An Investigator Initiated, Non-randomized Controlled Trial on the Effect of Cognitively Challenging Physical Activity on Executive Functions in Paediatric Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Executive function, assessed via Hearts and Flowers Task
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control Intervention
Participants have access to standard care as usual and receive physical activity recommendations.
干预措施: Physical activity recommendations (Other)
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.
干预措施: Cognitively challenging physical activity for paediatric cancer patients (Behavioral)
结局指标
主要结局
Executive function, assessed via Hearts and Flowers Task
时间窗: Follow-up measurement (T3) 6 month after baseline
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 Fish-Flanker Task
时间窗: Follow-up measurement (T3) 6 month after baseline
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.
Executive function, assessed via Corsi Block Task
时间窗: Follow-up measurement (T3) 6 month after baseline
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.
Executive function, assessed via Hearts and Flowers Task
时间窗: Baseline measurement around the first 3 weeks after diagnosis
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
时间窗: Interim measurement (T1) 6 weeks after baseline
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
时间窗: Post assessment measurement (T2) 12 weeks after baseline
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 Fish-Flanker Task
时间窗: Baseline measurement around the first 3 weeks after diagnosis
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.
Executive function, assessed via Fish-Flanker Task
时间窗: Interim measurement (T1) 6 weeks after baseline
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.
Executive function, assessed via Fish-Flanker Task
时间窗: Post assessment measurement (T2) 12 weeks after baseline
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.
Executive function, assessed via Corsi Block Task
时间窗: Baseline measurement around the first 3 weeks after diagnosis
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.
Executive function, assessed via Corsi Block Task
时间窗: Interim measurement (T1) 6 weeks after baseline
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.
Executive function, assessed via Corsi Block Task
时间窗: Post assessment measurement (T2) 12 weeks after baseline
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.
次要结局
- 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)
- Body composition, assessed via Triceps Skin-Fold Thickness(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(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(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(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(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(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(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)
- Postural Balance, assessed via Force Plate(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, assessed via BSA(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, assessed via GSLTPAQ(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 assessed via movement accelerometers(Only at interim measurement (T1) 6 weeks after baseline measurement for 7 consecutive days)
- Affective experiences, assessed via the Self-Assessment Manikin (SAM)(Only at interim measurement (T1) 6 weeks after baseline measurement for 7 consecutive days)
- Affective experiences and cancer related side effects, assessed via Present Functioning Visual Analogue Scales (PEDSQL VAS)(Only at interim measurement (T1) 6 weeks after baseline measurement for 7 consecutive days)
- Current activity, assessed via e-diaries(Only at interim measurement (T1) 6 weeks after baseline measurement for 7 consecutive days)
- Muscle Mass (Body composition), assessed via Bioelectrical Impedance Analysis(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)
- Fat-Free Mass (Body composition), assessed via Bioelectrical Impedance Analysis(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)
- Fat Mass (Body composition), assessed via Bioelectrical Impedance Analysis(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)
- Feasibility of intervention, assessed via a self-developed questionnaire and semi-structured interviews(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)
- Exercise adherence, assessed via exercise diary(During the intervention, expected to be on average 5 minutes)
- Feasibility of intervention(During the intervention, up to 6 months)