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

Официальное название

An Investigator Initiated, Non-randomized Controlled Trial on the Effect of Cognitively Challenging Physical Activity on Executive Functions in Paediatric Cancer Patients

Обзор

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?

Вмешательства

• Поведенческое 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 sess
• Другое 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.

Первичные конечные точки

• Executive function, assessed via Hearts and Flowers Task [Срок оценки: Baseline measurement around the first 3 weeks after diagnosis]
• Executive function, assessed via Hearts and Flowers Task [Срок оценки: Interim measurement (T1) 6 weeks after baseline]
• Executive function, assessed via Hearts and Flowers Task [Срок оценки: Post assessment measurement (T2) 12 weeks after baseline]
• Executive function, assessed via Hearts and Flowers Task [Срок оценки: Follow-up measurement (T3) 6 month after baseline]
• Executive function, assessed via Fish-Flanker Task [Срок оценки: Baseline measurement around the first 3 weeks after diagnosis]
• Executive function, assessed via Fish-Flanker Task [Срок оценки: Interim measurement (T1) 6 weeks after baseline]
• Executive function, assessed via Fish-Flanker Task [Срок оценки: Post assessment measurement (T2) 12 weeks after baseline]
• Executive function, assessed via Fish-Flanker Task [Срок оценки: Follow-up measurement (T3) 6 month after baseline]
• Executive function, assessed via Corsi Block Task [Срок оценки: Baseline measurement around the first 3 weeks after diagnosis]
• Executive function, assessed via Corsi Block Task [Срок оценки: Interim measurement (T1) 6 weeks after baseline]

Вторичные конечные точки (12)

• Self-regulation, assessed via Head-Toes-Knees-Shoulders-task [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]
• Body composition, assessed via Triceps Skin-Fold Thickness [Срок оценки: 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]
• Health-Related Quality of Life, assessed via PedsQL [Срок оценки: 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]
• Cancer related fatigue, assessed via PedsQL Fatigue Module [Срок оценки: 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]
• Physical Self-Concept, assessed via PSDQ-S [Срок оценки: 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]
• Physical Activity Enjoyment, assessed via PACES-S [Срок оценки: 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]
• Functional Appreciation, assessed via FAS [Срок оценки: 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]
• Motor abilities, assessed via Moon Test [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Швейцария · 1 центр

• Inselspital, Universitätsspital Bern — Bern

Публикации

• 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

Идентификаторы

NCT: NCT06839794 · 2024-00923

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗