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

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ClinicalTrials.gov Identifier: NCT02284061
Recruitment Status : Unknown
Verified November 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : November 5, 2014
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Cancer Other: physical activities adapted to children

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : November 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: experimental
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
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.
Other: physical activities adapted to children


Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:   5 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284061


Contacts
Contact: Gérard MICHEL gerard.michel@ap-hm.fr

Locations
France
Assistance publique hopitaux de marseille Recruiting
Marseille, France
Contact: Gérard Michel, MD       gerard.michel@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle DESALBRES APHM
More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02284061     History of Changes
Other Study ID Numbers: 2014-25
APHM ( Other Identifier: RCAPHM14_0204 )
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015