NCT02612025已完成不适用
Effects of Combined Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase
Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Muscle strength: lower limb
研究概览
简要总结
The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase.
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant Tumor
- •Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany)
- •> 3 years
- •Signed Informed Consent
排除标准
- •Functional and/or cognitive limitations which limit performance during training
- •Orthopedic condition which hinders to adequately participate in exercise training
- •Heart failure (NYHA III-IV)
- •Partial or global respiratory failure
- •Symptomatic coronary disease
- •Serious therapy-refractory hypertonia
- •Sustainable thrombocytopenia <10.000/µl, f. ex. therapy-refractory autoimmune thrombocytopenia
- •Hereditary or acquired thrombocytopenia or coagulation disturbance
- •Uncontrolled cerebral spasm
- •CNS metastases
- •Medical or psychological condition which does in the doctors opinion not allow participation in sport activity
研究组 & 干预措施
Exercise group
Experimental
Exercise training during intensive medical treatment
干预措施: Exercise Training (Behavioral)
Control group
No Intervention
Usual Care
结局指标
主要结局
Muscle strength: lower limb
时间窗: Six weeks (pre-post intervention)
Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test
次要结局
- Six-minute-walk performance(Six weeks (pre-post intervention))
- Muscle strength: upper limb(Six weeks (pre-post intervention))
- Body composition(Six weeks (pre-post intervention))
- Fatigue(six weeks (pre-post intervention))
- Biomarker in Blood(At the beginning of the intervention and three and six weeks after the beginning. Comparing the two time points inbetween study groups)
- Quality of Life(Six weeks (pre-post intervention))
- Cardiorespiratory performance(Six weeks (pre-post intervention))
研究者
Univ.Prof.Dr.med. Joerg Faber
Univ.-Prof. Dr. med.
Johannes Gutenberg University Mainz
研究点 (2)
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