Home Pulmonary Rehabilitation for COPD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03480386 |
Recruitment Status :
Completed
First Posted : March 29, 2018
Last Update Posted : October 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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COPD Emphysema | Behavioral: Home Based Pulmonary Rehabilitation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | September 23, 2022 |
Actual Study Completion Date : | September 23, 2022 |

Arm | Intervention/treatment |
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Experimental: Intervention
Patients randomized in this arm will start with the home based pulmonary rehabilitation program.
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Behavioral: Home Based Pulmonary Rehabilitation
The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach. |
Active Comparator: Control
Patients randomized in this arm will start the intervention after 12 weeks of usual care.
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Behavioral: Home Based Pulmonary Rehabilitation
The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach. |
- 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.
- 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, daily step, and time in sedentary mode, and mild-moderate and vigorous physical activity.
- Self-Management [ Time Frame: baseline and 3 months ]Self-Management Ability Scale-30 item questionnaire measuring ability and function. A higher score indicates higher function and ability.The SMAS consists of 30 items on four- and five-point Likert scales. Scores on the subscales and the total score are transformed into scores ranging from 0 to 100 (higher number is best). Each question has a range from 1-5.
- Depression [ Time Frame: baseline and 3 months ]Patient Health Questionnaire-9 item questionnaire screening for depression. A higher score indicates that depression may be present. Scores range from 0-27.
- Social Support [ Time Frame: baseline and 3 months ]The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other.- 12 item questionnaire with a range of 12-84. A higher score indicates a greater amount of social support.
- Meaning in Life [ Time Frame: baseline and 3 month ]Meaning in Life Questionnaire- 10 item questionnaire measuring the purpose, meaning and presence in life. A higher score indicates a perception of higher meaning and purpose. Scores range from 10-70, a higher score indicates a high perceived meaning and purpose in the respondents life.
- Sleep Quality [ Time Frame: baseline and 3 month ]Sleep Quality Assessment - 9 item questionnaire measuring the quality and patterns of sleep. Scores range from 0 to 21. A lower score suggests a better quality of sleep.
- Anxiety [ Time Frame: baseline and 3 month ]General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0-6, a higher score suggests that anxiety is present.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Florida | |
Mayo Clinic in Florida | |
Jacksonville, Florida, United States, 32224 | |
United States, Minnesota | |
Health Partners | |
Minneapolis, Minnesota, United States, 55122 | |
Mayo Clinic in Rochester | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Roberto P Benzo | Mayo Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Roberto P. Benzo, Principal Investigator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT03480386 |
Other Study ID Numbers: |
17-009449 R01HL140486-01 ( U.S. NIH Grant/Contract ) |
First Posted: | March 29, 2018 Key Record Dates |
Last Update Posted: | October 13, 2022 |
Last Verified: | October 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Rehabilitation |
Emphysema Pathologic Processes |