Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants (MMforFA)
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|ClinicalTrials.gov Identifier: NCT02612389|
Recruitment Status : Recruiting
First Posted : November 23, 2015
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease Autonomic Dysfunction COPD||Other: Meditative Movement taught via DVD||Not Applicable|
The study has two phases.
Phase 1 will identify the best MM practices and their impact on a test group of affected FA. Phase 2 will develop a video to apply what is learned in Phase 1 to a larger group of affected FA, and will document the resulting impact on various aspects of pulmonary dysfunction and its comorbidities.
Phase 1: To identify the best set of MM exercises for improving COPD-related symptoms. This will be done by conducting a 12-week in-person MM program that will be held in one or more locations in the Northeastern region of the US and possibly other regions of the country.These training sessions will be used to determine precisely which MM exercises are most appropriate for this group. Selection will be based on professional judgment, participant feedback, and objective pre- and post-intervention measurements taken at the beginning and end of the 12-week program.
Phase 2: To use an RCT to evaluate the effectiveness of the exercises selected in Aim 1, as delivered by video only. We will design and produce an instructional DVD based on the findings in Aim 1.In the RCT we will test the hypothesis that targeted MM training and practice using the DVD alone will improve QOL, exercise tolerance, autonomic balance and pulmonary function, and reduce fatigue, in flight attendants with a COPD diagnosis. Pre- and post-intervention measurements will be compared, and to outcomes from a control group of flight attendants who will be wait listed for later participation in the study.
Phase 3: The videos used to train subjects in Phase II will be refined and the order of introduction of training modules will be adjusted. Efficacy will again be tested in newly recruited subjects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||May 30, 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: MM Intervention taught via DVD
Receive Meditative Movement training via DVD with pre and post interventional testing.
Other: Meditative Movement taught via DVD
Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.
Other Name: Qigong
No Intervention: MM Intervention Waitlist Control
Testing at same frequency as Meditative Movement interventional subjects.
- Change in 6 minute walk test [ Time Frame: Baseline, 4 months ]Each participant walks as many ft as possible at a brisk pace. The amount of feet covered in 6 minutes is documented.
- Change in C-reactive protein (CRP) [ Time Frame: Baseline, 4 months ]At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.
- Blood Pressure [ Time Frame: Baseline, 4 months ]Systolic and diastolic blood pressure, pre and post 6 minute walk test
- Heart Rate [ Time Frame: Baseline, 4 months ]Heart rate measured pre and post 6 minute walk test
- Oxygen Saturation [ Time Frame: Baseline, 4 months ]O2 saturation measured pre and post 6 minute walk test
- Spirometry: FEV1/FVC [ Time Frame: Baseline, 4 months ]Spirometric measurement of FEV1/FVC administered using EasyOne Spirometer. FEV1/FVC is the ratio of Forced Expiratory Volume (1sec)/FVC (Forced Vital Capacity, (Expiratory))
- Autonomic Function Self Report [ Time Frame: Baseline, 4 months ]Compass-31 administered via individual self-report.
- Zung Anxiety Scale [ Time Frame: Baseline, 4 months ]Zung anxiety questionnaire administered via individual self report.
- Zung Depression Scale [ Time Frame: Baseline, 4 months ]Zung depression questionnaire administered via individual self report.
- Diurnal Salivary Cortisol [ Time Frame: Baseline, 4 months ]4 sputum samples collected from subjects
- Melatonin [ Time Frame: Baseline, 4 months ]Melatonin levels from urine samples
- Nicotine Exposure Autonomic Respiratory Syndrome (NEARS) [ Time Frame: Baseline, 4 months ]New questionnaire under evaluation to reflect autonomic influences on respiratory and other physiologic functions in nicotine exposed study population. Range and meaning of range are yet to be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612389
|Contact: Mardi A Crane, PhDemail@example.com|
|Contact: Peter Paynefirstname.lastname@example.org|
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756|
|Contact: Mardi A Crane, PhD 603-653-9972 email@example.com|
|Contact: Peter Payne 603-653-9972 firstname.lastname@example.org|
|Principal Investigator:||Steven N Fiering, PhD||Geisel School of Medicine, Faculty|