Medulloblastoma Online Video-based Exercise Pilot Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (2)