TY - JOUR

T1 - Rehabilitation including structured active play for preschoolers with cancer (RePlay) — study protocol for a randomized controlled trial

AU - Pouplier, Anna

AU - Winther, Helle

AU - Christensen, Jan

AU - Schmidt-Andersen, Peter

AU - Zhang, He

AU - Frandsen, Thomas Leth

AU - Schmiegelow, Kjeld

AU - Fridh, Martin Kaj

AU - Larsen, Hanne Bækgaard

N1 - CURIS 2022 NEXS 127

PY - 2022

Y1 - 2022

N2 - Background: Children diagnosed with cancer experience muscle weakness and impaired physical function caused by treatment and related immobility. The situation forces them into a negative cycle of diminished participation in physical and leisure activities and isolation from peers; inhibiting the natural development of social and gross motor skills. This manuscript presents a protocol for a study that explores the effects of using structured active play to maintain preschoolers' age specific gross motor function and social and personal skills while undertaking intensive cancer treatment.Methods: The study is a two-arm, superiority randomized controlled trial with an intervention and a control group designed to evaluate the effects of a structured active play intervention on gross motor function. Gross motor subtests of the Peabody Developmental Motor Scales, Second Edition (PDMS-2) are used for measurement; with the primary end-point at 6 months post-treatment initiation. Eighty-four preschool children (aged 1–5 years), newly diagnosed with cancer at the Copenhagen University Hospital are randomly assigned to either an intervention or control group, using a 1:1 allocation. The intervention group receives a combined in-hospital and home-based program that includes structured active play activities, while the control group receives standard care, including physiotherapy. During hospital admission, the intervention group undertakes 45-min structured active play group sessions three times weekly, conducted by exercise professionals. Parents receive training and supervision to facilitate daily individual sessions outside of group sessions. Secondary study outcomes target the children's overall function level in everyday life, general physical performance, and health-related quality of life. As well, children's and parents' experiences within the intervention are explored and the children's social and personal development is observed.Discussion: Limited evidence exists regarding the effectiveness of rehabilitation interventions, particularly those including active play, for preschoolers diagnosed with cancer. This manuscript reporting on a study protocol will enhance clarity and transparency in reporting and offer insights for others with interest in this same topic. Once completed, findings from this study could extend knowledge about the conduct and measurement of effectiveness in rehabilitation initiatives. If study findings suggest that the intervention is effective, structured active play may become a standard part of rehabilitation.Trial Registration: ClinicalTrials.gov: NCT04672681. Registered December 17, 2020. https://clinicaltrials.gov/ct2/show/NCT04672681.

AB - Background: Children diagnosed with cancer experience muscle weakness and impaired physical function caused by treatment and related immobility. The situation forces them into a negative cycle of diminished participation in physical and leisure activities and isolation from peers; inhibiting the natural development of social and gross motor skills. This manuscript presents a protocol for a study that explores the effects of using structured active play to maintain preschoolers' age specific gross motor function and social and personal skills while undertaking intensive cancer treatment.Methods: The study is a two-arm, superiority randomized controlled trial with an intervention and a control group designed to evaluate the effects of a structured active play intervention on gross motor function. Gross motor subtests of the Peabody Developmental Motor Scales, Second Edition (PDMS-2) are used for measurement; with the primary end-point at 6 months post-treatment initiation. Eighty-four preschool children (aged 1–5 years), newly diagnosed with cancer at the Copenhagen University Hospital are randomly assigned to either an intervention or control group, using a 1:1 allocation. The intervention group receives a combined in-hospital and home-based program that includes structured active play activities, while the control group receives standard care, including physiotherapy. During hospital admission, the intervention group undertakes 45-min structured active play group sessions three times weekly, conducted by exercise professionals. Parents receive training and supervision to facilitate daily individual sessions outside of group sessions. Secondary study outcomes target the children's overall function level in everyday life, general physical performance, and health-related quality of life. As well, children's and parents' experiences within the intervention are explored and the children's social and personal development is observed.Discussion: Limited evidence exists regarding the effectiveness of rehabilitation interventions, particularly those including active play, for preschoolers diagnosed with cancer. This manuscript reporting on a study protocol will enhance clarity and transparency in reporting and offer insights for others with interest in this same topic. Once completed, findings from this study could extend knowledge about the conduct and measurement of effectiveness in rehabilitation initiatives. If study findings suggest that the intervention is effective, structured active play may become a standard part of rehabilitation.Trial Registration: ClinicalTrials.gov: NCT04672681. Registered December 17, 2020. https://clinicaltrials.gov/ct2/show/NCT04672681.

KW - Faculty of Science

KW - Preschool children

KW - Rehabilitation

KW - Structured active play

KW - Physical activity

KW - Gross motor function

KW - Social skills

KW - Randomized

KW - Pediatric oncology

KW - Study protocol

U2 - 10.3389/fped.2022.834512

DO - 10.3389/fped.2022.834512

M3 - Journal article

C2 - 35615627

VL - 10

JO - Frontiers in Pediatrics

JF - Frontiers in Pediatrics

SN - 2296-2360

M1 - 834512

ER -