About this trial
Acute lymphoblastic leukemia is the most common type of cancer in children diagnosed between the ages of two and five. After cancer treatment, children suffer from fatigue and exhaustion, and thus a decrease in daily physical activity. In addition, lack of physical activity and sports causes a decrease in strength and mobility and affects coordination of movements, proprioceptive perception and balance, which can lead to the occurrence of many injuries. In addition, physical inactivity in children who have survived cancer increases the risk of cardiovascular diseases or causes overweight and obesity. In addition, the separation of children with cancer from their peers harms social, emotional, physical and school indicators of quality of life. The aim of the project is to determine the impact of 12 weeks of buddy-movement therapy on the psychomotor and social development of pediatric cancer patients in remission. The investigators expect a significant improvement in the motor skills of pediatric oncology patients in remission, specifically in fine and gross motor skills, in coordination of both hands, in body coordination, in strength and dexterity. The investigators also assume that after the introduction of 12-week buddy-movement therapy, there will be a significant improvement in the quality of life of pediatric oncology patients in remission, specifically in emotional functioning, in social functioning, in physical functioning and in school functioning. Furthermore, it is anticipated that after the introduction of 12-week buddy-movement therapy, the study will notice significant differences in motor skills between the experimental and control groups. It is also assumed that after the introduction of 12-week buddy-movement therapy, significant differences in quality of life between the experimental and control groups will be observed. The research will involve pediatric oncology patients in remission aged 5 to 12 years with acute lymphoblastic leukemia - ALL, who are treated at the Department of Pediatric Hematology and Oncology of the National Institute of Children's Diseases (NÚDCH). The research participants will undergo an entry and exit examination, including body mass index (BMI; kg/m\^2) calculated from weight (kg), height (m), waist circumference (cm), hip circumference (cm), psychomotor examination using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, and quality of life measured by the Pediatric Quality of Life Inventory. They will be divided into a control and experimental group, with the experimental group undergoing a 12-week Buddy-movement therapy focused on the development of psychomotor skills and socialization of participants using Buddy peer support.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 5-12 years
Diagnosis: acute lymphoblastic leukemia in complete remission
First-line treatment of acute lymphoblastic leukemia according to the treatment protocol
BUDDY - a healthy friend aged 5-12 years
Disqualifiers
Participation in the movement program less than 80%
Trial design
Parallel
Treatments tested in this trial
Virtual BUDDY-Movement Therapy
BehavioralBuddy - Movement Therapy (BMT) uses elements of integrative movement therapy, psychomotor therapy with activation programs and concentration psychomotor therapy depending on the training unit schedule (Hatlová 2003). The duration of buddy-movement therapy is set at 12 weeks with a frequency of 2x per week for 60 minutes. The main part of BMT will be thematic and will consist of 4 modules, adapted to the age and specifics of children: a) mainly focused on the development of fine and gross motor skills; b) development of coordination of both hands; c) development of body coordination, d) development of strength and agility. Elements of activation psychomotor therapy will be implemented in it, including gymnastic exercises, dance and expressive sequences aimed at initiating cognitive and emotional processes with an emphasis on the emotional experience of the exercise in children.
Treatment groups
Trial outcomes
Primary outcomes
Change in Motor Proficiency as measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
The BOT-2 is a standardized instrument used to measure a wide range of motor skills. The BOT-2 complete form assesses 8 subtests of motor proficiency: Fine Motor Precision, Fine Motor Integration, Manual Dexterity, Bilateral Coordination, Balance, Running Speed and Agility, Upper - Limb Coordination, and Strength. The total point score is the sum of all item scores. The total raw point score ranges from 0 to 197. A higher score indicates better motor proficiency and physical performance. Standardized scores (Scale scores and Composite scores) will also be calculated for age-normative comparison.
Change in Health-Related Quality of Life (PedsQL)
The PedsQL consist of 23 items assessing four multidimensional subscales: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). A 5-point response scale is utilized 0 = never a problem; 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0 - 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). The total score is sum of all items divided by number of items answered. Total scores range from 0 to 100, where higher scores indicate better health-related quality of life (less negative impact).
Secondary outcomes
Change in Body Mass Index (BMI)
Body mass index (BMI; kg/m\^2) will be calculated from weight (kg), height (m), waist circumference (cm), hip circumference (cm) We will also monitor waist (cm) and hip circumference (cm) to assess body composition changes.
Sponsors and contacts
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Comenius University
Lead sponsor
National Institute of Children's Diseases, Slovakia
Collaborator
Scientific Grant Agency (VEGA) of Slovakia
Collaborator