Fitness to Aid the Brain and Cognitive Skills

NCT05367076 | Completed

• 1 other identifier: 1000073462
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess the feasibility of a pilot clinical trial of community-led aerobic exercise training for paediatric brain tumour survivors (PBTS) and the feasibility of a web-based platform to deliver this exercise training. It is hypothesized that 12 weeks of community-led exercise training will be feasible for PBTS and the web-based platform will be feasible to deliver exercise training by community-based instructors.

Conditions

Pediatric Brain Tumor; Cognitive Impairment

Keywords

Exercise; Physical functioning

Outcome Measures

Primary Outcomes (8)

• Feasibility of the exercise program: The probability that 30 eligible patients will be recruited

  In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory patient recruitment. The goal is to recruit n=30 participants (≥25% probability) Measure: The Bayesian probability statistic that 30 eligible patients will be recruited

  24 Months

• Feasibility of the exercise program: The probability that a recruited participant will attend ≥60% of exercise training sessions

  In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory participant attendance. The goal is for a participant to attend ≥60% of exercise training sessions (≥80% probability of participants). Measure: The Bayesian probability statistic that participants will rate the therapeutic alliance between participant/instructor as cooperative and collaborative.

  24 weeks

• Feasibility of the exercise program: The probability that a recruited participant will complete all study procedures

  In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory participant adherence to study procedures (neuroimaging, cognitive, health and quality of life (QOL), cardiovascular fitness and physical functioning assessments). The goal is for a recruited participant to complete all study procedures (≥80% probability). Measure: The Bayesian probability statistic that a recruited participant will complete all study procedures

  24 weeks

• Feasibility of the exercise program: The probability that instructors will adhere to the web-based platform to deliver exercise training

  In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory instructor adherence to deliver the program. The goal is for instructors to adhere to the web-based platform to deliver exercise training (≥80% probability). Measure: The Bayesian probability statistic that instructors will adhere to the web-based platform to deliver exercise training

  24 weeks

• Feasibility of the exercise program: The probability that instructors will develop a therapeutic alliance with the participants

  In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory rating by the participant of the therapeutic alliance between participants and instructors. The goal is for participants to have a cooperative and collaborative relationship with the instructors, as rated by the Therapeutic Alliance Scales for Children-Revised questionnaire. Measure: The Bayesian probability statistic that the therapeutic alliance between participant/instructor will be comparable across cohorts.

  24 weeks

• Feasibility of the web-based platform: The probability that instructors will rate the platform as acceptable

  In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as acceptable (e.g. would recommend to others, would continue to use). The goal is for instructors to rate the the platform as acceptable, indicating ease of use and satisfaction (≥80% probability). Measure: The Bayesian probability statistic that instructors will rate the platform as acceptable

  24 weeks

• Feasibility of the web-based platform: The probability that instructors will rate the platform as relevant

  In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as relevant (e.g. includes all necessary components to administer an exercise program, would choose to use such a tool to deliver an exercise program).The goal is for the instructors to rate the platform as relevant, indicating the presence of necessary information (≥80% probability). Measure: The Bayesian probability statistic that instructors will rate the platform as relevant

  24 weeks

• Feasibility of the web-based platform: The probability that instructors will rate the platform as efficient

  In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as efficient (e.g. is useful). The goal is for the instructors to rate the platform as efficient, indicating its usefulness (≥80% probability). Measure: The Bayesian probability statistic that instructors will rate the platform as efficient

  24 weeks

Other Outcomes (28)

• Comparison of community-led vs. historical hospital-led exercise training program: Changes in hippocampal volume

  Baseline, Week 13, and Week 25

• Comparison of community-led vs. historical hospital-led exercise training program: Changes in neural communication

  Baseline, Week 13, and Week 25

• Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in information processing speed

  Baseline, Week 13, and Week 25

Study Arms (2)

FitABCS exercise

EXPERIMENTAL

Web-based community-led, 12-week exercise program

Behavioral: Web-based Aerobic Exercise Program

FitABCS control

NO INTERVENTION

Healthy control

Interventions

Web-based Aerobic Exercise Program BEHAVIORAL

Community based FTTs will use a web-based platform to deliver a 12-week exercise training program (120-minute group sessions of aerobic activity 3 times/week). Each session will include: * Warm-up activities * Aerobic activities and fitness training in a game-like fashion * Organized sports/games * Cool down activity * Snack/reward time

FitABCS exercise

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between 6 years and 17 years and 11 months of age at time of enrollment
• Diagnosed with a brain tumour
• to 15 years between diagnosis and time of study enrollment
• Medically stable (i.e. must be in remission) as determined by a permanent SickKids staff Neuro-Oncologist
• Either declare English as their native language or have at least two years of schooling in English at the time of their first assessment
• Have a parent or legal guardian willing to complete the Health and Quality of Life measures
• Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardians

You may not qualify if:

• Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
• Diagnosed with a neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability prior to initial brain tumour diagnosis that would preclude safe participation
• Receiving palliative care
• Require sedation for neuroimaging
• Have ferrous metal implants (i.e. cochlear implant, braces, etc.)
• Have a programmable shunt
• Pregnant
• Completed any prior cognitive rehabilitation intervention within three months of enrollment

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Donald J Mabbott

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist and Program Head

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 10, 2022
• Study Start: October 7, 2021
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)