Evaluation of the Effects of Whole Body Vibration Training With the Galileo Training Device on the Lung Function of Patients With Stable COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- FEV1
研究概览
简要总结
The typical clinical progression of COPD usually results in a decreased level of tolerable physical exertion for the patient. The avoidance of strenuous physical activity leads to a deteriorating level of physical fitness, which further decreases the patient's ability to undertake physical activities. Recent research has shown that whole body vibration has the potential to improve physical fitness of participants, including such measures as the 6 minute walking distance. However, information concerning lung function is lacking.
The goal of the study is to test whether the use of whole body vibration training has an effect on the lung function of patients with stable COPD, or if the previously observed effects can be attributed to either pharmaceutical therapy or physical therapy interventions.
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)
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
- •Stable COPD (Gold II-IV)
- •Signed understanding of participation
- •The patients must be able to understand and follow the requirements of participation (Understanding of the German language)
排除标准
- •Acute thrombosis
- •Hemoptysis
- •Implants in the targeted training regions (joint implants)
- •Acute joint inflammation, active arthrosis or arthropathy.
- •Rheumatoid arthritis
- •Acute tendinopathy in the targeted training regions
- •Acute hernia
- •Acute discopathy
- •Fresh fracture in the targeted training regions
- •Gall or kidney stones
- •Wounds still in the process of healing
- •Severe neurologic disorders (apoplexy, paralysis of upper and lower extremities)
- •Severe circulatory disorders (Cardiac insufficiency NYHA > or = III, myocardial infarct less than one month prior, circulatory relevant rhythm disorders, idiopathic syncope)
- •Tension pneumothorax
- •Acute internal bleeding
- •Current therapy with fluoroquinolone
- •Alcohol/drug/medication abuse
研究组 & 干预措施
Control
Whole body vibration training as sham procedure (5Hz) 3 times a week, 3x2 minutes, for 6 weeks.
干预措施: Whole Body Vibration (Device)
Intervention
Whole body vibration training (12 Hz up to 30 Hz) 3 times a week, 3x2 minutes, for 6 weeks.
干预措施: Whole Body Vibration (Device)
结局指标
主要结局
FEV1
时间窗: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
次要结局
- PHQ-9 (Brief Patient Health Questionnaire(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- SGRQ-C: Saint George´s Respiratory Questionnaire for COPD Patients(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- Maximal inspiratory pressure(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- Handheld Dynamometry Strength Testing of Extremities(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- Diffusion capacity for oxygen(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- SF-12: Short Form (12) Health Questionnaire(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- CAT: COPD Assessment Test(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- mMRC: Modified British Medical Research Council(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- 6 Minute Walking Test(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
- Chair Rising Test(Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2))
研究者
Felix JF Herth
Medical Director
Heidelberg University