Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Skeletal muscle mass
研究概览
简要总结
This study evaluates the effects of a whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on skeletal muscle mass, body composition, muscle strength/function, quality of life, fatigue, pain and gastrointestinal symptoms in patients with hematological malignancies 4-6 weeks before and 4-6 weeks after undergoing stem cell Transplantation. Within this context, this study also investigates the effect of the nutrition and exercise intervention on the period of hospitalization, period of White blood cell recovery and frequency and severity of complications (mucositis, Graft-versus-Host-Disease, infections) after stem cell Transplantation as consequences of the therapeutic immune Suppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •adult patients diagnosed with hematological malignancies with an indication for stem cell Transplantation
- •Interval until Transplantation: 6 weeks
- •ECOG Status 0-2
排除标准
- •patients with serious osteolytic lesions and increased risk of fall
- •simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months
- •acute cardiovascular events
- •use of anabolic medications
- •severe neurological diseases
- •skin lesions in the area of electrodes
- •energy active metals in body
- •acute vein thrombosis
- •rheumatic diseases
- •pregnant and nursing women
- •psychiatric disorders with doubts about legal and cognitive capacity
研究组 & 干预措施
Control group
usual care" control group receives individualized nutritional support (dietary advices: daily protein intake 1.2-1.5 g/kg bodyweight),
active exercise therapy is optionally provided (bicycle ergometers at room) during the in-Patient stay
WB-EMS group
physical exercise group regular WB-EMS training (2 EMS trainings per week; each session for 20 min)
- individualized nutritional support (dietary advices: daily protein intake 1.2-1.5 g/kg bodyweight)
active exercise therapy is optionally provided (bicycle ergometers at room) during the in-Patient stay
干预措施: whole-body electromyostimulation (Other)
结局指标
主要结局
Skeletal muscle mass
时间窗: 12 weeks
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
次要结局
- Depression/Anxiety(12 weeks)
- Inflammatory blood markers(12 weeks)
- Physical function - Isometric muscle strength(12 weeks)
- Cardiorespiratory Fitness(12 weeks)
- Patient-reported Quality of Life (QoL)(12 weeks)
- Patient-reported Fatigue(12 weeks)