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Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02612389
Acronym
MMforFA
Enrollment
220
Registered
2015-11-23
Start date
2015-03-31
Completion date
2020-07-17
Last updated
2020-08-18

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

Conditions

Autonomic Dysfunction, COPD, Pulmonary Disease

Keywords

COPD, Qigong, ANS, Meditative Movement, Flight Attendants, Secondhand Smoke, Nicotine, Blood Pressure, 6 minute walk test

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.

Interventions

OTHERMeditative Movement taught via DVD

Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.

Sponsors

Flight Attendant Medical Research Institute
CollaboratorOTHER
ZRT Laboratory
CollaboratorOTHER
Norris Cotton Cancer Center
CollaboratorOTHER
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in 6 minute walk testBaseline, 4 monthsEach 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)Baseline, 4 monthsAt each assessment circulating CRP will be monitored via blood collected in form of fingerstick.

Secondary

MeasureTime frameDescription
Oxygen SaturationBaseline, 4 monthsO2 saturation measured pre and post 6 minute walk test
Spirometry: FEV1/FVCBaseline, 4 monthsSpirometric 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 ReportBaseline, 4 monthsCompass-31 administered via individual self-report.
Zung Anxiety ScaleBaseline, 4 monthsZung anxiety questionnaire administered via individual self report.
Blood PressureBaseline, 4 monthsSystolic and diastolic blood pressure, pre and post 6 minute walk test
Diurnal Salivary CortisolBaseline, 4 months4 sputum samples collected from subjects
MelatoninBaseline, 4 monthsMelatonin levels from urine samples
Nicotine Exposure Autonomic Respiratory Syndrome (NEARS)Baseline, 4 monthsNew 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.
Zung Depression ScaleBaseline, 4 monthsZung depression questionnaire administered via individual self report.
Heart RateBaseline, 4 monthsHeart rate measured pre and post 6 minute walk test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026