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临床试验/NCT03540784
NCT03540784Unknown不适用

Effect of Whole-body Electromyostimulation Combined With a High Protein Diet in Malnourished Patients With Inflammatory Bowel Disease

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
1
主要终点
Skeletal muscle mass

研究概览

简要总结

Patients with inflammatory bowel disease (IBD) often suffer from muscle weakness and a low bone mineral density as a consequence of systemic Inflammation and disease treatment limiting Quality of life in a considerable way. Exercise interventions to build up muscle mass and increasing physical function are promising Tools to improve the whole muscular Status of those patients. However, in the acute Phase of IBDs conventional Training methods may be too strenous, also because patients are suffering from acute gastrointestinal symptoms and feel fatigued. Due to those symptoms, patients present low Food intake and great loss of nutrients and energy especially by diarrhea. Individualized nutritional Support may be helpful to avoid malnutrition. The aim of this pilot study is to investigate the effect of a combined exercise and Nutrition Intervention using the gentle Training method of whole-body electromyostimulation (WB-EMS) combined with a individual high Protein nutritional Support on muscle mass, Body composition, physical function, Quality of life and gastrointestinal symptoms in outpatients with IBD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • •outpatients with inflammatory bowel disease (Crohn's disease, ulcerative Colitis)
  • •adults (18 years and older)

排除标准

  • •simultaneous participation in other nutritional or exercise intervention Trials
  • •acute cardiovascular events
  • •use of anabolic medications
  • •severe neurological diseases
  • •skin lesions in the area of electrodes
  • •energy active metals in body
  • •pregnancy
  • •acute vein thrombosis

研究组 & 干预措施

Control group

No Intervention

usual care treatment

Nutrition

Experimental

high-protein nutrition therapy

干预措施: Nutritional support (Other)

EMS+Nutrition

Experimental

WB-EMS Training (2x/week á 20 min) + high-protein nutrition therapy

干预措施: WB-EMS (Other)

EMS+Nutrition

Experimental

WB-EMS Training (2x/week á 20 min) + high-protein nutrition therapy

干预措施: Nutritional support (Other)

结局指标

主要结局

Skeletal muscle mass

时间窗: 12 weeks

assessed by bioelectrical impedance analysis in kg

次要结局

  • Body composition(12 weeks)
  • Physical activity(12 weeks)
  • Disease activity (ulcerative colitis)(12 weeks)
  • Physical function - lower limb strength(12 weeks)
  • Quality of Life(12 weeks)
  • Physical function - Endurance(12 weeks)
  • Inflammation status(12 weeks)
  • Disease activity (Crohn's disease)(12 weeks)
  • Physical function - isometric muscle strength(12 weeks)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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