Exploring the Dose-Response Effect of Adjunctive Acupuncture on Pulmonary Rehabilitation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Incidence of Acute Exacerbations (AE)
研究概览
简要总结
The investigator is investigating if acupuncture may improve pulmonary function, exercise tolerance, stress and modulate the inflammatory effects of chronic obstructive pulmonary disease (COPD). The investigator would like to measure the effect of the combination of acupuncture with standard pulmonary rehab in patients with COPD.
详细描述
Participation in this study may last 3 months. The experimental intervention is electro-acupuncture. Electro-acupuncture is similar to Transcutaneous Electrical Nerve Stimulation (TENS) where a very small current of electricity is applied, in this case to specific acupuncture points. The intervention will be applied by a trained physician-acupuncturist. The treatment itself would be applied for 20 minutes prior to regularly scheduled pulmonary rehab session. All participants will receive electro-acupuncture for the duration of the study. Because the investigators are interested in the effect of dose, participants will be randomized to 4, 8 or 12 weeks of "active pulmonary" acupuncture versus "control" acupuncture. One third of the participants will be asked to undergo the intervention for 4 weeks, one third will be asked to undergo the intervention for 8 weeks and one third will be asked to undergo the intervention for 12 weeks. Intervention acupuncture needles will be placed on what are thought to be active points for helping lung function, control acupuncture needles will be placed in neutral locations. Participants will not be told which weeks they are receiving the active acupuncture versus the control. Information relating to pulmonary and physical function, standard blood markers of inflammation, and survey responses at the beginning, during and after the intervention will be collected. During the experimental period participants will be asked to fill out surveys on quality of life, pulmonary function and physical function.
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
- Single (Participant)
盲法说明
Participants will not be told which weeks they are receiving the active acupuncture versus the control.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years of age or older
- •Qualify to participate in the pulmonary rehab program at DHMC
排除标准
- •Severe cognitive impairment
- •Active pulmonary exacerbation
- •Unstable cardiopulmonary disease
结局指标
主要结局
Incidence of Acute Exacerbations (AE)
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Throughout the course of the study acute exacerbations will be recorded and tallied.
Change in Forced Expiratory Volume in One Second (FEV1)
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test
Change in Forced Vital Capacity (FVC)
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Forced vital capacity (FVC) as measures by spirometry test
Change in Number of Eosinophils
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in number of eosinophils as measured in blood samples
Change in Number of Neutrophil
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in number of neutrophil as measured in blood samples
Change in Number of C Reactive Protein
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in number of C reactive protein as measured in blood samples
Quality of Life Relating to Dyspnea as Measured by Borg Scales
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
The Borg Dyspnea Scale scores range from 0 to 10, measuring subjective respiratory exertion with higher scores being worse
Change in Health Related Quality of Life as Measured by the St. George's Respiratory Questionnaire
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
The St. George's Respiratory Questionnaire scores range from 0 to 100, with higher scores indicating more limitations. The 50-item questionnaire was developed to measure health status (quality of life) in patients with diseases of airways obstruction.
Change in Health Related Quality of Life as Measure by the Patient Health Questionnaire (PHQ-9)
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
The Patient Health Questionnaire-9 scale questionnaire measures the level of depression. Score range is 0 to 27 points. Higher scores mean more severe depression.
Change in 6-minute Walk Distance
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in maximum distance walked in 6 minutes
Incidence of Acute Exacerbations (AE)
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Throughout the course of the study acute exacerbations will be recorded and tallied.
次要结局
未报告次要终点
研究者
James E. Stahl
Principal Investigator; Staff Physician, General Internal Medicine
Dartmouth-Hitchcock Medical Center