Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

COPD Clinical Trial

— MMforFA  

Official title:

Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612389
• Other study ID #: 28572
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 17, 2020

Study information

• Verified date: August 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 17, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• COPD
• Primary Dysautonomias
• Pulmonary Disease

Intervention

Other:
• Meditative Movement taught via DVD
Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (4)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Flight Attendant Medical Research Institute, Norris Cotton Cancer Center, ZRT Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Blood Pressure	Systolic and diastolic blood pressure, pre and post 6 minute walk test	Baseline, 4 months
Secondary	Heart Rate	Heart rate measured pre and post 6 minute walk test	Baseline, 4 months
Secondary	Oxygen Saturation	O2 saturation measured pre and post 6 minute walk test	Baseline, 4 months
Secondary	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
Secondary	Autonomic Function Self Report	Compass-31 administered via individual self-report.	Baseline, 4 months
Secondary	Zung Anxiety Scale	Zung anxiety questionnaire administered via individual self report.	Baseline, 4 months
Secondary	Zung Depression Scale	Zung depression questionnaire administered via individual self report.	Baseline, 4 months
Secondary	Diurnal Salivary Cortisol	4 sputum samples collected from subjects	Baseline, 4 months
Secondary	Melatonin	Melatonin levels from urine samples	Baseline, 4 months
Secondary	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

External Links

•   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.