跳至主要内容
临床试验/NCT01944761
NCT01944761已完成不适用

The Neuro-protective Effects of Exercise in Children Treated With Cranial Radiation for Brain Tumors

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Feasibility of implementing an excercise intervention

研究概览

简要总结

The objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved outcome, particularly recovery of white matter and grey matter.

详细描述

Brain tumors are the leading cause of death and disability from childhood disease in developed countries. With treatment advances over the last 25 years, survival rates have improved dramatically. However, survival is often achieved at considerable cost. Cranial radiation is frequently required for effective tumor control, and is associated with significant neuro-toxicity, including white matter damage and cognitive morbidity. In order to achieve the best possible outcome for survivors, and ultimately conquer the long-term consequences of this disease, new interventions must be developed to ameliorate the neuro-toxic effects experienced by children. radiation injury can now be used to guide the development of interventions designed to rescue neural tissue. Furthermore, various new agents and activities with potential to stimulate neuro-recovery are now available. The potential value of exercise for rescuing the brain from neuro-toxic effects, for instance, has recently been reported. Next, neuro-cognitive processes that are particularly sensitive to the effects of cranial radiation have been identified and can serve as behavioral assays to test the effectiveness of these new interventions. Finally, novel neuro-imaging tools are available to perform in vivo evaluations in order to delineate potential mechanisms of neuro-recovery. We intend to integrate these new research findings to develop and evaluate a physical exercise-based intervention targeted at rescuing brain tissue of children with brain tumors from the neuro-toxic impact of cranial radiation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Survivors will be included if they are between 7 and 17 years of age.
  • Survivors will be included if they either declare English as their native language or have had at least two years of schooling in English at the time of their first assessment.
  • Survivors must have been diagnosed with a hemispheric or posterior fossa tumor and been treated with cranial spinal radiation.
  • Survivors no more than 10 years may have elapsed between diagnosis and time of study.
  • Survivors with a shunt will be included in the study, but will need to be identified prior to study on-set to discuss any specific considerations for imaging and physical activity.

排除标准

  • are younger than 7 years (the delivery of an intervention program to young children carries challenges that make it difficult to include in an initial feasibility grant) or older than 17 years
  • require sedation for MRI imaging
  • is claustrophobic
  • have severe neurological/motor dysfunction that would preclude safe participation in an exercise program.

结局指标

主要结局

Feasibility of implementing an excercise intervention

时间窗: At week 42-45

We will look at several factors, including recruitment rate, exercise adherence rate, retention rate and participant/parent satisfaction to determine the feasability of this intervention

次要结局

  • Neuro-cognitive outcome(Baseline, once at week 26-29 and once at week 42-45)
  • Neural recovery (gliogenesis/neurogenesis)(Baseline, once at week 26-29 and once at week 42-45)
  • Fitness(Baseline, once at week 26-29 and once at week 42-45)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donald Mabbott

Psychologist

The Hospital for Sick Children

研究点 (2)

Loading locations...

相似试验