Effect of Cognitively Challenging Physical Activity on Executive Functions in Pediatric Cancer Patients

NCT ID: NCT06839794

Last Updated: 2025-08-12

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-10

Study Completion Date

2028-12-01

Brief Summary

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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?

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

During the first phase, the intervention will commence at the Inselspital Bern, and the University Children's Hospital Basel and Aarau will serve as the control. In the second phase, after 1.5 years, a crossover will take place, and Bern will serve as the control, while the intervention takes place in Basel and Aarau.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Intervention

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

Group Type OTHER

Physical activity recommendations

Intervention Type OTHER

The children and adolescents receive general physical activity recommendations at the baseline measurement (t0). At the end of the intervention (after 12 weeks), i.e. after the final measurement (t3), they receive individualised and tailored exercise recommendations based on the test results from t0-t3.

Intervention

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.

Group Type EXPERIMENTAL

Cognitively challenging physical activity for paediatric cancer patients

Intervention Type BEHAVIORAL

The intervention is a structured cognitively challenging physical activity (PA) program specifically designed for pediatric cancer patients undergoing acute therapy. It stands out from other interventions by combining motor and cognitive tasks simultaneously. Therefore, the target executive functions are inhibition, shifting, and updating. Additionally, the whole body is addressed by enhancing PA.

The PA program spans 12 weeks, with each participant engaging in guided, supervised 45-minute sessions three times weekly. Each session includes a warm-up, the cognitive challenging PA task and a subsequent multimodal sports programme with a cool-down. Exercises are adaptive and tailored to each participant's physical and health condition by offering three levels of intensity in both cognitive and physical difficulty. In addition, exercise counselling in maintenance therapy or aftercare supports young patients to reintegrate into the life after the disease.

Interventions

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Cognitively challenging physical activity for paediatric cancer patients

The intervention is a structured cognitively challenging physical activity (PA) program specifically designed for pediatric cancer patients undergoing acute therapy. It stands out from other interventions by combining motor and cognitive tasks simultaneously. Therefore, the target executive functions are inhibition, shifting, and updating. Additionally, the whole body is addressed by enhancing PA.

The PA program spans 12 weeks, with each participant engaging in guided, supervised 45-minute sessions three times weekly. Each session includes a warm-up, the cognitive challenging PA task and a subsequent multimodal sports programme with a cool-down. Exercises are adaptive and tailored to each participant's physical and health condition by offering three levels of intensity in both cognitive and physical difficulty. In addition, exercise counselling in maintenance therapy or aftercare supports young patients to reintegrate into the life after the disease.

Intervention Type BEHAVIORAL

Physical activity recommendations

The children and adolescents receive general physical activity recommendations at the baseline measurement (t0). At the end of the intervention (after 12 weeks), i.e. after the final measurement (t3), they receive individualised and tailored exercise recommendations based on the test results from t0-t3.

Intervention Type OTHER

Other Intervention Names

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KiKli Fit Study

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valentin Benzing, Dr.

Role: STUDY_CHAIR

University Bern

Eva Brack

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Bern

Locations

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Inselspital, Universitätsspital Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Valentin Benzing, Dr.

Role: CONTACT

+ 41316844548

Eva Brack, PD Dr. Dr.

Role: CONTACT

+41 31 66 4 19 43

Facility Contacts

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Eva Brack, PD Dr. Dr.

Role: primary

+41 31 66 4 19 43

Valentin Benzing, Dr.

Role: backup

+41 316844548

Related Links

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https://www.activeoncokids.org/betroffene/trainingsbroschuere-des-naok/

Exercise Recommendations for pediatric cancer patients

Other Identifiers

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2024-00923

Identifier Type: -

Identifier Source: org_study_id

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