Medulloblastoma Online Video-based Exercise Pilot Study (MOVE)

Medulloblastoma Online Video-based Exercise Pilot Study (MOVE)

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.

Study Overview

• Status: Recruiting
• Conditions: Medulloblastoma, Childhood
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

Tumors of the central nervous system (CNS) represent 25-30% of all cases of pediatric cancer in Sweden. The survival for children with a brain tumor has improved over the last years. The 5-year overall survival rate is now 70%, resulting in a growing number or survivors every year. Malignant brain tumors typically have a poor prognosis, and curative treatment usually requires a combination of neurosurgery, chemotherapy and/or radiotherapy. For the survivors, the cure often comes at the cost of long-term side effects. Finding effective ways to mitigate the long-term side effects after childhood brain tumor is important, since they can severely impact the survivors´ daily life.

There is growing evidence that physical exercise is beneficial to cognition and improves cardiorespiratory fitness and motor function. It appears to be important that interventions start early, within 1-2 years after radiotherapy. For this to be feasible in international multicenter trials, the intervention and outcome assessments will need to be delivered remotely. Whether this is feasible in children treated for medulloblastoma is not known.

The investigators will perform a pilot study to provide pivotal information on whether exercise training can be remotely delivered in the home environment in children treated for medulloblastoma. This will take exercise training from an interesting research concept into a scalable intervention that can be offered regardless of geographic location of the patient. The study will further define the validity and feasibility of in-home outcome assessments of cardiorespiratory, muscular fitness and motor function in children treated for medulloblastoma. If shown feasible, this will work as a proof-of-concept and lead the way for including physical activity intervention in other childhood cancer treatment protocols as well. The results from this study will also enable the researchers to proceed in the planning of the first exercise intervention to be included upfront in an international childhood cancer treatment protocol, the upcoming Pan-European treatment protocol for standard-risk medulloblastoma in children (SIOP-MB6).

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aron Onerup, MD, PhD; Phone Number: +46766185619; Email: aron.onerup@gu.se

Study Locations

• Germany
  • München, Germany
    • Not yet recruiting
    • Technical University Munich
    • Contact: Sabine Kesting, PhD; Email: sabine.kusting@tum.de
• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Queen Silvia C hildren´s Hospital
    • Contact: Aron Onerup, MD, PhD; Phone Number: +46313421000; Email: aron.onerup@gu.se
    • Principal Investigator: Aron Onerup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Completed therapy for medulloblastoma, including craniospinal radiation therapy, within 36 months before study entry.

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Exclusion Criteria: Inability to walk without support. Progressive disease.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Adherence to the intervention by number of completed intervention sessions Acceptable level: ≥70% adherence at 6 months.; 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.; 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.).; Acceptance and perceived usefulness Criterion: Qualitative analysis of interviews shows that the intervention is perceived as meaningful, feasible, and not too burdensome.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Measured with a hand dynamometer	Change from baseline, until 3 and 12 months.
Physical activity	Activity counts per day, registered with accelerometry (Fibion Sens)	Change from baseline, until 1.5, 3, 6, and 12 months.
Patient-reported quality of life	Measured with Patient-Reported Outcomes Measurement Information System (PROMIS)-25.	Change from baseline, until 3 and 12 months.
Cardiorespiratory fitness	Assessed with the 3-min step in place test	Change from baseline, until 3 and 12 months.
Epigenetic age acceleration	Epigenetic age will be determined from DNA methylation analyses of DNA extracted from saliva samples.	Change from baseline, until 3 and 12 months.
Feasibility of the outcome measures	The researchers will develop the outcome assessments battery by removing outcome assessments that are not feasible through video.	12 weeks
Cognitive function	Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function 7a.	Change from baseline to 12 weeks and 12 months.
Lower limb strength	We will assess lower limb strength with the five repetition sit-to-stand test, assessed with the number of seconds to perform the test. The same chair will be used across all time points.	Change from baseline until 3 and 12 months.
Motor function	Assessed with the brief ataxia rating scale (BARS), higher numbers indicate worse outcomes.	Change from baseline, until 3 and 12 months.

Collaborators and Investigators

• Sponsor: Aron Onerup
• Collaborators: Uppsala University; Göteborg University; Region Östergötland; Technical University of Munich; Region Skane; Region Stockholm; Universitätsklinikum Hamburg-Eppendorf; Region Västerbotten

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; medulloblastoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Behavior; Medulloblastoma; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: MOVE pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small feasibility study and will not generate data that will be meaningful to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No