Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants (MMforFA)

• ClinicalTrials.gov Identifier: NCT02612389
• Recruitment Status: Completed
• First Posted: November 23, 2015
• Last Update Posted: August 18, 2020
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Flight Attendant Medical Research Institute; ZRT Laboratory; Norris Cotton Cancer Center
• Information provided by (Responsible Party): Margaret A. Crane, Dartmouth-Hitchcock Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease; Autonomic Dysfunction; COPD	Other: Meditative Movement taught via DVD	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants
• Study Start Date: March 2015
• Actual Primary Completion Date: June 17, 2020
• Actual Study Completion Date: July 17, 2020

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. Blood Pressure [ Time Frame: Baseline, 4 months ]
   Systolic and diastolic blood pressure, pre and post 6 minute walk test
2. Heart Rate [ Time Frame: Baseline, 4 months ]
   Heart rate measured pre and post 6 minute walk test
3. Oxygen Saturation [ Time Frame: Baseline, 4 months ]
   O2 saturation measured pre and post 6 minute walk test
4. 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))
5. Autonomic Function Self Report [ Time Frame: Baseline, 4 months ]
   Compass-31 administered via individual self-report.
6. Zung Anxiety Scale [ Time Frame: Baseline, 4 months ]
   Zung anxiety questionnaire administered via individual self report.
7. Zung Depression Scale [ Time Frame: Baseline, 4 months ]
   Zung depression questionnaire administered via individual self report.
8. Diurnal Salivary Cortisol [ Time Frame: Baseline, 4 months ]
   4 sputum samples collected from subjects
9. Melatonin [ Time Frame: Baseline, 4 months ]
   Melatonin levels from urine samples
10. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, New Hampshire

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Flight Attendant Medical Research Institute

ZRT Laboratory

Norris Cotton Cancer Center

Investigators

• Principal Investigator: Steven N Fiering, PhD; Geisel School of Medicine, Faculty

More Information

Additional Information:

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 

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 

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 

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

• Responsible Party: Margaret A. Crane, Research Scientist, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT02612389
• Other Study ID Numbers: 28572
• First Posted: November 23, 2015
• Last Update Posted: August 18, 2020
• Last Verified: August 2020

Keywords provided by Margaret A. Crane, Dartmouth-Hitchcock Medical Center:

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

Additional relevant MeSH terms:

Autonomic Nervous System Diseases; Primary Dysautonomias; Nervous System Diseases