Effect of Whole-body Electromyostimulation Combined With a High Protein Diet in Malnourished Patients With Inflammatory Bowel Disease
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
usual care treatment
Nutrition
high-protein nutrition therapy
干预措施: Nutritional support (Other)
EMS+Nutrition
WB-EMS Training (2x/week á 20 min) + high-protein nutrition therapy
干预措施: WB-EMS (Other)
EMS+Nutrition
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)
