prev. 2025 Jul 1;45(4):286-293. doi: 10.1097/HCR.0000000000000957. Epub 2025 Jun 26.

Reference Type DERIVED
PMID: 40476761 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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R01HL140486-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-009449

Identifier Type: -

Identifier Source: org_study_id

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