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Trial record 14 of 54 for:    COPD OR COPD OR chronic obstructive pulmonary disease OR chronic bronchitis OR emphysema | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Home Pulmonary Rehabilitation for COPD

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ClinicalTrials.gov Identifier: NCT03480386
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Brief Summary:

While pulmonary rehabilitation provides benefits to people with COPD, only 1.5% have access to pulmonary rehabilitation each year. The main barriers are related to travel and transportation. This protocol will evaluate the effect of a home-based rehabilitation system on quality of life and steps. The system allows for monitoring by a health care system. A health coach will review the data and provide coaching to facilitate behavioral change and self-efficacy.

Patients will be randomized to 1 of 2 groups.


Condition or disease Intervention/treatment Phase
COPD Emphysema Behavioral: Home Based Pulmonary Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Home Pulmonary Rehabilitation for COPD
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Intervention
Patients randomized in this arm will start with the home based pulmonary rehabilitation exercises.
Behavioral: Home Based Pulmonary Rehabilitation
The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.

Placebo Comparator: Control
Patients randomized in this arm will start the exercises in 12 weeks.
Behavioral: Home Based Pulmonary Rehabilitation
The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.




Primary Outcome Measures :
  1. Participants on home-based PR will have higher quality of life at month three after randomization than participants in the waitlist control group. [ Time Frame: baseline, 3 months. ]
    Participants will complete quality of life questionnaires at enrollment and at 3 months. The Chronic Respiratory Questionnaire (CRQ) will be utilized to measure quality of life. The intervention participants will have a change in quality of life.


Secondary Outcome Measures :
  1. Daily Physical Activity will be measured and compared between baseline and three months [ Time Frame: baseline and 3 months ]
    Actigraph GT3X is the validated tool to measure physical activity. The Actigraph will be worn for one week to measures sedentary time. Sedentary time will be higher in the controlled group after the intervention



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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Clinical diagnosis of COPD,
  • Age ≥40 years
  • Current or previous smoker (≥10 packs per year)
  • Confidence in using the proposed PR system
  • English or Spanish language fluency

Exclusion Criteria

  • Unable or unwilling to do Rehabilitation due to physical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480386


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Robert Crews    904-953-9559    crews.robert@mayo.edu   
United States, Minnesota
Health Partners Not yet recruiting
Minneapolis, Minnesota, United States, 55122
Contact: Charlene McEvoy, MD         
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Johanna Hoult, MA    507-293-1989    hoult.johanna@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Roberto P Benzo Mayo Clinic

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Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03480386     History of Changes
Other Study ID Numbers: 17-009449
R01HL140486-01 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto P. Benzo, Mayo Clinic:
Pulmonary Rehabilitation
Additional relevant MeSH terms:
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Emphysema
Pathologic Processes