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NCT Number: NCT05383092

Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

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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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PASQUET Marlène

Toulouse, 31, France

Location status: Recruiting

Location contact

Marlène PASQUET, MD, PhD

CONTACT

[email protected]

0534558608

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapted Physical Activity Strong

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.

Primary outcomes

  1. Insulin Sensitivity

    Time frame: 6 months

    Homeostasis Model Assessment of Insulin Resistance

Study contacts

Contact information is provided by the study sponsor or research team.

Marlène PASQUET, MD, PhD

CONTACT

[email protected]

05 34 55 86 08 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: APACIS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 19, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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