NCT02293239已完成不适用
Effects of Whole-Body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Support on Patients With Malignant Disease Undergoing Curative or Palliative Anti-cancer Treatment
University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Physical function - Gait pattern
研究概览
简要总结
This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
- •ongoing or planned curative or palliative anti-cancer therapy
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
结局指标
主要结局
Physical function - Gait pattern
时间窗: 12 weeks
Sensor-based gait analysis
Skeletal muscle mass
时间窗: 12 weeks
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
次要结局
- Patient-reported performance status(12 weeks)
- Patient-reported Fatigue(12 weeks)
- Patient-reported Quality of Life (QoL)(12 weeks)
- Physical function - Endurance(12 weeks)
- Physical function - Isometric muscle strength(12 weeks)
- Physical function - Lower limb strength(12 weeks)
- Inflammatory blood markers(12 weeks)
研究者
研究点 (2)
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