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临床试验/NCT02216604
NCT02216604已完成不适用

Physical Activity Intervention Program for Childhood Cancer Patients Under Chemo- and/or Radiation Therapy

German Cancer Research Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Feasibility after 6 month

研究概览

简要总结

Today about 80% childhood cancer patients become long-time survivors. In spite of the high cure rates the diagnosis cancer is associated with a variety of disease and treatment-related psychological and physical impairments mostly present into adulthood. So the attention has to focus on the improvement of these problems such as motor limitation, dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished quality of life (Qol). Although exercisel intervention studies in this field are generally scarce, the results of these studies are promising. Up to now studies during the acute phase of treatment are missing almost completely. The aim of this feasibility study is to evaluate the potential benefits of a modular exercise intervention program for childhood cancer patients startunf in parallel with treatment and longlasting for one year. Across two years cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21 years, free of any contraindications for physical activity will be recruited. All participants are asked to complete a physical assessment battery (strength, endurance and balance capacity, posture control, functional mobility, range of motion) and additionally two questionnaires concerning Qol and motivation, at baseline and every three months following one year

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
5 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
  • date of diagnosis not longer than 8 weeks ago

排除标准

  • severe cardiac impairment
  • bone metastasis inducing skeletal fragility
  • other orthopedic diseases or any other circumstance that would impede ability to give informed consent or adherence to study requirements.

研究组 & 干预措施

Intervention group

Experimental

Multimodal Exercise intervention (console-based training, age-specific resistance training and body awareness)

干预措施: Multimodal Exercise Intervention (Behavioral)

Control

No Intervention

age, disease and gender matched

结局指标

主要结局

Feasibility after 6 month

时间窗: after primary treatment (6 month)

Will be measured as the proportion of patients following the exercise prescription.

次要结局

  • Quality of Life(after primary treatment (6 month) and after one year)
  • Feasibility between 6 and 12 month(between end of primary treatment (6 month) and one year)
  • Physical performance(after primary treatment (6 month) and after one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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