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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44AT009665-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Minnesota HealthSolutions | INDUSTRY |
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The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.
A breathing technique called Pursed Lipped Breathing (PLB) has been proven to be beneficial for patients with COPD. PLB can ease shortness of breath and reduce stress and anxiety. This study will develop a mindful PLB module to compliment an already developed home based pulmonary rehabilitation program. In this study, patients will be randomized to either a group that does the home based pulmonary rehabilitation with the mindful breathing module and health coaching or a group that does the home based pulmonary rehabilitation with health coaching without the mindful breathing module. Both groups will do the home based pulmonary rehabilitation for 12 weeks. In addition there are questionnaires and the wearing of an activity monitor when you sign up and at 3 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-base pulmonary rehabilitation with mindful breathing modu | Experimental | Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet. |
|
| Home-base pulmonary rehabilitation | Active Comparator | Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based pulmonary rehabilitation program | Behavioral | Subjects will wear an activity monitor while doing at home exercises using a computer tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score | The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea. | Baseline, 3 months, 6 months |
| Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score | The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 (All of the time) to 7 (None of the time). Total scores range from 7-49. Lower scores indicate more severity of emotions. Higher scores indicate less severity of emotions. | baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Physical Activity | Mean change in the number of steps per day | baseline, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto P Benzo | Mayo Clinic | Principal Investigator |
| Kevin Kramer, PhD | Minnesota HealthSolutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota HealthSolutions Corporporation | Minneapolis | Minnesota | 55414 | United States | ||
| Mayo Clinic in Rochester |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet. Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen. Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing |
| FG001 | Home-base Pulmonary Rehabilitation | Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet. Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen. Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing |
| Units | Counts |
|---|---|
| Participants |
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| 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 Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score | The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea. | For the Home-based pulmonary rehabilitation 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 Home-base pulmonary rehabilitation arm, 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 |
|
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 | Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet. Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen. Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto P. Benzo, M.D. | 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 | Jun 8, 2021 | Jul 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Half of the participants will be randomized to receive the home-based PR with the mindful breathing module which consists of the Pursed Lipped Breathing Application and the Spire Health Tags (intervention) and half will receive the home-based PR (control).
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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.
| Mindful breathing module | Behavioral | Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen. |
|
| Health coaching | Behavioral | Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| BG001 | Home-base Pulmonary Rehabilitation | Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet. Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen. Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing |
| OG001 | Home-base Pulmonary Rehabilitation | Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing |
|
|
| Primary | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score | The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 (All of the time) to 7 (None of the time). Total scores range from 7-49. Lower scores indicate more severity of emotions. Higher scores indicate less severity of emotions. | For the Home-based pulmonary rehabilitation 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 Home-base pulmonary rehabilitation arm, 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 |
|
|
|
| Secondary | Change in Daily Physical Activity | Mean change in the number of steps per day | For the Home-based pulmonary rehabilitation 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 Home-base pulmonary rehabilitation arm, 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 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Home-base Pulmonary Rehabilitation | Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing | 0 | 51 | 0 | 51 | 0 | 51 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| baseline, 6 months |
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