Trial Outcomes & Findings for A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients (NCT NCT05349123)
NCT ID: NCT05349123
Last Updated: 2025-06-06
Results Overview
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.
COMPLETED
NA
99 participants
baseline, 3 months, 6 months
2025-06-06
Participant Flow
Participant milestones
| Measure |
Intervention
Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module
|
Control
Home-based pulmonary rehabilitation that includes health coaching
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Baseline characteristics by cohort
| Measure |
Intervention
n=48 Participants
Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module
|
Control
n=51 Participants
Home-based pulmonary rehabilitation that includes health coaching
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.551 years
STANDARD_DEVIATION 6.894 • n=99 Participants
|
70.103 years
STANDARD_DEVIATION 8.922 • n=107 Participants
|
69.832 years
STANDARD_DEVIATION 7.957 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Afghanistan
|
48 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=29 Participants
Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module
|
Control
n=25 Participants
Home-based pulmonary rehabilitation that includes health coaching
|
|---|---|---|
|
Breathlessness
baseline, 3 months
|
0.68 score on a scale
Interval 0.36 to 1.0
|
0.71 score on a scale
Interval 0.19 to 1.22
|
|
Breathlessness
baseline, 6 months
|
0.34 score on a scale
Interval -0.03 to 0.71
|
0.83 score on a scale
Interval 0.11 to 1.55
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=29 Participants
Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module
|
Control
n=26 Participants
Home-based pulmonary rehabilitation that includes health coaching
|
|---|---|---|
|
Emotion
baseline, 3 months
|
0.45 score on a scale
Interval 0.01 to 0.88
|
0.55 score on a scale
Interval 0.14 to 0.97
|
|
Emotion
baseline, 6 months
|
0.35 score on a scale
Interval 0.04 to 0.66
|
0.5 score on a scale
Interval -0.07 to 1.06
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: 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.
Physical activity as measured by the ActiGraph, primarily daily steps
Outcome measures
| Measure |
Intervention
n=27 Participants
Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module
|
Control
n=26 Participants
Home-based pulmonary rehabilitation that includes health coaching
|
|---|---|---|
|
Physical Activity
baseline, 3 months
|
765.98 steps per day
Interval 46.16 to 1485.79
|
701.5 steps per day
Interval -49.43 to 1452.43
|
|
Physical Activity
baseline, 6 months
|
-181.78 steps per day
Interval -987.65 to 624.09
|
290.36 steps per day
Interval -537.44 to 1118.17
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place