Medulloblastoma Online Video-based Exercise Pilot Study
ConditionMedulloblastoma, Childhood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorAron Onerup
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Exercise
BehavioralModerate-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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: ExerciseExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of exercise at 12 weeks and then for prolonged support for another 12 weeks.Secondary outcomes
1
Handgrip strength
Measured with a hand dynamometer
Time frame
Change from baseline, until 3 and 12 months.2
Physical activity
Activity counts per day, registered with accelerometry (Fibion Sens)
Time frame
Change from baseline, until 1.5, 3, 6, and 12 months.3
Patient-reported quality of life
Measured with Patient-Reported Outcomes Measurement Information System (PROMIS)-25.
Time frame
Change from baseline, until 3 and 12 months.4
Motor function
Assessed with the brief ataxia rating scale (BARS), higher numbers indicate worse outcomes.
Time frame
Change from baseline, until 3 and 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aron Onerup
Lead sponsor
Vastra Gotaland Region
Sponsor institution
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
Source ClinicalTrials.gov