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Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05383092
Acronym
APACIS
Enrollment
60
Registered
2022-05-19
Start date
2022-07-11
Completion date
2026-12-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

Keywords

pediatric cancers, exercise, insulin sensibility, metabolic syndrome

Brief summary

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.

Detailed description

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.

Interventions

OTHERAdapted 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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin Sensitivity6 monthsHomeostasis Model Assessment of Insulin Resistance

Countries

France

Contacts

Primary ContactMarlène PASQUET, MD, PhD
pasquet.m@chu-toulouse.fr05 34 55 86 08

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026