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

August 14, 2020 updated by: Margaret A. Crane, Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Qigong
NO_INTERVENTION: MM Intervention Waitlist Control
Testing at same frequency as Meditative Movement interventional subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 months
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.
Baseline, 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Norris Cotton Cancer Center
ZRT Laboratory
Flight Attendant Medical Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

June 17, 2020

Study Completion (ACTUAL)

July 17, 2020

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (ESTIMATE)

November 23, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28572

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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