Rehabilitation Including Structured Active Play for Preschoolers With Cancer.

Condition(s) studied

Investigational drug(s) / intervention(s)

Play-based physical activity intervention: The intervention group will participate in a six-month play-based physical activity intervention starting from their initiated treatment. The intervention combines hospital and home-based physical activity. Three days a week, there will be 45 minutes of group-based physical activity at the hospital during admissions or appointments at the outpatient clinic, supervised by an exercise professional or pediatric physiotherapist. Children who are isolated during treatment are offered supervised individual 45 min. training sessions 3 times a week as a substitute. During the other four days a week, or on days where the family is at home, the parents administer the play-based physical activity. At inclusion, the parents receive education and supervision on conducting play-based physical activity with their child in the hospital room or at home. They will receive inspiration material containing numerous different plays, games, and activities in different intensities.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Gross Motor Function — Baseline (treatment initiation)
  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.
• Gross Motor Function — 3 months after treatment initiation
  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.
• Gross Motor Function — 6 months after treatment initiation (primary endpoint)
  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.
• Gross Motor Function — 12 months after treatment initiation
  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.
• Gross Motor Function — 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.

Trial sites (1)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

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