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

NCT06839794 | Recruiting DMC

• 1 other identifier: 2024-00923
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

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

Outcome Measures

Primary Outcomes (12)

• Executive function, assessed via Hearts and Flowers Task

  The Hearts and Flowers Task is a cognitive test designed to measure executive functions, particularly inhibitory control and cognitive flexibility. The test consists of two types of conditions: In the simple condition (hearts), participants are instructed to respond on the same side as the heart appears. In the complex condition (flowers), they are instructed to respond on the opposite side of the flower's appearance. Reaction time and accuracy are recorded.

  Baseline measurement around the first 3 weeks after diagnosis

• Executive function, assessed via Hearts and Flowers Task

  The Hearts and Flowers Task is a cognitive test designed to measure executive functions, particularly inhibitory control and cognitive flexibility. The test consists of two types of conditions: In the simple condition (hearts), participants are instructed to respond on the same side as the heart appears. In the complex condition (flowers), they are instructed to respond on the opposite side of the flower's appearance. Reaction time and accuracy are recorded.

  Interim measurement (T1) 6 weeks after baseline

• Executive function, assessed via Hearts and Flowers Task

  The Hearts and Flowers Task is a cognitive test designed to measure executive functions, particularly inhibitory control and cognitive flexibility. The test consists of two types of conditions: In the simple condition (hearts), participants are instructed to respond on the same side as the heart appears. In the complex condition (flowers), they are instructed to respond on the opposite side of the flower's appearance. Reaction time and accuracy are recorded.

  Post assessment measurement (T2) 12 weeks after baseline

• Executive function, assessed via Hearts and Flowers Task

  The Hearts and Flowers Task is a cognitive test designed to measure executive functions, particularly inhibitory control and cognitive flexibility. The test consists of two types of conditions: In the simple condition (hearts), participants are instructed to respond on the same side as the heart appears. In the complex condition (flowers), they are instructed to respond on the opposite side of the flower's appearance. Reaction time and accuracy are recorded.

  Follow-up measurement (T3) 6 month after baseline

• Executive function, assessed via Fish-Flanker Task

  The Fish-Flanker Task is a cognitive test used to measure inhibitory control. Participants are shown a row of five fish and must respond to the direction of the central target fish while ignoring the surrounding flanker fish. In congruent trials, the flankers face the same direction as the target fish, while in incongruent trials, they face the opposite direction. Reaction time and accuracy are recorded.

  Baseline measurement around the first 3 weeks after diagnosis

• Executive function, assessed via Fish-Flanker Task

  The Fish-Flanker Task is a cognitive test used to measure inhibitory control. Participants are shown a row of five fish and must respond to the direction of the central target fish while ignoring the surrounding flanker fish. In congruent trials, the flankers face the same direction as the target fish, while in incongruent trials, they face the opposite direction. Reaction time and accuracy are recorded.

  Interim measurement (T1) 6 weeks after baseline

• Executive function, assessed via Fish-Flanker Task

  The Fish-Flanker Task is a cognitive test used to measure inhibitory control. Participants are shown a row of five fish and must respond to the direction of the central target fish while ignoring the surrounding flanker fish. In congruent trials, the flankers face the same direction as the target fish, while in incongruent trials, they face the opposite direction. Reaction time and accuracy are recorded.

  Post assessment measurement (T2) 12 weeks after baseline

• Executive function, assessed via Fish-Flanker Task

  The Fish-Flanker Task is a cognitive test used to measure inhibitory control. Participants are shown a row of five fish and must respond to the direction of the central target fish while ignoring the surrounding flanker fish. In congruent trials, the flankers face the same direction as the target fish, while in incongruent trials, they face the opposite direction. Reaction time and accuracy are recorded.

  Follow-up measurement (T3) 6 month after baseline

• Executive function, assessed via Corsi Block Task

  The Corsi Block Task is a cognitive test used to measure visuospatial working memory. Participants are shown a series of blocks on a screen, which light up in a specific sequence. The task requires replicating the sequence by tapping the blocks in the same order (forward condition) or in reverse order (backward condition). The length of the sequence increases after each correct attempt. The score is the longest correctly repeated sequence, ranging from 0 (no correct sequences) to 10 or more (longer sequences). The outcome measures include the total number of correctly recalled sequences, the achieved Block Span, the z-score of the Block Span and the percentile of the Block Span. Additionally, they include a summary score calculated as the product of the Block Span and the total number of correct sequences, the z-score of this total score and the percentile of the total score.

  Baseline measurement around the first 3 weeks after diagnosis

• Executive function, assessed via Corsi Block Task

  The Corsi Block Task is a cognitive test used to measure visuospatial working memory. Participants are shown a series of blocks on a screen, which light up in a specific sequence. The task requires replicating the sequence by tapping the blocks in the same order (forward condition) or in reverse order (backward condition). The length of the sequence increases after each correct attempt. The score is the longest correctly repeated sequence, ranging from 0 (no correct sequences) to 10 or more (longer sequences). The outcome measures include the total number of correctly recalled sequences, the achieved Block Span, the z-score of the Block Span and the percentile of the Block Span. Additionally, they include a summary score calculated as the product of the Block Span and the total number of correct sequences, the z-score of this total score and the percentile of the total score.

  Interim measurement (T1) 6 weeks after baseline

• Executive function, assessed via Corsi Block Task

  The Corsi Block Task is a cognitive test used to measure visuospatial working memory. Participants are shown a series of blocks on a screen, which light up in a specific sequence. The task requires replicating the sequence by tapping the blocks in the same order (forward condition) or in reverse order (backward condition). The length of the sequence increases after each correct attempt. The score is the longest correctly repeated sequence, ranging from 0 (no correct sequences) to 10 or more (longer sequences). The outcome measures include the total number of correctly recalled sequences, the achieved Block Span, the z-score of the Block Span and the percentile of the Block Span. Additionally, they include a summary score calculated as the product of the Block Span and the total number of correct sequences, the z-score of this total score and the percentile of the total score.

  Post assessment measurement (T2) 12 weeks after baseline

• Executive function, assessed via Corsi Block Task

  The Corsi Block Task is a cognitive test used to measure visuospatial working memory. Participants are shown a series of blocks on a screen, which light up in a specific sequence. The task requires replicating the sequence by tapping the blocks in the same order (forward condition) or in reverse order (backward condition). The length of the sequence increases after each correct attempt. The score is the longest correctly repeated sequence, ranging from 0 (no correct sequences) to 10 or more (longer sequences). The outcome measures include the total number of correctly recalled sequences, the achieved Block Span, the z-score of the Block Span and the percentile of the Block Span. Additionally, they include a summary score calculated as the product of the Block Span and the total number of correct sequences, the z-score of this total score and the percentile of the total score.

  Follow-up measurement (T3) 6 month after baseline

Secondary Outcomes (25)

• Self-regulation, assessed via Head-Toes-Knees-Shoulders-task

  Baseline measurement around the first 3 weeks after diagnosis; interim measurement (T1) 6 weeks after baseline; post assessment measurement (T2) 12 weeks after baseline; follow-up measurement (T3) 6 month after baseline

• Frailty, assessed via Frailty Score

  Baseline measurement around the first 3 weeks after diagnosis; interim measurement (T1) 6 weeks after baseline; post assessment measurement (T2) 12 weeks after baseline; follow-up measurement (T3) 6 month after baseline

• Cardiovascular Health, assessed via Heart Rate Variability (HRV)

  Baseline measurement around the first 3 weeks after diagnosis; interim measurement (T1) 6 weeks after baseline; post assessment measurement (T2) 12 weeks after baseline; follow-up measurement (T3) 6 month after baseline

• Cardiovascular Health, assessed via Aortic Stiffness

  Baseline measurement around the first 3 weeks after diagnosis; interim measurement (T1) 6 weeks after baseline; post assessment measurement (T2) 12 weeks after baseline; follow-up measurement (T3) 6 month after baseline

• Cardiovascular Health, assessed via 6-Minute Walk Test

  Baseline measurement around the first 3 weeks after diagnosis; interim measurement (T1) 6 weeks after baseline; post assessment measurement (T2) 12 weeks after baseline; follow-up measurement (T3) 6 month after baseline

Other Outcomes (4)

• Demographic and clinical characteristics - Age

  Baseline measurement around the first 3 weeks after diagnosis

• Demographic and clinical characteristics - Sex

  Baseline measurement around the first 3 weeks after diagnosis

• Demographic and clinical characteristics - Diagnosis

  Baseline measurement around the first 3 weeks after diagnosis

Study Arms (2)

Control Intervention

OTHER

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

Other: Physical activity recommendations

Intervention

EXPERIMENTAL

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.

Behavioral: Cognitively challenging physical activity for paediatric cancer patients

Interventions

Cognitively challenging physical activity for paediatric cancer patients 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.

Also known as: KiKli Fit Study

Intervention

Physical activity recommendations 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.

Control Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (1)

• Schneider AC, Hillebrecht L, Rehbein L, Schmid J, Pallivathukal S, von der Weid N, Furtwangler R, Brekenfeld RE, Greiner J, Schindera C, Brack EK, Benzing V. Smart exercise in pediatric oncology: enhancing executive functions through cognitively challenging physical activity- a non-randomized controlled trial. BMC Cancer. 2025 Dec 5;26(1):75. doi: 10.1186/s12885-025-15303-5.

  PMID: 41351152 DERIVED

Related Links

• Exercise Recommendations for pediatric cancer patients

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Valentin Benzing, Dr.

  University Bern

  STUDY CHAIR

• Eva Brack

  University Children's Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentin Benzing, Dr.

CONTACT

+ 41316844548; valentin.benzing@unibe.ch

Eva Brack, PD Dr. Dr.

CONTACT

+41 31 66 4 19 43; eva.brack@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 21, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The IPD will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal will be able to assess the data. The data will be shared to achieve the aims of the provided proposal. BORIS, osf.io or Zenodo will be used to share the data after deidentification (text, tables, figures, and appendices).

Locations

CH (1)