COPD
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Subjects will wear an activity monitor while doing at home exercises using a computer tablet
BEHAVIORALMindful breathing module
Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.
BEHAVIORALHealth coaching
Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Minnesota HealthSolutions
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults, age ≥ 40 years old. * Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD). * At least 10 pack years of smoking.
Exclusion criteria
* Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed). * Unable to follow commands (cognitive impairment). * Have a high likelihood of being lost to follow-up (active alcohol or drug abuse). * Live in an area that does not have cellular service (Verizon).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score | Baseline, 3 months, 6 months | 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. |
| Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score | baseline, 3 months, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Physical Activity | baseline, 3 months, 6 months | Mean change in the number of steps per day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 48 |
| 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 | 51 |
| Total | 99 |
Baseline characteristics
| Characteristic | Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Total | Home-base Pulmonary Rehabilitation |
|---|---|---|---|
| Age, Continuous | 69.551 years STANDARD_DEVIATION 6.894 | 69.832 years STANDARD_DEVIATION 7.957 | 70.103 years STANDARD_DEVIATION 8.922 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 97 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 45 Participants | 93 Participants | 48 Participants |
| Region of Enrollment United States | 48 participants | 99 participants | 51 participants |
| Sex: Female, Male Female | 29 Participants | 58 Participants | 29 Participants |
| Sex: Female, Male Male | 19 Participants | 41 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 51 |
| other Total, other adverse events | 0 / 48 | 0 / 51 |
| serious Total, serious adverse events | 0 / 48 | 0 / 51 |
Outcome results
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.
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score | baseline, 3 months | 0.68 score on a scale |
| Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score | baseline, 6 months | 0.34 score on a scale |
| Home-base Pulmonary Rehabilitation | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score | baseline, 3 months | 0.71 score on a scale |
| Home-base Pulmonary Rehabilitation | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score | baseline, 6 months | 0.83 score on a scale |
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.
Time frame: baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score | baseline, 3 months | 0.45 score on a scale |
| Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score | baseline, 6 months | 0.35 score on a scale |
| Home-base Pulmonary Rehabilitation | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score | baseline, 3 months | 0.55 score on a scale |
| Home-base Pulmonary Rehabilitation | Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score | baseline, 6 months | 0.5 score on a scale |
Secondary
Change in Daily Physical Activity
Mean change in the number of steps per day
Time frame: baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Change in Daily Physical Activity | baseline, 6 months | -181.78 steps per day |
| Home-base Pulmonary Rehabilitation With Mindful Breathing Module | Change in Daily Physical Activity | baseline, 3 months | 765.98 steps per day |
| Home-base Pulmonary Rehabilitation | Change in Daily Physical Activity | baseline, 3 months | 701.5 steps per day |
| Home-base Pulmonary Rehabilitation | Change in Daily Physical Activity | baseline, 6 months | 290.36 steps per day |