Physical Activity Program in Children and Adolescents With Cancer : Assessment of Benefits on Physical, Psychological and Social Health.

Study Overview
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Brief Summary
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Context: Sport and physical activity during and after cancer treatment can improve fitness and social inclusion in adults. In children, although early studies show interesting results, conclusive data are lacking. A preliminary evaluation conducted in a dozen children following a physical training program showed a significant improvement in endurance, muscle tone, overall self-esteem, sports skills and self-perceived strength. The investigators then want to evaluate the health of a group of children during treat cancer that physical activities adapted compared to children who did not practice. Objective: Measuring the impact of physical activity program on health of children and adolescents with cancer with improved physical, psychological health, social reintegration and reduced time hospitalization. Method and Design: The study plans to include 90 children from the pediatric hematology - oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18 months. This is a randomized controlled open trial open with a stratified distribution. Children will be randomized between two arms - Arm A (Experimental - Immediate Program): the child follows the physical activity program for a period of 18 months, as soon as his medical condition permits. - Arm B (Control - Delayed Program): the child does not participate to the program during the first 6 months, and he joins the delayed program late after 6 months. Each child integrates the physical program for a period of one year. Regardless of the randomization arm, the child performs the initial tests, the intermediate tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be performed at 3 and 9 months. The physical activity program includes a minimum of 30 days of activities per 6 months (4days/month and a long stay). The child practice between 2 to 4 hours of activity per day. The investigators aim at demonstrating a difference of 50 meters on the total walked distance during the endurance test in the experimental group as compared to the control group after 6 months of program.

Conditions
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Cancer

Intervention / Treatment
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* Other: physical activities adapted to children


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with malignant disease Supported in service pediatric hematology-oncology child Timone hospital in Marseille. Age ≥ 5 years and ≤ 19 years No medical-cons to the practice of physical activity Exclusion Criteria: Life expectancy less than 18 months. Inability to comply with follow-up study for geographical, social or psychological. Length of stay less than 18 months, for children living outside mainland Not understanding of the French language Prior Participation in physical activity program

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>Immediate Program : the child follows the physical activity program for a period of 18 months, as soon as his medical condition permits. | Other: physical activities adapted to children<br> <br> |
| Other: Control<br>Delayed Program: the child does not participate to the program during the first 6 months, and he joins the delayed program late after 6 months. | Other: physical activities adapted to children<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of 50 meters on the total walked distance during the endurance test in the experimental group as compared to the control group after 6 months of program. |  | 6 months |