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

NCT ID: NCT02284061

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-11-30

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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experimental

Immediate Program : the child follows the physical activity program for a period of 18 months, as soon as his medical condition permits.

Group Type EXPERIMENTAL

physical activities adapted to children

Intervention Type OTHER

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.

Group Type OTHER

physical activities adapted to children

Intervention Type OTHER

Interventions

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physical activities adapted to children

Intervention Type OTHER

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urielle DESALBRES

Role: STUDY_DIRECTOR

APHM

Locations

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Assistance publique hopitaux de marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gérard MICHEL

Role: CONTACT

[email protected]

Facility Contacts

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Gérard Michel, MD

Role: primary

[email protected]

Other Identifiers

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APHM

Identifier Type: OTHER

Identifier Source: secondary_id

2014-25

Identifier Type: -

Identifier Source: org_study_id