Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

Study Overview
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Brief Summary
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This study will explore the a Qigong based exercise intervention, here referred to as Meditative Movement (MM), to ameliorate the symptoms associated with chronic obstructive pulmonary disease (COPD) and its co-morbidities. It tests the hypothesis that MM will have a beneficial effect on COPD in FA, particularly on functional ability, respiratory symptoms, affective state, inflammation, and autonomic imbalance. If the hypothesis is correct, MM could be rapidly and inexpensively taught to FA with COPD and other COPD patients to slow degeneration and improve quality of life.

Detailed Description
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The study has three 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 3 is to refine the protocols and methods developed in earlier phases. 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. This is also a RCT.

Official Title
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Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

Conditions
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Pulmonary Disease, Autonomic Dysfunction, COPD

Intervention / Treatment
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* Other: Meditative Movement taught via DVD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Occupation as a flight attendant for at least 5 years No history of significant tobacco use Occupational controls Exclusion Criteria: Inability to give consent History of tobacco habituation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MM Intervention taught via DVD<br>Receive Meditative Movement training via DVD with pre and post interventional testing. | Other: Meditative Movement taught via DVD<br>* Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.<br>* Other names: Qigong;|
| No Intervention: MM Intervention Waitlist Control<br>Testing at same frequency as Meditative Movement interventional subjects. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 minute walk test | Each participant walks as many ft as possible at a brisk pace. The amount of feet covered in 6 minutes is documented. | Baseline, 4 months | 
| Change in C-reactive protein (CRP) | At each assessment circulating CRP will be monitored via blood collected in form of fingerstick. | Baseline, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Systolic and diastolic blood pressure, pre and post 6 minute walk test | Baseline, 4 months | 
| Heart Rate | Heart rate measured pre and post 6 minute walk test | Baseline, 4 months | 
| Oxygen Saturation | O2 saturation measured pre and post 6 minute walk test | Baseline, 4 months | 
| Spirometry: FEV1/FVC | Spirometric measurement of FEV1/FVC administered using EasyOne Spirometer. FEV1/FVC is the ratio of Forced Expiratory Volume (1sec)/FVC (Forced Vital Capacity, (Expiratory)) | Baseline, 4 months | 
| Autonomic Function Self Report | Compass-31 administered via individual self-report. | Baseline, 4 months | 
| Zung Anxiety Scale | Zung anxiety questionnaire administered via individual self report. | Baseline, 4 months | 
| Zung Depression Scale | Zung depression questionnaire administered via individual self report. | Baseline, 4 months | 
| Diurnal Salivary Cortisol | 4 sputum samples collected from subjects | Baseline, 4 months | 
| Melatonin | Melatonin levels from urine samples | Baseline, 4 months | 
| Nicotine Exposure Autonomic Respiratory Syndrome (NEARS) | 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. | Baseline, 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Qigong, ANS, Meditative Movement, Flight Attendants, Secondhand Smoke, Nicotine, Blood Pressure, 6 minute walk test