The Neuro-protective Effects of Exercise in Children With Brain Tumors
1 other identifier
interventional
32
1 country
1
Brief Summary
The objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved outcome, particularly recovery of white matter and grey matter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2011
CompletedFirst Submitted
Initial submission to the registry
August 15, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2015
CompletedJuly 16, 2025
July 1, 2025
4.1 years
August 15, 2013
July 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of implementing an excercise intervention
We will look at several factors, including recruitment rate, exercise adherence rate, retention rate and participant/parent satisfaction to determine the feasability of this intervention
At week 42-45
Secondary Outcomes (3)
Fitness
Baseline, once at week 26-29 and once at week 42-45
Neuro-cognitive outcome
Baseline, once at week 26-29 and once at week 42-45
Neural recovery (gliogenesis/neurogenesis)
Baseline, once at week 26-29 and once at week 42-45
Study Arms (2)
Exercise Training
EXPERIMENTALThe 16 participants in this group will be quasi-randomized based on the order of recruitment to start the 12 week exercise intervention without delay (immediate condition).
Delayed Exercise Training
EXPERIMENTALThe 16 participants in this group will be quasi-randomized based on the order of recruitment to start the 12 week exercise intervention after a 12 week no exercise training period (delayed condition).
Interventions
Designed to improve cardio-respiratory fitness, the exercise program will be conducted for 12 weeks at a frequency of 3-4 sessions per week. Each exercise session will be conducted after school for a total duration of 90 minutes (group sessions) or 30 minutes (home-based sessions). Group session activities will include i) warm-up (i.e. walk/jog, games) \[10 mins\], ii) aerobic training/fitness games \[30 mins\], iii) organized sports \[30 mins\], iv) cool down (i.e. stretching, low intensity games) \[10 mins\] and v) snack and reward (15 mins). Participants in the Group setting had three 90-minute group sessions per week. Participants in the Combined setting had two 90-minute group sessions and two 30-minute individual home-based sessions per week.
Eligibility Criteria
You may qualify if:
- Survivors will be included if they are between 7 and 17 years of age.
- Survivors will be included if they either declare English as their native language or have had at least two years of schooling in English at the time of their first assessment.
- Survivors must have been diagnosed with a hemispheric or posterior fossa tumor and been treated with cranial spinal radiation.
- Survivors no more than 10 years may have elapsed between diagnosis and time of study.
- Survivors with a shunt will be included in the study, but will need to be identified prior to study on-set to discuss any specific considerations for imaging and physical activity.
You may not qualify if:
- are younger than 7 years (the delivery of an intervention program to young children carries challenges that make it difficult to include in an initial feasibility grant) or older than 17 years
- require sedation for MRI imaging
- is claustrophobic
- have severe neurological/motor dysfunction that would preclude safe participation in an exercise program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (5)
Szulc-Lerch KU, Timmons BW, Bouffet E, Laughlin S, de Medeiros CB, Skocic J, Lerch JP, Mabbott DJ. Repairing the brain with physical exercise: Cortical thickness and brain volume increases in long-term pediatric brain tumor survivors in response to a structured exercise intervention. Neuroimage Clin. 2018 Mar 5;18:972-985. doi: 10.1016/j.nicl.2018.02.021. eCollection 2018.
PMID: 29876282BACKGROUNDPiscione PJ, Bouffet E, Timmons B, Courneya KS, Tetzlaff D, Schneiderman JE, de Medeiros CB, Bartels U, Mabbott DJ. Exercise training improves physical function and fitness in long-term paediatric brain tumour survivors treated with cranial irradiation. Eur J Cancer. 2017 Jul;80:63-72. doi: 10.1016/j.ejca.2017.04.020. Epub 2017 May 25.
PMID: 28551430BACKGROUNDRiggs L, Piscione J, Laughlin S, Cunningham T, Timmons BW, Courneya KS, Bartels U, Skocic J, de Medeiros C, Liu F, Persadie N, Scheinemann K, Scantlebury N, Szulc KU, Bouffet E, Mabbott DJ. Exercise training for neural recovery in a restricted sample of pediatric brain tumor survivors: a controlled clinical trial with crossover of training versus no training. Neuro Oncol. 2017 Mar 1;19(3):440-450. doi: 10.1093/neuonc/now177.
PMID: 27555603BACKGROUNDCox E, Bells S, Timmons BW, Laughlin S, Bouffet E, de Medeiros C, Beera K, Harasym D, Mabbott DJ. A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors. Clin Neurophysiol. 2020 Jul;131(7):1533-1547. doi: 10.1016/j.clinph.2020.03.027. Epub 2020 Apr 13.
PMID: 32403066BACKGROUNDBaudou E, Ryan JL, Cox E, Nham L, Johnston K, Bouffet E, Bartels U, Timmons B, de Medeiros C, Mabbott DJ. Optimizing an exercise training program in pediatric brain tumour survivors: Does timing postradiotherapy matter? Neurooncol Pract. 2023 Sep 9;11(1):69-81. doi: 10.1093/nop/npad055. eCollection 2024 Feb.
PMID: 38222057DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Mabbott, PhD
The Hospital for Sick Children, Toronto Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Psychologist
Study Record Dates
First Submitted
August 15, 2013
First Posted
September 18, 2013
Study Start
February 3, 2011
Primary Completion
March 16, 2015
Study Completion
March 16, 2015
Last Updated
July 16, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share