NCT01944761

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2015

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

4.1 years

First QC Date

August 15, 2013

Last Update Submit

July 11, 2025

Conditions

Keywords

PediatricsBrain TumorNeuro-radiationExercise

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

EXPERIMENTAL

The 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).

Behavioral: Exercise Program

Delayed Exercise Training

EXPERIMENTAL

The 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).

Behavioral: Exercise Program

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.

Delayed Exercise TrainingExercise Training

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

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: 29876282BACKGROUND
  • Piscione 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: 28551430BACKGROUND
  • Riggs 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: 27555603BACKGROUND
  • Cox 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: 32403066BACKGROUND
  • Baudou 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.

MeSH Terms

Conditions

Brain NeoplasmsMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Donald Mabbott, PhD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

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

Locations