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临床试验/NCT03157986
NCT03157986已完成不适用

Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease

Schön Klinik Berchtesgadener Land2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Change in Balance Performance during semi Tandem stance

研究概览

简要总结

Aim of this study is to compare the effects of whole-body Vibration Training versus conventional Balance Training on Balance performance, gait quality and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. On top of a standardized endurance and strength Training program (5 days per week) patients in both groups will perform an additional Balance Training (on 3 days per week). Patients in both Groups will perform the same 4 different Balance exercises (2x1 Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg stance but on a different surface. The Vibration Training Group will perform the exercises on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the control Group will perform exercises on instable objects like Balance pads. The degree of difficulty in both Groups will be individually adjusted and will be progressively increased, if possible.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD stage III or IV according to the global initiative for chronic obstructive lung disease
  • impaired exercise capacity (6 Minute walk distance of less than 70% of the reference value from Troosters et al.)

排除标准

  • current acute exacerbation of COPD
  • carbon dioxide pressure of more than 45 mmHg at rest
  • any contraindication for vibration Training (e.g. acute deep vein thrombosis)

结局指标

主要结局

Change in Balance Performance during semi Tandem stance

时间窗: measurement on Day 1 and 21

patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.

次要结局

  • Change in Peak muscle strength of the knee Flexion muscles(measurement on Day 1 and 21)
  • Change in step symmetry during 20m walking(measurement on Day 1 and 21)
  • Change in muscle power during counter movement jump(measurement on Day 1 and 21)
  • Change in performance of the 5-Repetition-Raise-Test(measurement on Day 1 and 21)
  • Change in performance of the 1-Minute-Chair-Rise-Test(measurement on Day 1 and 21)
  • Change in Peak muscle strength of the knee Extension muscles(measurement on Day 1 and 21)
  • Change in 6-minute Walk Distance(measurement on Day 1 and 21)
  • Change in 4m Gait Speed Test(measurement on Day 1 and 21)
  • Change in Hospital anxiety and Depression scale(measurement on Day 1 and 21)
  • Change in balance performance during Romberg stance(measurement on Day 1 and 21)
  • Change in Balance Performance during 1-leg stance(measurement on Day 1 and 21)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Klaus Kenn

Head physican (department of pneumology)

Schön Klinik Berchtesgadener Land

研究点 (2)

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