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

NCT02284061 | Unknown

• 2 other identifiers: 2014-25APHM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (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.

  6 months

Study Arms (2)

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

OTHER

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

Interventions

physical activities adapted to children OTHER

Control; experimental

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance publique hopitaux de marseille

Marseille, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Urielle DESALBRES

  APHM

  STUDY DIRECTOR

Central Study Contacts

Gérard MICHEL

CONTACT

gerard.michel@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

FR (1)