Rehabilitation Including Structured Active Play for Preschoolers With Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Gross Motor Function
研究概览
简要总结
Treatment for childhood cancer causes treatment-related acute adverse events such as muscle weakness and physical incompetence. With long admissions, isolation, and long-term bed rest, this means reduced physical activity and, ultimately, gross motor functioning development is affected. Furthermore, the children participate less in sport and leisure activities, inhibiting social skills, and the children feel isolated from peers. The above makes it difficult for children to return to everyday activities. Physical activity in the form of play and movement activities is essential for preschool children's gross motor, social, and personal development- a development where parents play a crucial role.
Replay is a randomized controlled trial that will include 84 children with cancer aged 1-5 years at the University Hospital Copenhagen, Rigshospitalet. The children are included at the treatment initiation and are randomized to either the intervention group or the control group. The intervention consists of six months of daily structured play-based physical activity, including daily parent administered play and movement and three weekly group-based play and movement sessions at the hospital during admissions. Gross motor and physical function is measured with 1) Peabody Developmental Motor Scales, Second Edition (PDMS-2), Pediatric Evaluation of Disability Inventory (PEDI), Handgrip strength, and a six-minute walk test. The assessment time points are baseline (initiated timepoint), 3- and 6 months (endpoint) after initiated treatment. The intervention group will be observed and invited to participate in qualitative interviews. The control group will receive usual care and specific physiotherapy if needed.
详细描述
Aim
Project RePlay aims to investigate the effectiveness of a play-based physical activity intervention on gross motor functioning measured by Peabody Developmental Motor Scales, Second Edition (PDMS-2) with the primary end-point six months after diagnosis in children with newly diagnosed cancer aged 1-5 years old. The investigators hypothesize that the intervention will reduce short- and long-term physical and psychosocial consequences, including reduced gross motor function and lack of social interaction.
- Background
Physical play and movement activities are essential for preschool children's gross motor, social, and personal development. Through play and movement, children develop motor skills crucial for participation in physical and social activities throughout life. A study showed that an 18-week play intervention among healthy preschool children significantly improved (p<.0005) gross motor function in the intervention group compared with the control group. Play is also the children's first arena for socializing, and these interactions have an immense role in developing emotional, personal, and social skills. Physical play and movement activities are more than just physical exercise; it is social teamwork, emotions, and learning. Reduced physical activity or inactivity in children is highly dependent on three factors; 1) reduced dynapenia (muscle strength and power), 2) exercise deficit disorder (physical inactivity), and 3) physical illiteracy (reduced competence, confidence, and knowledge in movement). Due to more intensive treatment with chemotherapy, radiation, and surgery, children with cancer experience acute adverse events such as myopathy and neuropathy, resulting in muscle weakness, physical incompetence, and inactivity. Furthermore, treatment-related complications such as infections can cause extended periods of hospitalization, periods of isolation, and long-term bed rest. Thus, many children with cancer experience several physical side effects as impaired motor skills, physical capacity, and decreased motivation to engage in physical activity. The cancer treatment has a significant impact on the children's physical development and socialization as the lack of motor development leads to inactivity and less participation in sport and leisure activities. This leads to a reduced understanding of the social playing field in joint activities, and the children feel more isolated from peers. Children with cancer experiences challenges in all three factors leading to physical inactivity. Compared with siblings and the general population, these social and physical challenges persist for the rest of their lives. Hence, children diagnosed with cancer have lower school performance, lower education level, higher unemployment, and increased socioeconomic challenges. Thus, the investigators hypothesize that early initiated rehabilitation programs during initial treatment, focusing on maintaining a typical physical activity level, are crucial for continuing everyday activities during and after treatment.
The rehabilitation, including social and physical activity and education in children and teenagers with cancer (RESPECT) study for children with cancer aged 6-18 years, showed that it is feasible to carry out physical tests and motivate them to participate in physical activities. Physical activity maintained the hospitalized children's physical fitness and gross motor function during treatment compared with hospitalized children who did not receive physical activity intervention. A systematic review covering international studies show similar findings; that physical activities positively affect mobility, physical fitness, muscle strength, and quality of life in children with cancer. Additionally, children with cancer who participate in structured physical activities during treatment have fewer admission days than children who received standard care, corresponding to a 17% reduction in hospitalization's total economic cost. Most studies focusing on physical activity as part of an early initiated rehabilitation program designed interventions for school children aged 6-18. Only a few of the studies include children under the age of 6 years. Each year 200 children and adolescents aged 0-18 years are diagnosed with cancer in Denmark. Of these, approximately one-third is diagnosed before the age of 5. None of the published studies on physical activity in pediatric oncology designed interventions for preschool children (1-5 years old). Thus, there is a lack of studies with an intervention designed for preschool children with cancer focusing on physical and social rehabilitation. Improvements in cure-rates of childhood cancer mean that today's 5-year survival is 85%. Thus, more research into the best strategies for physical activity and rehabilitation for all age groups of children with cancer is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with cancer or benign disorders and are being treated with chemotherapy and/or radiation and are admitted to the Department of Pediatric Hematology/Oncology at University Hospital Copenhagen, Rigshospitalet.
- •Children at the age of 1-5,9 years at diagnosis.
- •Children whose parents can communicate in Danish.
排除标准
- •Children with mental disabilities that complicates the ability to follow instructions.
结局指标
主要结局
Gross Motor Function
时间窗: 12 months after ended treatment
Gross Motor Function is measured with the gross motor function subscale of Peabody Developmental Motor Scales, Second Edition (PDMS-2). PDMS-2 gives a gross motor standard score summed by the standard score from the three gross motor domians; stationary, locomotion and object manipulation. The primary endpoint is after six months.
次要结局
- Level of child's function in everyday life(12 months after ended treatment)
- Six-minute walk(12 months after ended treatment)
- Handgrip strength(12 months after ended treatment)
- Two-minute walk(12 months after ended treatment)
研究者
Hanne Baekgaard Larsen
Associate Professor
Rigshospitalet, Denmark
