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临床试验/NCT02144129
NCT02144129撤回不适用

Effects of Different Types of Whole Body Electromyostimulation (WB-EMS) Application on Body Composition, Muscle Strength and Quality of Life in Patients With Ulcerative Colitis

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Lean Body Mass

研究概览

简要总结

The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated passive in a supine resting position or active during slight movements compared with a non-training control group on body composition, muscle strength and QoL in patients with ulcerative colitis.

Our main hypothesis is that active WB-EMS application is significantly more favorable to address our primary endpoints compared with passive application.

Our secondary hypothesis is that passive WB-EMS application is significantly more favorable to address our primary endpoints compared with non-training control.

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 (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •ulcerative colitis
  • •ambulatory subjects

排除标准

  • •variables that conflicts with WB-EMS application (e.g. cardiac pacemakers)
  • •absence of more than two weeks during the interventional period.

研究组 & 干预措施

active WB-EMS

Experimental

2 sessions/week with 20 min of active WB-EMS application

干预措施: active Whole Body Electromyostimulation (Other)

active WB-EMS

Experimental

2 sessions/week with 20 min of active WB-EMS application

干预措施: WB-EMS application (Device)

Passive WB-EMS

Experimental

2 sessions/week with 20 min of passive WB-EMS application in a resting supine position

干预措施: Passive WB-EMS (Other)

Inactive Control Group

No Intervention

sedentary non-training control group

结局指标

主要结局

Lean Body Mass

时间窗: 12 weeks, baseline to 12 week follow-up

Lean Body Mass (LBM) and Appendicular Skeletal Muscle Mass (ASMM) as assessed by Dual-Energy-x-Ray Absorptiometry (DXA)

Isokinetic muscle strength

时间窗: 12 weeks, baseline to 12 week follow-up

Isokinetic muscle strength of the leg extensors and - flexors as assessed by a isokinetic leg strength

次要结局

  • Quality of Life (QoL)(12 weeks, baseline to 12 week follow-up)
  • Isometric muscle strength(12 weeks, baseline 12 week follow-up)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolfgang Kemmler

Professor Dr.

University of Erlangen-Nürnberg Medical School

研究点 (1)

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Effects of WB-EMS in Ulcerative Colitis Patients | 临床试验