An interventional study of Mindful Breathing and Home-Based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease, sponsored by Minnesota HealthSolutions. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Minnesota HealthSolutions · Not applicable, Interventional, and Supportive care
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).
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 99 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Minnesota HealthSolutions is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module
Behavioral: Mindful Breathing · Behavioral: Home-Based Pulmonary Rehabilitation
Home-based pulmonary rehabilitation that includes health coaching
Behavioral: Home-Based Pulmonary Rehabilitation
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.
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.
Also known as: Health Coaching
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
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
Physical Activity
Physical activity as measured by the ActiGraph, primarily daily steps
Time frame: baseline, 3 months, 6 months
| Milestone | Intervention | Control |
|---|---|---|
| Started | 48 | 51 |
| Completed | 48 | 51 |
| Not completed | 0 | 0 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| baseline, 3 months | 0.68 (0.36 to 1.0) | 0.71 (0.19 to 1.22) |
| baseline, 6 months | 0.34 (-0.03 to 0.71) | 0.83 (0.11 to 1.55) |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| baseline, 3 months | 0.45 (0.01 to 0.88) | 0.55 (0.14 to 0.97) |
| baseline, 6 months | 0.35 (0.04 to 0.66) | 0.5 (-0.07 to 1.06) |
Physical activity as measured by the ActiGraph, primarily daily steps
| steps per day | Intervention | Control |
|---|---|---|
| baseline, 3 months | 765.98 (46.16 to 1485.79) | 701.5 (-49.43 to 1452.43) |
| baseline, 6 months | -181.78 (-987.65 to 624.09) | 290.36 (-537.44 to 1118.17) |
Collected over Adverse events were collected from baseline to end of study, approximately six months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Control | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 69.551 ± 6.894 | 70.103 ± 8.922 | 69.832 ± 7.957 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 29 | 29 | 58 |
| Male | 19 | 22 | 41 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 45 | 48 | 93 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 47 | 50 | 97 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Afghanistan | 48 | 51 | 99 |
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