Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02284061
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2014-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Program in Children and Adolescents With Cancer : Assessment of Benefits on Physical, Psychological and Social Health.
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| APHM | OTHER | RCAPHM14_0204 | View |