An interventional study of Meditative Movement taught via DVD in Pulmonary Disease, Autonomic Dysfunction and COPD, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-08-18.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment
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.
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.
166 studies on the registry are indexed under Autonomic Nervous System Diseases; 36 are open to participants now.
This study's enrollment of 220 is above the median of 40 across 107 interventional studies indexed under Autonomic Nervous System Diseases.
Browse Autonomic Nervous System Diseases studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receive Meditative Movement training via DVD with pre and post interventional testing.
Other: Meditative Movement taught via DVD
Testing at same frequency as Meditative Movement interventional subjects.
Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.
Also known as: Qigong
Change in 6 minute walk test
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
Change in C-reactive protein (CRP)
At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.
Time frame: Baseline, 4 months
Blood Pressure
Systolic and diastolic blood pressure, pre and post 6 minute walk test
Time frame: Baseline, 4 months
Heart Rate
Heart rate measured pre and post 6 minute walk test
Time frame: Baseline, 4 months
Oxygen Saturation
O2 saturation measured pre and post 6 minute walk test
Time frame: Baseline, 4 months
Spirometry: FEV1/FVC
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
Autonomic Function Self Report
Compass-31 administered via individual self-report.
Time frame: Baseline, 4 months
Zung Anxiety Scale
Zung anxiety questionnaire administered via individual self report.
Time frame: Baseline, 4 months
Zung Depression Scale
Zung depression questionnaire administered via individual self report.
Time frame: Baseline, 4 months
Diurnal Salivary Cortisol
4 sputum samples collected from subjects
Time frame: Baseline, 4 months
Melatonin
Melatonin levels from urine samples
Time frame: Baseline, 4 months
Nicotine Exposure Autonomic Respiratory Syndrome (NEARS)
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.
Time frame: Baseline, 4 months
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center