Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NCT Number: NCT02612389
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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Interventional
Not applicable
Lebanon, New Hampshire, 03756, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.
Other names: Qigong
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.
Time frame: Baseline, 4 months
At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.
Time frame: Baseline, 4 months
Systolic and diastolic blood pressure, pre and post 6 minute walk test
Time frame: Baseline, 4 months
Heart rate measured pre and post 6 minute walk test
Time frame: Baseline, 4 months
O2 saturation measured pre and post 6 minute walk test
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))
Time frame: Baseline, 4 months
Compass-31 administered via individual self-report.
Time frame: Baseline, 4 months
Zung anxiety questionnaire administered via individual self report.
Time frame: Baseline, 4 months
Zung depression questionnaire administered via individual self report.
Time frame: Baseline, 4 months
4 sputum samples collected from subjects
Time frame: Baseline, 4 months
Melatonin levels from urine samples
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.
Dartmouth-Hitchcock Medical Center
Other
Acronym: MMforFA
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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