CompletedNot Applicable

Fitness to Aid the Brain and Cognitive Skills

Canada26 participantsStarted 2021-10-07

Plain-language 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.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Between 6 years and 17 years and 11 months of age at time of enrollment
. Diagnosed with a brain tumour
. 1 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 24 Months

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

Timeframe: 24 weeks

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

Timeframe: 24 weeks

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

Timeframe: 24 weeks

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

Timeframe: 24 weeks

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

Timeframe: 24 weeks

Trial details

NCT IDNCT05367076

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-11

View on ClinicalTrials.gov More Pediatric Brain Tumor trials

Plain-language summary

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Between 6 years and 17 years and 11 months of age at time of enrollment
. Diagnosed with a brain tumour
. 1 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

What they're measuring

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

Timeframe: 24 Months

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

Timeframe: 24 weeks

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

Timeframe: 24 weeks

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

Timeframe: 24 weeks

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

Timeframe: 24 weeks

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

Timeframe: 24 weeks

Fitness to Aid the Brain and Cognitive Skills

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Fitness to Aid the Brain and Cognitive Skills

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria