Clinical trial · Interventional
Rehabilitation Including Structured Active Play for Preschoolers With Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Play-based physical activity intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- The intervention group will receive a 6-month play-based physical activity intervention with daily play and movement activities starting from treatment initiation.
- interventionNames
- Behavioral: Play-based physical activity intervention
- type
- NO_INTERVENTION
- label
- Standard care
- description
- The control group will receive standard treatment and physiotherapy if needed. For ethical reasons, after the primary study end-point at six months, the participants and parents allocated to this group will be offered the same inspirational material and the possibility to participate in the group-based physical activity as the participants and parents allocated to the intervention group, but they will not receive education and supervision play-based physical activity with their child in the hospital room.
Primary outcomes (5)
- measure
- Gross Motor Function
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 5 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Children with mental disabilities that complicates the ability to follow instructions.
References
Publications (35)
- BACKGROUNDBjorklund DF, Brown RD. Physical play and cognitive development: integrating activity, cognition, and education. Child Dev. 1998 Jun;69(3):604-6. PMID 9680673
- BACKGROUNDBellows LL, Davies PL, Anderson J, Kennedy C. Effectiveness of a physical activity intervention for Head Start preschoolers: a randomized intervention study. Am J Occup Ther. 2013 Jan-Feb;67(1):28-36. doi: 10.5014/ajot.2013.005777. PMID 23245780
- BACKGROUNDFaigenbaum AD, Rebullido TR, MacDonald JP. Pediatric Inactivity Triad: A Risky PIT. Curr Sports Med Rep. 2018 Feb;17(2):45-47. doi: 10.1249/JSR.0000000000000450. No abstract available. PMID 29420346
- BACKGROUNDGatta G, Zigon G, Capocaccia R, Coebergh JW, Desandes E, Kaatsch P, Pastore G, Peris-Bonet R, Stiller CA; EUROCARE Working Group. Survival of European children and young adults with cancer diagnosed 1995-2002. Eur J Cancer. 2009 Apr;45(6):992-1005. doi: 10.1016/j.ejca.2008.11.042. Epub 2009 Feb 21. PMID 19231160
- BACKGROUNDSmith MA, Seibel NL, Altekruse SF, Ries LA, Melbert DL, O'Leary M, Smith FO, Reaman GH. Outcomes for children and adolescents with cancer: challenges for the twenty-first century. J Clin Oncol. 2010 May 20;28(15):2625-34. doi: 10.1200/JCO.2009.27.0421. Epub 2010 Apr 19. PMID 20404250
- BACKGROUNDGibson TM, Mostoufi-Moab S, Stratton KL, Leisenring WM, Barnea D, Chow EJ, Donaldson SS, Howell RM, Hudson MM, Mahajan A, Nathan PC, Ness KK, Sklar CA, Tonorezos ES, Weldon CB, Wells EM, Yasui Y, Armstrong GT, Robison LL, Oeffinger KC. Temporal patterns in the risk of chronic health conditions in survivors of childhood cancer diagnosed 1970-99: a report from the Childhood Cancer Survivor Study cohort. Lancet Oncol. 2018 Dec;19(12):1590-1601. doi: 10.1016/S1470-2045(18)30537-0. Epub 2018 Nov 8. PMID 30416076
- BACKGROUNDNess KK, Kaste SC, Zhu L, Pui CH, Jeha S, Nathan PC, Inaba H, Wasilewski-Masker K, Shah D, Wells RJ, Karlage RE, Robison LL, Cox CL. Skeletal, neuromuscular and fitness impairments among children with newly diagnosed acute lymphoblastic leukemia. Leuk Lymphoma. 2015 Apr;56(4):1004-11. doi: 10.3109/10428194.2014.944519. Epub 2014 Aug 20.