Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

NCT ID: NCT02612389

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-07-17

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.

Conditions

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Pulmonary Disease Autonomic Dysfunction COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MM Intervention taught via DVD

Receive Meditative Movement training via DVD with pre and post interventional testing.

Group Type EXPERIMENTAL

Meditative Movement taught via DVD

Intervention Type OTHER

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

MM Intervention Waitlist Control

Testing at same frequency as Meditative Movement interventional subjects.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Meditative Movement taught via DVD

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

Intervention Type OTHER

Other Intervention Names

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Qigong

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Flight Attendant Medical Research Institute

OTHER

Sponsor Role collaborator

ZRT Laboratory

OTHER

Sponsor Role collaborator

Norris Cotton Cancer Center

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Margaret A. Crane

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven N Fiering, PhD

Role: PRINCIPAL_INVESTIGATOR

Geisel School of Medicine, Faculty

Locations

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Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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Zhang L, Xu Y. Impact of Radiation Therapy on Outcomes of Artificial Urinary Sphincter: A Systematic Review and Meta-Analysis. Front Surg. 2022 Feb 14;9:825239. doi: 10.3389/fsurg.2022.825239. eCollection 2022.

Reference Type DERIVED
PMID: 35237650 (View on PubMed)

Ye X, Gu Y, Bai Y, Xia S, Zhang Y, Lou Y, Zhu Y, Dai Y, Tsoi JK, Wang S. Does Low-Magnitude High-Frequency Vibration (LMHFV) Worth for Clinical Trial on Dental Implant? A Systematic Review and Meta-Analysis on Animal Studies. Front Bioeng Biotechnol. 2021 Apr 27;9:626892. doi: 10.3389/fbioe.2021.626892. eCollection 2021.

Reference Type DERIVED
PMID: 33987172 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30406067 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28270757 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27047398 (View on PubMed)

Related Links

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https://www.frontiersin.org/articles/10.3389/fpsyt.2016.00038/full

Payne P, et al. (2016) 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 7:38. doi: 10.3389/fps

https://www.frontiersin.org/articles/10.3389/fnhum.2017.00067/full

Payne P, et al. (2017) Effectiveness of a Novel Qigong Meditative Movement Practice for Impaired Health in Flight Attendants Exposed to Second-Hand Cigarette Smoke. Front. Hum. Neurosci. 11:67. doi: 10.3389/fnhu

https://www.frontiersin.org/articles/10.3389/fpubh.2018.00282/full

Payne P, Fiering S, Zava D, Gould TJ, Brown A, Hage P, Gaudet C and Crane-Godreau M (2018) Digital Delivery of Meditative Movement Training Improved Health of Cigarette-Smoke-Exposed Subjects. Front. Public Health 6:282. doi: 10.3389/fpubh.2018.00282

http://www.bodymindscience.info

Website for Body Mind Science. Investigators are no longer at Dartmouth. Future publication links will be at the BodyMind Science sites.

Other Identifiers

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28572

Identifier Type: -

Identifier Source: org_study_id

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