Influence of Training With Whole Body Vibration Device (Galileo) on Quality of Life (QoL), Exercise Capacity, as Well as on the Effects of Muscle Power and Muscle Function in Patients With Pulmonal Arterial Hypertension (PAH). (GALILEO PAH)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- changes in 6-Minute Walk Distance (6MWD)
研究概览
简要总结
Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.
详细描述
Study Design: Open Monocentric prospective randomized observational trial Study arms: Treatment group (4-weeks wbv training) planned 20 patients Control group: planned 20 patients Endpoint (-s): Changes in muscle power, changes in 6-Minute Walk Distance (6MWD), changes in QoL changes in peak VO2 (bike exercise test)
Major study procedures:
Blood samples, vital parameters, questionnaires, echocardiography, lung function test, blood gas analysis, bike exercise test, 6-Minute Walk test, ECG, Chair rising test, power plate measurement, walk across test
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
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 18-90 years
- •Signed informed consent
- •Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)
- •Invasively confirmed PAH
- •6MWT ≥ 50 m
- •Stable specific therapy for at least 2 months
- •Ability to perform bike test
- •Ability to perform wbv training
- •NYHA/WHO-FC II-III
排除标准
- •any other PAH/PH than idiopathic, hereditary or associated with systemic scleroderma
- •Rehabilitation or other training concept performed within 2 months before inclusion
- •pregnancy
- •acute thrombosis
- •newly implanted Hip or Knee
- •recent bone fracture
- •Disability to confirm consent
- •NYHA/WHO-FC IV
结局指标
主要结局
changes in 6-Minute Walk Distance (6MWD)
时间窗: baseline and week 4
次要结局
- Changes in muscle power(baseline and week 4)
- Changes in peak Vo2(baseline and week 4)
- Changes in Quality of life(baseline and week 4)
研究者
Felix Gerhardt
PhD
Klinikum der Universität Köln