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Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD)

Mindfulness Mediation Intervention in COPD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01577329
Enrollment
41
Registered
2012-04-13
Start date
2011-10-31
Completion date
2015-07-31
Last updated
2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

meditation, Chronic Obstructive Pulmonary Disease, Mindfulness, Anxiety, Breathing Patterns

Brief summary

The purpose of this study is to assess the feasibility and potential impact of an eight week program of meditation on expiratory time, anxiety and dyspnea in people with COPD.

Detailed description

Chronic Obstructive Pulmonary Disease is a progressive multi-dimensional disease with a complex network of somatic and affective components. Anxiety is a common experience for persons with COPD both as a reaction to dyspnea (48) and as a separate co-morbid condition (10, 26). The presence of anxiety magnifies COPD symptoms and further impairs physical functioning (53). Both anxiety and COPD alter breathing patterns similarly causing irregular rapid shallow breathing at rest, which is inefficient and cannot adequately respond to increases in ventilatory demands from physical or emotional activity (121). Both COPD and anxiety are also associated with changes in neurological functioning. Whereas anxiety tends to be associated with increased amygdala activity (54), COPD is associated with a decrease in frontal cortex functioning (25, 28, 122). Persons with COPD who experience anxiety are less able to correctly process the level of physical and emotional demand for any given situation and their ability to meet that demand (46, 123). Pulmonary rehabilitation addresses both the physical and emotional symptoms of COPD, however gains in function are quickly lost over time (4). Evidence suggests that mindfulness based meditation can alter neural pathways to facilitate processing of emotions and increase quality of life for persons with COPD. The overall objective of this study is to assess the ability of persons with COPD to participate in a mindfulness meditation intervention and to examine the impact of mindfulness meditation on their anxiety levels and global sense of coherence. A modified version of Antonovsky's sense of coherence model will be used as the framework for this study. We will address the specific aims: 1) to determine the effects of mindfulness meditation on breathing patterns; 2) To determine the effects of mindfulness meditation on anxiety levels; 3) To determine self-reported adherence rates following an eight-week small group instructional course on mindfulness meditation, and 4) To determine the effects of mindfulness meditation on global sense of coherence levels in persons with COPD. The National Center for Complementary and Alternative Medicine identifies meditation as a form of CAM that focuses on the interaction among the brain, body, mind and behavior that is already practiced by 8% of persons who participate in CAM therapy. Meditation is rated a special priority research area by NCCAM.

Interventions

BEHAVIORALMindfulness 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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Any stage of Chronic Obstructive Pulmonary Disease * Able to read and write English

Exclusion criteria

* Severe mental disability * Inability to attend

Design outcomes

Primary

MeasureTime frameDescription
Changes in Respiratory Ratebaseline and at week eightBreathing 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.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
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.
19
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.
22
Total41

Baseline characteristics

CharacteristicWait ListMindfulness Meditation ClassTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
21 Participants16 Participants37 Participants
Age, Categorical
Between 18 and 65 years
1 Participants3 Participants4 Participants
Age, Continuous68.7 years
STANDARD_DEVIATION 4.8
70.3 years
STANDARD_DEVIATION 5.2
69.5 years
STANDARD_DEVIATION 7.9
Region of Enrollment
United States
22 Participants19 Participants41 Participants
Sex: Female, Male
Female
14 Participants13 Participants27 Participants
Sex: Female, Male
Male
8 Participants6 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 22
other
Total, other adverse events
0 / 190 / 22
serious
Total, serious adverse events
0 / 190 / 22

Outcome results

Primary

Changes in Respiratory Rate

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.

Time frame: baseline and at week eight

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Meditation ClassChanges in Respiratory RateBaseline15.93 Breaths per minuteStandard Deviation 2.82
Mindfulness Meditation ClassChanges in Respiratory RateFollow-up21.31 Breaths per minuteStandard Deviation 3.05
Wait ListChanges in Respiratory RateBaseline17.18 Breaths per minuteStandard Deviation 6.44
Wait ListChanges in Respiratory RateFollow-up18.73 Breaths per minuteStandard Deviation 4.31
Comparison: This is a calculated P value comparing two groups at baseline and follow-upp-value: 0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026