Effects of a Specific Strength Training Regarding Activities of Daily Living (ADLs) Associated With Movement During Treatment of Leukemia or Non-Hodgkin Lymphoma in Childhood and Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of score of the Activities Scale for Kids - performance version
研究概览
简要总结
Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. Primary outcome of this RCT (n=20/20) is the analysis of effects of a treatment-associated and close to every day life strength training (2-3 times/week) compared to a general exercise program (standard care).
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
- •Diagnosed with Acute Leukemia or Non-Hodgkin Lymphoma
- •Diagnosed and/or treated at the Kinderklinik München Schwabing, Technische Universität München
- •Informed consent as documented by signature
排除标准
- •Medical contraindications regarding strength training (e.g. risk of bleeding, ...)
- •Contraindications to one of the inclusion criteria mentioned above
- •Inability to follow the procedures and understand the intervention and assessments of this study, e.g. due to cognitive impairment, language problems, psychological disorders etc.
结局指标
主要结局
Change of score of the Activities Scale for Kids - performance version
时间窗: Change of the ASK score from baseline to 3 months, change from 3 months to 6 months, change from 6 months to 12 months
The ASK - Activities Scale for Kids performance version by NL Young assesses an overall summary score (0-100) of self-reported activities of daily living in children and adolescents. The scale monitors changes associated with therapeutic interventions. Higher values represent a better outcome. The ASK contains 30 items in 7 sub-domains (personal care, dressing, other skills, locomotion, play, standing skills and transfer).
次要结局
- Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON)(Change of motor performance from baseline to 6 months)
- Change of level of physical activity(Change of physical activity level from baseline to 3 months, from 3 to 6 months, from 6 to 12 months)
- Change in performance in a parkour in activities of daily living(Change of score in the parkour from baseline to 6 months)
研究者
Sabine Kesting
Prinzipal Investigator
Technical University of Munich