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Completed

NCT Number: NCT02612389

Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditative Movement taught via DVD

Other

Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.

Other names: Qigong

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Flight Attendant Medical Research Institute
  • Norris Cotton Cancer Center
  • ZRT Laboratory

Registry information

Acronym: MMforFA

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 23, 2015
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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