Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALMindful Breathing
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.
BEHAVIORALHome-Based Pulmonary Rehabilitation
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.
Sponsors
Mayo Clinic
Minnesota HealthSolutions
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 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).
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be ≥40 years old * Patients must have a diagnosis COPD documented by pulmonary function testing; breathlessness of score 2 or higher by the Medical Research Council Score * Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking
Exclusion criteria
* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state; or are not living in the healthcare area * Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition) * Patients with an inability to do mild exercise (patients who have orthopedic-neurologic problems; patients who have severe heart failure, characterized by an ejection fraction of \<20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients in whom any physical activity brings on discomfort and in whom symptoms occur at rest).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathlessness | baseline, 3 months, 6 months | 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. |
| Emotion | baseline, 3 months, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | baseline, 3 months, 6 months | Physical activity as measured by the ActiGraph, primarily daily steps |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module | 48 |
| Control Home-based pulmonary rehabilitation that includes health coaching | 51 |
| Total | 99 |
Baseline characteristics
| Characteristic | Total | Intervention | Control |
|---|---|---|---|
| Age, Continuous | 69.832 years STANDARD_DEVIATION 7.957 | 69.551 years STANDARD_DEVIATION 6.894 | 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 | 97 Participants | 47 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 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 | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 93 Participants | 45 Participants | 48 Participants |
| Region of Enrollment Afghanistan | 99 Participants | 48 Participants | 51 Participants |
| Sex: Female, Male Female | 58 Participants | 29 Participants | 29 Participants |
| Sex: Female, Male Male | 41 Participants | 19 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
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.
Time frame: baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Breathlessness | baseline, 3 months | 0.68 score on a scale |
| Intervention | Breathlessness | baseline, 6 months | 0.34 score on a scale |
| Control | Breathlessness | baseline, 3 months | 0.71 score on a scale |
| Control | Breathlessness | baseline, 6 months | 0.83 score on a scale |
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.
Time frame: baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Emotion | baseline, 3 months | 0.45 score on a scale |
| Intervention | Emotion | baseline, 6 months | 0.35 score on a scale |
| Control | Emotion | baseline, 3 months | 0.55 score on a scale |
| Control | Emotion | baseline, 6 months | 0.5 score on a scale |
Secondary
Physical Activity
Physical activity as measured by the ActiGraph, primarily daily steps
Time frame: baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Physical Activity | baseline, 3 months | 765.98 steps per day |
| Intervention | Physical Activity | baseline, 6 months | -181.78 steps per day |
| Control | Physical Activity | baseline, 3 months | 701.5 steps per day |
| Control | Physical Activity | baseline, 6 months | 290.36 steps per day |