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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL140486-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Experimental | Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. |
|
| Usual Care | No Intervention | Subjects will receive 12 weeks of usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Based Pulmonary Rehabilitation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | The Chronic Respiratory Questionnaire (CRQ) is a validated tool, completed by participants at baseline and 3 months and measured health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. All scores have a range of 1 to 7, a higher number being better health-related quality of life. We reported the difference between baseline and 3 months on the CRQ emotional summary score (comprised of the mastery and emotional domains) and the physical summary score (comprised of dyspnea and fatigue domains). 0.5 points is the minimal clinically important difference for this tool. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-management Abilities | Measured using the Self-Management Ability Scale-30 item questionnaire to assess ability and function. The SMAS consists of 30 items on four- and five-point Likert scales. Total score ranging from 0 to 100 with higher score indicating a higher function and ability, better outcome. | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto P Benzo | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States | ||
| Health Partners |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35914215 | Result | 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. | |
| 40476761 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Rehabilitation Program Intervention | Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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. |
| FG001 | Usual Care | Subjects will receive 12 weeks of usual care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Rehabilitation Program Intervention | Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality of Life | The Chronic Respiratory Questionnaire (CRQ) is a validated tool, completed by participants at baseline and 3 months and measured health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. All scores have a range of 1 to 7, a higher number being better health-related quality of life. We reported the difference between baseline and 3 months on the CRQ emotional summary score (comprised of the mastery and emotional domains) and the physical summary score (comprised of dyspnea and fatigue domains). 0.5 points is the minimal clinically important difference for this tool. | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants.
This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulmonary Rehabilitation Program Intervention | Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization- COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto P. Benzo, MD | Mayo Clinic | 507-284-0561 | Benzo.Roberto@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2021 | Dec 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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.
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| Change in Physical Activity |
The change in average daily activity (measured in minutes) for the top 3 to 5 most active days during the measured period. Measured by the Actigraph GT3X . |
| Baseline, 3 months |
| Change in Daily Step Counts | Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count. | Baseline, 3 months |
| Change in Depression | Measured by the Patient Health Questionnaire-9 item questionnaire screening for depression. Total score range from 0 to 27. A higher score indicates that depression may be present. | Baseline, 3 months |
| Social Support | Measured by the Interpersonal Support Evaluation List (ISEL-12) a 12-item measure of perceptions of social support utilizing three different subscales designed to measure three dimensions of f perceived social support (appraisal support, beloning support, and tangible support). Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". Total score range 0-36 with a higher score indicating greater social support. | Baseline, 3 months |
| Meaning in Life | 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. | Baseline, 3 months |
| Change in Sleep Quality | Measured using the Pittsburgh Sleep Quality Index to assess severity of sleep disturbances. 9 item questionnaire with total possible scores range from 0 to 21. A lower score suggests a better quality of sleep and a higher score indicates a worse outcome/more severe symptoms of disturbance. | Baseline, 3 months |
| Change in Anxiety | Measured using the General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0 to 6.,A higher score suggests that anxiety is present. | Baseline, 3 months |
| Healthcare Utilization | Number of subjects to have an emergency room visits or hospitalization. | 3 months |
| Minneapolis |
| Minnesota |
| 55122 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Death |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Complicating disease |
|
| Disease progression |
|
| Became ineligible |
|
| BG001 |
| Usual Care |
Subjects will receive 12 weeks of usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching.
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.
| OG001 | Usual Care | Subjects will receive 12 weeks of usual care. |
|
|
| Secondary | Change in Self-management Abilities | Measured using the Self-Management Ability Scale-30 item questionnaire to assess ability and function. The SMAS consists of 30 items on four- and five-point Likert scales. Total score ranging from 0 to 100 with higher score indicating a higher function and ability, better outcome. | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Physical Activity | The change in average daily activity (measured in minutes) for the top 3 to 5 most active days during the measured period. Measured by the Actigraph GT3X . | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | minutes | Baseline, 3 months |
|
|
|
|
| Secondary | Change in Daily Step Counts | Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count. | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | steps/day | Baseline, 3 months |
|
|
|
|
| Secondary | Change in Depression | Measured by the Patient Health Questionnaire-9 item questionnaire screening for depression. Total score range from 0 to 27. A higher score indicates that depression may be present. | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
|
| Secondary | Social Support | Measured by the Interpersonal Support Evaluation List (ISEL-12) a 12-item measure of perceptions of social support utilizing three different subscales designed to measure three dimensions of f perceived social support (appraisal support, beloning support, and tangible support). Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". Total score range 0-36 with a higher score indicating greater social support. | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
|
| Secondary | Meaning in Life | 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. | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
|
| Secondary | Change in Sleep Quality | Measured using the Pittsburgh Sleep Quality Index to assess severity of sleep disturbances. 9 item questionnaire with total possible scores range from 0 to 21. A lower score suggests a better quality of sleep and a higher score indicates a worse outcome/more severe symptoms of disturbance. | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
|
| Secondary | Change in Anxiety | Measured using the General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0 to 6.,A higher score suggests that anxiety is present. | Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
|
| Secondary | Healthcare Utilization | Number of subjects to have an emergency room visits or hospitalization. | 46 in the intervention arm were not included in the analysis, 27 withdrew consent, 18 did not complete measures at 3-month and 1 did not complete baseline measures. 45 in the usual care arm were not included in the analysis, 26 withdrew consent, 5 died, and 14 did not complete 3-month measures. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 188 |
| 15 |
| 188 |
| 0 |
| 188 |
| EG001 | Usual Care | Subjects will receive 12 weeks of usual care. | 5 | 187 | 15 | 187 | 0 | 187 |
| Hospitalization: Aortic Stenosis | Cardiac disorders | Systematic Assessment |
|
| Hospitalization: Opioid Hyperalgesia | General disorders | Systematic Assessment |
|
| Hospitalization- left Carotid Artery Stent | Vascular disorders | Systematic Assessment |
|
| Hospitalization: Debridement of Metatarsal ulcer | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization: Endobronchial valve lung volume reduction sugery | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalization: Obstruction Intestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization: Prostate Cancer | Reproductive system and breast disorders | Systematic Assessment |
|
| Hospitalization: Neoplasm of Rectum | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization: Malignant Neoplasm Brain | Nervous system disorders | Systematic Assessment |
|
| Hospitalization: Acute Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization: Pacemaker Cardiac Status Post | Cardiac disorders | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 0.0742 |
| Superiority |