Trial Outcomes & Findings for Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01577329)

NCT ID: NCT01577329

Last Updated: 2017-08-02

Results Overview

Breathing patterns will be measured at baseline using inductive plethysmography at baseline and at week eight. During that eight week time period the treatment group will have been exposed to a once a week mindfulness meditation class and the control group will have been exposed to health care as usual.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: baseline and at week eight
• Results posted on: 2017-08-02

Participant Flow

Change was made to original number of participants due to human error. 51 persons were approached regarding possible enrollment.

Participant milestones

Measure	Mindfulness Meditation Class Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned. Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.	Wait List Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
Overall Study STARTED	19	22
Overall Study COMPLETED	16	22
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Measure	Mindfulness Meditation Class n=19 Participants Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned. Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.	Wait List n=22 Participants Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Age, Continuous	70.3 years STANDARD_DEVIATION 5.2 • n=5 Participants	68.7 years STANDARD_DEVIATION 4.8 • n=7 Participants	69.5 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and at week eight

Breathing patterns will be measured at baseline using inductive plethysmography at baseline and at week eight. During that eight week time period the treatment group will have been exposed to a once a week mindfulness meditation class and the control group will have been exposed to health care as usual.

Outcome measures

Measure	Mindfulness Meditation Class n=16 Participants Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned. Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.	Wait List n=22 Participants Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
Changes in Respiratory Rate Baseline	15.93 Breaths per minute Standard Deviation 2.82	17.18 Breaths per minute Standard Deviation 6.44
Changes in Respiratory Rate Follow-up	21.31 Breaths per minute Standard Deviation 3.05	18.73 Breaths per minute Standard Deviation 4.31

Adverse Events

Mindfulness Meditation Class

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roxane Raffin Chan

University of Michigan

Phone: 7344780170

Email: roxchan@comcast.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place