Effect of Cognitively Challenging Physical Activity on Executive Functions in Pediatric Cancer Patients (KiKli Fit)

University of Bern

Status: Enrolling

Conditions: Physical Activity; Cancer-related Problem/Condition; Childhood Cancer; Cognitive Side Effects of Cancer Therapy

Treatments: Other: Physical activity recommendations; Behavioral: Cognitively challenging physical activity for paediatric cancer patients

Study type: Interventional

Funder types: Other

Identifiers

NCT06839794

2024-00923

Details and patient eligibility

About

When it comes to exercise and sport for children and adolescents with cancer, there is often still the opinion that physical activity has a negative effect on the weakened body suffering from cancer. Many studies show that the opposite is the case: physical activity for children and adolescents with cancer do not jeopardise the success of treatment, but rather promote it. It has been shown that physical activity has a positive effect on motor skills, physical fitness, sleep quality, fatigue symptoms, body image and general quality of life in children and adolescents with cancer.

In addition, physical activity leads to an improved fat-to-muscle ratio, metabolic status, bone strength and reduces cardiovascular disease. Furthermore, various studies show that oncological patients with sarcopenia (loss of muscle mass) and frailty have a poorer response to their cancer therapy. This broad spectrum of effects of physical activity leads to improved and faster rehabilitation, is directly linked to the success of treatment and has led to exercise being an integral part of treatment in many paediatric oncology centres worldwide.

Furthermore, more exercise that includes playful cognitive tasks is expected to lead to improved attention, memory and academic achievement. Besides, it is important to try to get children to exercise at home outside of the inpatient setting. Hybrid (on-site and digital meetings) programmes also work for children and adolescents. Additionally, the research project offers sports counselling after the end of therapy to reintegrate the patients into everyday sporting life, be it in a club or at school.

The central question of the research project is: Does cognitive challenging physical activity developed for children and adolescents undergoing acute cancer therapy improve cognitive and motor performance compared to a control group receiving standard care?

Enrollment: 70 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent of parents / legal guardian and participants, where applicable
• Diagnosis of any type of cancer requiring chemo- and/or radiotherapy, or CNS surgery, expected to last a minimum of at least 6 weeks at the time of recruitment
• Age: 6-17.99 years at time of recruitment

Exclusion criteria

• Cognitive and physical disabilities that prevent participation in the intervention.
• Inability to follow the procedures of the study, e.g. due to language problems.
• Enrolment of the investigator, his/her family members, employees and other dependent persons.
• Denied written informed consent from participants.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Control Intervention

Other group

Description:

Participants have access to standard care as usual and receive physical activity recommendations.

Treatment:

Other: Physical activity recommendations

Intervention

Experimental group

Description:

The intervention is a cognitively challenging physical activity (PA) intervention for children and adolescents with cancer undergoing acute therapy. The intervention is based on the "S2k Guideline: Promotion of Exercise and Exercise Therapy in Paediatric Oncology" and the international Paediatric Oncology Exercise Guidelines. And on study results and experience from previous cognitive challenging PA intervention studies.

Treatment:

Behavioral: Cognitively challenging physical activity for paediatric cancer patients