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

Dartmouth Health

Status: Completed

Conditions: Pulmonary Disease; COPD; Autonomic Dysfunction

Treatments: Other: Meditative Movement taught via DVD

Study type: Interventional

Funder types: Other

Identifiers

NCT02612389

28572

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

MM Intervention taught via DVD

Experimental group

Description:

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

Treatment:

Other: Meditative Movement taught via DVD

MM Intervention Waitlist Control

No Intervention group

Description:

Testing at same frequency as Meditative Movement interventional subjects.