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| Name | Class |
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| Mayo Clinic | OTHER |
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The Mindful Breathing Laboratory under the direction of Dr. Benzo will complete a randomized controlled trial to evaluate the mindful breathing module. This rigorous study will evaluate home-based PR system compared to the home-based PR system plus mindful breathing module for its effects on breathlessness and emotions. The investigators hypothesize that the intervention will decrease breathlessness while increasing emotional perception, emotional intelligence, and mindfulness.
A total of 50 adults diagnosed with COPD will be enrolled in this study. Half of the subjects will be randomized to receive home-based pulmonary rehabilitation with the mindful breathing module (intervention group) and half will receive home-based pulmonary rehabilitation (control group). Each subject will be consented and trained and then participate in either the intervention or control group. Both groups entail one week of baseline and twelve weeks of home-based pulmonary rehabilitation (health coaching plus activity monitoring). The intervention group will also receive the mindful breathing module during the twelve weeks of home-based pulmonary rehabilitation. The Chronic Respiratory Disease Questionnaire (CRQ) will be administered at baseline, week 12 (after the intervention) and week 24 as the investigators will follow the patients for 3 months after the intervention to document the sustainability of the effects (behavior change).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module |
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| Control | Active Comparator | Home-based pulmonary rehabilitation that includes health coaching |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Breathing | Behavioral | Subject will be expected to do 12 weeks of home-based rehabilitation, 6 days a week in their home. The proposed project explores the addition of a mindful breathing module, which involves daily guided breathing practice with feedback to encourage mindful breathing. |
| Measure | Description | Time Frame |
|---|---|---|
| Breathlessness | Breathlessness as measured by the Chronic Respiratory Disease Questionnaire. The Chronic Respiratory Disease Questionnaire is a 20-question inventory assessing four areas, including dyspnea (breathlessness). Patients rate their experience numerically on a 7-point modified Likert scale of 1 to7 with higher ratings indicating less symptom impairment. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more. | baseline, 3 months, 6 months |
| Emotion | Emotion as measured by the Chronic Respiratory Disease Questionnaire. The Chronic Respiratory Disease Questionnaire is a 20-question inventory assessing four areas, including emotion. Patients rate their experience numerically on a 7-point modified Likert scale of 1 to7 with higher ratings indicating less symptom impairment. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more. | baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Physical activity as measured by the ActiGraph, primarily daily steps | baseline, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module |
| FG001 | Control | Home-based pulmonary rehabilitation that includes health coaching |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 8, 2021 |
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Half of the subjects will be randomized to receive home-based PR with the mindful breathing module (intervention group) and half will receive home-based PR (control group).
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Since the patients will know if they have the Pursed Lipped Breathing Application and Spire tags, the outcome assessor will be blinded to which arm received the Application and tags.
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| Home-Based Pulmonary Rehabilitation | Behavioral | Subject will be asked to complete exercise guided by a video six days a week and to complete mindful walking six days per week. They will receive weekly health coaching calls. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module |
| BG001 | Control | Home-based pulmonary rehabilitation that includes health coaching |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Breathlessness | Breathlessness as measured by the Chronic Respiratory Disease Questionnaire. The Chronic Respiratory Disease Questionnaire is a 20-question inventory assessing four areas, including dyspnea (breathlessness). Patients rate their experience numerically on a 7-point modified Likert scale of 1 to7 with higher ratings indicating less symptom impairment. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more. | For the Intervention group with mindful breathing module arm, nineteen subjects did not complete the three months or six months questionnaire. Data was not collected or analyzed. For the Control group, twenty-six subjects did not complete the three months questionnaire and twenty-eight subjects did not complete the six months questionnaire. Data was not collected or analyzed. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 3 months, 6 months |
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| Primary | Emotion | Emotion as measured by the Chronic Respiratory Disease Questionnaire. The Chronic Respiratory Disease Questionnaire is a 20-question inventory assessing four areas, including emotion. Patients rate their experience numerically on a 7-point modified Likert scale of 1 to7 with higher ratings indicating less symptom impairment. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more. | For the Intervention group with mindful breathing module arm, nineteen subjects did not complete the three months or six months questionnaire. Data was not collected or analyzed. For the Control group, twenty-five subjects did not complete the three months questionnaire and twenty-eight subjects did not complete the six months questionnaire. Data was not collected or analyzed. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 3 months, 6 months |
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| Secondary | Physical Activity | Physical activity as measured by the ActiGraph, primarily daily steps | For the Intervention group with mindful breathing module arm, twenty-one subjects did not complete the three months or six months questionnaire. Data was not collected or analyzed. For the Control group, twenty-five subjects did not complete the three months questionnaire and thirty subjects did not complete the six months questionnaire. Data was not collected or analyzed. | Posted | Mean | 95% Confidence Interval | steps per day | baseline, 3 months, 6 months |
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Adverse events were collected from baseline to end of study, approximately six months
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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 | Intervention | Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module | 0 | 48 | 0 | 48 | 0 | 48 |
| EG001 | Control | Home-based pulmonary rehabilitation that includes health coaching | 0 | 51 | 0 | 51 | 0 | 51 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto P Benzo | Mayo Clinic | 507-284-0561 | benzo.roberto@mayo.edu |
| May 2, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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