Medulloblastoma Online Video-based Exercise Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Medulloblastoma, Childhood. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Medulloblastoma Online Video-based Exercise Pilot Study (MOVE)
Overview
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.
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).
Interventions
- 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.
Primary outcome measures
- 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.]
Secondary outcome measures (9)
- Handgrip strength [Time frame: Change from baseline, until 3 and 12 months.]
- Physical activity [Time frame: Change from baseline, until 1.5, 3, 6, and 12 months.]
- Patient-reported quality of life [Time frame: Change from baseline, until 3 and 12 months.]
- Motor function [Time frame: Change from baseline, until 3 and 12 months.]
- Cardiorespiratory fitness [Time frame: Change from baseline, until 3 and 12 months.]
- Epigenetic age acceleration [Time frame: Change from baseline, until 3 and 12 months.]
- Feasibility of the outcome measures [Time frame: 12 weeks]
- Cognitive function [Time frame: Change from baseline to 12 weeks and 12 months.]
- Lower limb strength [Time frame: Change from baseline until 3 and 12 months.]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- Technical University Munich — München
Sweden · 1 center
- Queen Silvia C hildren´s Hospital — Gothenburg
Identifiers
NCT: NCT06898684 · MOVE pilot