Medulloblastoma Online Video-based Exercise Pilot Study

NCT06898684 | Recruiting

• 1 other identifier: MOVE pilot
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief Summary

In this study, the investigators test whether it is possible to deliver an exercise intervention via video meetings to children and adolescents who have completed therapy for medulloblastoma. The exercise sessions will be individualized and offered three times weekly during 12 weeks.

Conditions

Medulloblastoma, Childhood

Keywords

exercise; rehabilitation; medulloblastoma

Outcome Measures

Primary Outcomes (1)

• Feasibility of the remote assessment and a digitally delivered exercise intervention

  The researchers will test the feasibility of delivering the exercise intervention via video, defined as: 1. Adherence to the intervention by number of completed intervention sessions Acceptable level: ≥70% adherence at 6 months. 2. Data collection - feasibility of outcome measures Criteria: ≥ 90% of video-based measurements can be conducted according to protocol. ≥ 80% of PROM assessments can be completed as planned. 3. Safety Documentation of adverse events (all occurring and documented adverse events associated with the intervention will be recorded in accordance with the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.). 4. Acceptance and perceived usefulness Criterion: Qualitative analysis of interviews shows that the intervention is perceived as meaningful, feasible, and not too burdensome. 5. Technical aspects Criterion: ≥ 90% of participants can complete video sessions without major technical problems, beginning after the first three sessions.

  From enrollment to the end of exercise at 12 weeks and then for prolonged support for another 12 weeks.

Secondary Outcomes (9)

• Handgrip strength

  Change from baseline, until 3 and 12 months.

• Physical activity

  Change from baseline, until 1.5, 3, 6, and 12 months.

• Patient-reported quality of life

  Change from baseline, until 3 and 12 months.

• Motor function

  Change from baseline, until 3 and 12 months.

• Cardiorespiratory fitness

  Change from baseline, until 3 and 12 months.

Study Arms (1)

Exercise

EXPERIMENTAL

Video-supervised exercise, offered three times per week for 12 weeks, followed by behavioral support towards incorporating physical activity into daily life for an additional 12 weeks.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Moderate-high intensity exercise, with three sessions per week during 12 weeks. Includes both aerobic and resistance training and will also include exercises that strengthen coordination and balance.

Exercise

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Aron Onerup: lead
• Göteborg University: collaborator
• Uppsala University: collaborator
• Region Västerbotten: collaborator
• Region Stockholm: collaborator
• Region Östergötland: collaborator
• Region Skane: collaborator
• Technical University of Munich: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (2)

Technical University Munich

München, Germany

NOT YET RECRUITING

Queen Silvia C hildren´s Hospital

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Medulloblastoma; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Aron Onerup, MD, PhD

CONTACT

+46766185619; aron.onerup@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 27, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); DE (1)