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NCT Number: NCT06898684

Medulloblastoma Online Video-based Exercise Pilot Study

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.

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Key information

Conditions

Medulloblastoma, Childhood Behavior Glioma Medulloblastoma Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technical University Munich, München, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the remote assessment and a digitally delivered exercise intervention

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

    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.

Secondary outcomes

  1. Handgrip strength

    Time frame: Change from baseline, until 3 and 12 months.

    Measured with a hand dynamometer

  2. Physical activity

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

    Activity counts per day, registered with accelerometry (Fibion Sens)

  3. Patient-reported quality of life

    Time frame: Change from baseline, until 3 and 12 months.

    Measured with Patient-Reported Outcomes Measurement Information System (PROMIS)-25.

  4. Motor function

    Time frame: Change from baseline, until 3 and 12 months.

    Assessed with the brief ataxia rating scale (BARS), higher numbers indicate worse outcomes.

  5. Cardiorespiratory fitness

    Time frame: Change from baseline, until 3 and 12 months.

    Assessed with the 3-min step in place test

  6. Epigenetic age acceleration

    Time frame: Change from baseline, until 3 and 12 months.

    Epigenetic age will be determined from DNA methylation analyses of DNA extracted from saliva samples.

  7. Feasibility of the outcome measures

    Time frame: 12 weeks

    The researchers will develop the outcome assessments battery by removing outcome assessments that are not feasible through video.

  8. Cognitive function

    Time frame: Change from baseline to 12 weeks and 12 months.

    Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function 7a.

  9. Lower limb strength

    Time frame: Change from baseline until 3 and 12 months.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aron Onerup, MD, PhD

CONTACT

[email protected]

+46766185619

Sponsors and collaborators

Lead sponsor

Aron Onerup

Other Gov

Collaborators

  • Göteborg University
  • Region Skane
  • Region Stockholm
  • Region Västerbotten
  • Region Östergötland
  • Technical University of Munich
  • Universitätsklinikum Hamburg-Eppendorf
  • Uppsala University

Registry information

Official study title

Medulloblastoma Online Video-based Exercise Pilot Study (MOVE)

Acronym: MOVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 27, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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