Clinical trial NCT02612389: Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants
Official title: Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Autonomic Dysfunction
COPD
Keywords: COPD
Qigong
ANS
Meditative Movement
Flight Attendants
Secondhand Smoke
Nicotine
Blood Pressure
6 minute walk test
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Flight Attendant Medical Research Institute
name: ZRT Laboratory
name: Norris Cotton Cancer Center
First posted: 2015-11-23
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 6 minute walk test
timeFrame: Baseline, 4 months
measure: Change in C-reactive protein (CRP)
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: Baseline, 4 months
measure: Heart Rate
timeFrame: Baseline, 4 months
measure: Oxygen Saturation
timeFrame: Baseline, 4 months
measure: Spirometry: FEV1/FVC
timeFrame: Baseline, 4 months
measure: Autonomic Function Self Report
timeFrame: Baseline, 4 months
measure: Zung Anxiety Scale
timeFrame: Baseline, 4 months
measure: Zung Depression Scale
timeFrame: Baseline, 4 months
measure: Diurnal Salivary Cortisol
timeFrame: Baseline, 4 months
measure: Melatonin
timeFrame: Baseline, 4 months
measure: Nicotine Exposure Autonomic Respiratory Syndrome (NEARS)
timeFrame: Baseline, 4 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Geisel School of Medicine, Faculty
name: Steven N Fiering, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Payne P, Fiering S, Zava D, Gould TJ, Brown A, Hage P, Gaudet C, Crane-Godreau M. Digital Delivery of Meditative Movement Training Improved Health of Cigarette-Smoke-Exposed Subjects. Front Public Health. 2018 Oct 19;6:282. doi: 10.3389/fpubh.2018.00282. eCollection 2018.
citation: Payne P, Fiering S, Leiter JC, Zava DT, Crane-Godreau MA. Effectiveness of a Novel Qigong Meditative Movement Practice for Impaired Health in Flight Attendants Exposed to Second-Hand Cigarette Smoke. Front Hum Neurosci. 2017 Feb 21;11:67. doi: 10.3389/fnhum.2017.00067. eCollection 2017.
citation: Payne P, Zava D, Fiering S, Crane-Godreau M. Meditative Movement as a Treatment for Pulmonary Dysfunction in Flight Attendants Exposed to Second-Hand Cigarette Smoke: Study Protocol for a Randomized Trial. Front Psychiatry. 2016 Mar 22;7:38. doi: 10.3389/fpsyt.2016.00038. eCollection 2016.