Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Change in 6 minute walk test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Occupation as a flight attendant for at least 5 years
- •No history of significant tobacco use
- •Occupational controls
排除标准
- •Inability to give consent
- •History of tobacco habituation
结局指标
主要结局
Change in 6 minute walk test
时间窗: 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.
Change in C-reactive protein (CRP)
时间窗: Baseline, 4 months
At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.
次要结局
- Blood Pressure(Baseline, 4 months)
- Heart Rate(Baseline, 4 months)
- Oxygen Saturation(Baseline, 4 months)
- Spirometry: FEV1/FVC(Baseline, 4 months)
- Autonomic Function Self Report(Baseline, 4 months)
- Zung Anxiety Scale(Baseline, 4 months)
- Zung Depression Scale(Baseline, 4 months)
- Diurnal Salivary Cortisol(Baseline, 4 months)
- Melatonin(Baseline, 4 months)
- Nicotine Exposure Autonomic Respiratory Syndrome (NEARS)(Baseline, 4 months)
研究者
Margaret A. Crane
Research Scientist
Dartmouth-Hitchcock Medical Center