ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02612389
Recruitment Status : Recruiting
First Posted : November 23, 2015
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
Flight Attendant Medical Research Institute
ZRT Laboratory
Norris Cotton Cancer Center
Information provided by (Responsible Party):
Margaret A. Crane, Dartmouth-Hitchcock Medical Center

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 two 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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 2020

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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Exclusion Criteria:

  • Inability to give consent
  • History of tobacco habituation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612389


Contacts
Contact: Mardi A Crane, PhD 603-653-9972 margaret.a.crane@dartmouth.edu
Contact: Carole Gaudet 603-653-9972 carole.gaudet@dartmouth.edu

Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Mardi A Crane, PhD    603-653-9972    margaret.a.crane@dartmouth.edu   
Contact: Peter Peter    603-653-9972    peter.payne@dartmouth.edu   
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Margaret A. Crane, Research Scientist, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02612389     History of Changes
Other Study ID Numbers: 28572
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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:
Lung Diseases
Autonomic Nervous System Diseases
Primary Dysautonomias
Respiratory Tract Diseases
Nervous System Diseases