Rehabilitation Including Structured Active Play for Preschoolers With Cancer.

NCT04672681 | Active Not Recruiting

• 1 other identifier: RePlay-2020
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Cancer

Keywords

physical activity; preschool; cancer; play; social development; gross motor function

Outcome Measures

Primary Outcomes (5)

• Gross Motor Function

  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.

  Baseline (treatment initiation)

• Gross Motor Function

  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.

  3 months after treatment initiation

• Gross Motor Function

  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.

  6 months after treatment initiation (primary endpoint)

• Gross Motor Function

  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.

  12 months after treatment initiation

• Gross Motor Function

  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.

  12 months after ended treatment

Secondary Outcomes (20)

• Level of child's function in everyday life

  Baseline (treatment initiation)

• Level of child's function in everyday life

  3 months after treatment initiation

• Level of child's function in everyday life

  6 months after treatment initiation (primary endpoint)

• Level of child's function in everyday life

  12 months after treatment initiation

• Level of child's function in everyday life

  12 months after ended treatment

Other Outcomes (15)

• Child's health-related quality of life - Generic Core Scale

  Baseline (treatment initiation)

• Child's health-related quality of life - Generic Core Scale

  6 months after treatment initiation (primary endpoint)

• Child's health-related quality of life - Generic Core Scale

  12 months after treatment initiation

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive a 6-month play-based physical activity intervention with daily play and movement activities starting from treatment initiation.

Behavioral: Play-based physical activity intervention

Standard care

NO INTERVENTION

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.

Interventions

Play-based physical activity intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 12 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with mental disabilities that complicates the ability to follow instructions.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator
• Danish Child Cancer Foundation: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

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MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Hanne B Larsen

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The intervention is a parallel model where the participants are randomized to either the intervention group or standard care.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 17, 2020
• Study Start: January 7, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)