Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON- Bewegungstherapie in Der Pädiatrischen Stammzelltransplantation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Muscle strength
研究概览
简要总结
The purpose of this randomized controlled two-part study examines the effects of a structured sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in children and adolescents.
The main aspects in the sports groups are resistance, endurance and flexibility training. The control group performs a mental training as well as relaxation exercises.
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
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for hsct
- •Informed consent signed
排除标准
- •Contraindication for exercise
- •Age < 5 years
- •Insuperable language barrier
- •Orthopeadical, cardiological or neurological indication for physical therapy
研究组 & 干预措施
Sport
干预措施: Exercise (Other)
Control
干预措施: Mental Training (Other)
结局指标
主要结局
Muscle strength
时间窗: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Upper limb: hand grip strength with JAMAR dynamometry; Lower limb: maximal isometric voluntary strength of M. quadriceps femoris
次要结局
- Biomarker in blood(daily)
- Endurance performance(change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation)
- Body composition(one time per week and change between 3 months and 6 months after transplantation)
- Fatigue(change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation)
研究者
Peter Bader
Head Department of Stem Cell Transplantation and Immunology
Johann Wolfgang Goethe University Hospital