Clinical trial NCT06839794: Effect of Cognitively Challenging Physical Activity on Executive Functions in Pediatric Cancer Patients
Official title: An Investigator Initiated, Non-randomized Controlled Trial on the Effect of Cognitively Challenging Physical Activity on Executive Functions in Paediatric Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Childhood Cancer
Cancer-related Problem/Condition
Cognitive Side Effects of Cancer Therapy
Physical Activity
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: University Hospital, Basel, Switzerland
First posted: 2025-02-21
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Executive function, assessed via Hearts and Flowers Task
timeFrame: Baseline measurement around the first 3 weeks after diagnosis
measure: Executive function, assessed via Hearts and Flowers Task
timeFrame: Interim measurement (T1) 6 weeks after baseline
measure: Executive function, assessed via Hearts and Flowers Task
timeFrame: Post assessment measurement (T2) 12 weeks after baseline
measure: Executive function, assessed via Hearts and Flowers Task
timeFrame: Follow-up measurement (T3) 6 month after baseline
measure: Executive function, assessed via Fish-Flanker Task
timeFrame: Baseline measurement around the first 3 weeks after diagnosis
measure: Executive function, assessed via Fish-Flanker Task
timeFrame: Interim measurement (T1) 6 weeks after baseline
measure: Executive function, assessed via Fish-Flanker Task
timeFrame: Post assessment measurement (T2) 12 weeks after baseline
measure: Executive function, assessed via Fish-Flanker Task
timeFrame: Follow-up measurement (T3) 6 month after baseline
measure: Executive function, assessed via Corsi Block Task
timeFrame: Baseline measurement around the first 3 weeks after diagnosis
measure: Executive function, assessed via Corsi Block Task
timeFrame: Interim measurement (T1) 6 weeks after baseline
measure: Executive function, assessed via Corsi Block Task
timeFrame: Post assessment measurement (T2) 12 weeks after baseline
measure: Executive function, assessed via Corsi Block Task
timeFrame: Follow-up measurement (T3) 6 month after baseline
Secondary outcomes:
measure: Self-regulation, assessed via Head-Toes-Knees-Shoulders-task
timeFrame: 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
measure: Frailty, assessed via Frailty Score
timeFrame: 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
measure: Cardiovascular Health, assessed via Heart Rate Variability (HRV)
timeFrame: 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
measure: Cardiovascular Health, assessed via Aortic Stiffness
timeFrame: 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
measure: Cardiovascular Health, assessed via 6-Minute Walk Test
timeFrame: 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
measure: Body composition, assessed via Triceps Skin-Fold Thickness
timeFrame: 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
measure: Health-Related Quality of Life, assessed via PedsQL
timeFrame: 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
measure: Cancer related fatigue, assessed via PedsQL Fatigue Module
timeFrame: 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
measure: Physical Self-Concept, assessed via PSDQ-S
timeFrame: 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
measure: Physical Activity Enjoyment, assessed via PACES-S
timeFrame: 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
measure: Functional Appreciation, assessed via FAS
timeFrame: 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
measure: Motor abilities, assessed via Moon Test
timeFrame: 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
measure: Postural Balance, assessed via Force Plate
timeFrame: 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
measure: Physical Activity, assessed via BSA
timeFrame: 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
measure: Physical Activity, assessed via GSLTPAQ
timeFrame: 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
measure: Physical activity assessed via movement accelerometers
timeFrame: Only at interim measurement (T1) 6 weeks after baseline measurement for 7 consecutive days
measure: Affective experiences, assessed via the Self-Assessment Manikin (SAM)
timeFrame: Only at interim measurement (T1) 6 weeks after baseline measurement for 7 consecutive days
measure: Affective experiences and cancer related side effects, assessed via Present Functioning Visual Analogue Scales (PEDSQL VAS)
timeFrame: Only at interim measurement (T1) 6 weeks after baseline measurement for 7 consecutive days
measure: Current activity, assessed via e-diaries
timeFrame: Only at interim measurement (T1) 6 weeks after baseline measurement for 7 consecutive days
measure: Muscle Mass (Body composition), assessed via Bioelectrical Impedance Analysis
timeFrame: 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
measure: Fat-Free Mass (Body composition), assessed via Bioelectrical Impedance Analysis
timeFrame: 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
measure: Fat Mass (Body composition), assessed via Bioelectrical Impedance Analysis
timeFrame: 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
measure: Feasibility of intervention, assessed via a self-developed questionnaire and semi-structured interviews
timeFrame: 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
measure: Exercise adherence, assessed via exercise diary
timeFrame: During the intervention, expected to be on average 5 minutes
measure: Feasibility of intervention
timeFrame: During the intervention, up to 6 months
Other outcomes:
measure: Demographic and clinical characteristics - Age
timeFrame: Baseline measurement around the first 3 weeks after diagnosis
measure: Demographic and clinical characteristics - Sex
timeFrame: Baseline measurement around the first 3 weeks after diagnosis
measure: Demographic and clinical characteristics - Diagnosis
timeFrame: Baseline measurement around the first 3 weeks after diagnosis
measure: Demographic and clinical characteristics - Medical Treatment
timeFrame: Through individual study completion, an average of 6 to 8 months.
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
Study officials:
affiliation: University Bern
name: Valentin Benzing, Dr.
role: STUDY_CHAIR
affiliation: University Children's Hospital Bern
name: Eva Brack
role: PRINCIPAL_INVESTIGATOR
References: