About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Parallel
Treatments tested in this trial
Cognitively challenging physical activity for paediatric cancer patients
BehavioralThe 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.
Physical activity recommendations
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Self-regulation, assessed via Head-Toes-Knees-Shoulders-task
Self-regulation will be assessed using the Head-Toes-Knees-Shoulders task (HTKS). This task measures self-regulation by requiring participants to follow specific instructions that conflict with automatic responses. The task involves a series of instructions where participants are asked to perform actions that oppose their natural impulses. For example, they may be asked to touch their head when instructed to touch their toes or to touch their knees when told to touch their shoulders. For a wrong movement the participant gets 0, for a corrected movement 1 and for a correct movement 2 points. The score ranges from 0-60.
Frailty, assessed via Frailty Score
The frailty score is calculated to assess an individual's vulnerability and considering 5 different aspects. Weakness, slowness, shrinkage, exhaustion and diminished physical activity. These are defined by the following corresponding parameters, the hand strength measurement from the Moon Test, the 6 MWT, the triceps skinfold thickness, the PedsQL fatigue scale, as well as the PedsQL core and the BSA as well as the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). All tests are already listed and described in the outcomes. The frailty score is the composite endpoint of the named tests. The score ranges from 0 to 10, with a higher value indicating greater frailty (meaning higher Frailty worse clinical outcome).
Cardiovascular Health, assessed via Heart Rate Variability (HRV)
Heart rate variability (HRV) will be assessed using an ECG 4 activity sensor. HRV provides insights into how the heart responds to stress and relaxation. A high HRV is typically associated with better cardiovascular fitness, a more adaptable autonomic nervous system, and greater resilience to stress. Conversely, low HRV is often linked to poor health outcomes, such as higher stress levels, cardiovascular issues, and an increased risk of chronic diseases. Monitoring HRV can help assess an individual's overall well-being and autonomic nervous system functioning, as well as their response to various stressors.
Cardiovascular Health, assessed via Aortic Stiffness
Aortic Stiffness will be measured with the Mobil-O-Graph. This test helps to understand how flexible or stiff the aorta is, which is important for blood flow and blood pressure. Aortic stiffness is a key indicator of cardiovascular health, as it reflects the ability of the aorta to expand and contract with each heartbeat. Increased stiffness of the aorta can lead to higher systolic blood pressure and can be a risk factor for cardiovascular diseases.
Other outcomes
Demographic and clinical characteristics - Age
The investigators will collect data on demographic and clinical characteristics to understand the background of each participant. This includes the age of the participant. This information is needed for the overall information about the participant.
Demographic and clinical characteristics - Sex
The investigators will collect data on demographic and clinical characteristics to understand the background of each participant. This includes the sex of the participant. This information is needed for the overall information about the participant.
Demographic and clinical characteristics - Diagnosis
The investigators will collect data on demographic and clinical characteristics to understand the background of each participant. This includes the diagnosis o the participant. This information is needed for the overall information about the participant.
Demographic and clinical characteristics - Medical Treatment
The investigators will collect data on demographic and clinical characteristics to understand the background of each participant. This includes the medical treatment. This information is needed for the overall information about the participant.
Sponsors and contacts
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University of Bern
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
University Hospital, Basel, Switzerland
Collaborator