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临床试验/NCT01645436
NCT01645436已完成不适用

Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial

Universidad Europea de Madrid2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
2
主要终点
Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests

研究概览

简要总结

The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer (PAPEC) is to assess the impact of an exercise program intervention in pediatric cancer patients undergoing chemotherapy for solid tumors. The investigators hypothesized the intervention will have a beneficial effect on the study outcomes.

详细描述

Sixty patients, of both sexes, children will be recruited for this trial with an age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors). Each participant will be assigned randomly (with blocking on sex) to either intervention or control (usual care) group.

The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.

Primary outcomes [cardio-respiratory capacity (peak oxygen uptake), muscle strength (6RM leg and bench press, and lateral row), functional capacity ('Timed Up and Down Stairs test', and '3 m and 10m Time Up and Go tests'), physical activity levels (determined by accelerometry) and quality of life "Child Report Form of the Child's Health and Illness Profile-Child Edition", Adolescent Edition and Parents Report Form )] and secondary outcomes [immune function (immune cell subpopulations, natural killer cells' cytotoxicity), inflammatory profile (blood levels of 47 cytokines) and leukocyte telomere length] will be measured in both groups in the following time points:

(i) before the exercise intervention (immediately after diagnosis and before the start of treatment); (ii) after the exercise intervention (upon termination of neoadjuvant chemotherapy); and iii) after a detraining period (2 months after the intervention).

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
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors) treated in the Hospital Infantul Niño jesús and residents in Madrid community. -

排除标准

  • age<4 years or >16 years, other tumours

结局指标

主要结局

Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests

时间窗: up to 3 years

次要结局

  • inflammatory profile(up to 3 years)

研究者

发起方
Universidad Europea de Madrid
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Lucia

MD PhD, PROFESSOR IN EXERCISE PHYSIOLOGY

Universidad Europea de Madrid

研究点 (2)

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Physical Activity in Pediatric Cancer (PAPEC) | 临床试验