Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2026-12-31

Brief Summary

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The main objective of this study is to evaluate the evolution of the sensitivity to insulin, a hormone that acts on sugar in the body, as well as other metabolic, motor and nutritional elements of children with cancer, according to the practice of intense physical activities or stretching. In view of the scientific work on this subject, it is expect to observe that the practice of intense physical activities will improve the results of the children in the metabolic, motor and nutritional evaluations, compared to the stretching program.

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Detailed Description

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The protocol consists of 6 months of intense physical activity and stretching programs for children with solid cancer or haematological disease, starting at diagnosis. Evaluations will be performed at the first, third and sixth month of the programs and then six and eighteen months after they are stopped. The physical activity sessions will take place in the hospital during hospitalizations or by videoconference when the children are at home. The sessions are adapted to the needs, desires and abilities of the children and will take place two to three times a week. They will be mediated by various activities such as soccer, rugby, darts, muscle strengthening. Inclusion lasts two years.

Conditions

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Pediatric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized pilot study studying the parameters of two groups receiving physical activity management over a period of 6 months

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Adapted physical activity Strong

Group Type EXPERIMENTAL

Adapted Physical Activity Strong

Intervention Type OTHER

Children will practice physical activities combining aerobics and muscle strengthening. They will follow a 30-minute (for prepubescent children) or 60-minute (for pubescent children) Strong adapted physical activity session 2 to 3 times a week during hospitalization periods or by videoconference at home when they are not hospitalized.

Adapted physical activity Soft

Group Type ACTIVE_COMPARATOR

Adapted Physical Activity Strong

Intervention Type OTHER

Children will practice physical activities combining aerobics and muscle strengthening. They will follow a 30-minute (for prepubescent children) or 60-minute (for pubescent children) Strong adapted physical activity session 2 to 3 times a week during hospitalization periods or by videoconference at home when they are not hospitalized.

Interventions

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Adapted Physical Activity Strong

Children will practice physical activities combining aerobics and muscle strengthening. They will follow a 30-minute (for prepubescent children) or 60-minute (for pubescent children) Strong adapted physical activity session 2 to 3 times a week during hospitalization periods or by videoconference at home when they are not hospitalized.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age between 5 and 18 years old;
* have a solid cancer or hematological disease;
* be treated for the first time in pediatric oncology and hematology department;
* have an estimated life expectancy at diagnosis of more than 6 months.

Exclusion Criteria

* present a physical and/or psychological impossibility to follow an adapted physical activity program;
* have a pre-existing heart disease that is not suitable for adapted physical activities;
* have a known type 1 diabetes
* have an obesity defined by a body mass index greater than or equal to the International Obesity Task Force 25 threshold

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No