Pediatric Brain TumorFit ABCSNCT05367076
Fitness to Aid the Brain and Cognitive Skills
A study testing Web-based Aerobic Exercise Program in people with Pediatric Brain Tumor and Cognitive Impairment, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Brain Tumor, Cognitive Impairment
- What is being tested?
- Web-based Aerobic Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 7 Oct 2021to 11 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Web-based Exercise Training Program for Brain Repair and Cognitive Recovery for Paediatric Brain Tumour Survivors in the Community: a Feasibility Study
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.
Read the detailed description
PBTS will complete 12 consecutive weeks of exercise training. Exercise training will involve 90-minute group sessions of aerobic activity 3 times/week with a 30-minute snack/reward time. The investigators anticipate participants will complete the exercise training program in cohorts, each comprised of a minimum of 3 and maximum of 10 participants. With a minimum of 3 participants per cohort, in order for us to achieve the investigators' goal of recruiting 30 participants, the investigators anticipate running approximately 7 cohorts. Participants will be assigned to a cohort based on proximity to session location and availability to attend sessions.
Site Description:
This is a single-site trial, as participants will be recruited from SickKids. Community-led exercise training will be delivered at various locations across the Greater Toronto and Hamilton Area (GTHA). Exercise training sessions will be conducted in partnership with Wellspring, a network of community support services across the GTHA for individuals diagnosed and treated for cancer. The investigators have developed a web-based platform for Fitness Trainers/Therapists (FTTs) to i) educate them on working with PBTS, ii) build exercise session plans, and iii) provide feedback on sessions and overall web-based platform functionality and usability. The web-based platform will allow the administration of community-led exercise training in any location. To test the feasibility of the web-based platform, the investigators will be administering exercise training in approximately 5 locations associated with Wellspring centres (and/or surrounding gymnasiums or outdoor space) and Wellspring FTTs.
Study Intervention Description:
Exercise training will consist of group sessions of aerobic exercise. Each session will include five (5) components:
- Warm-up activities
- Aerobic training activities
- Group sports/games
- Cool-down activities
- Snack/reward time The goal of the intervention is to increase and maintain participants' heart rate for at least 30 minutes per session at a minimum of 80% of participants' peak heart rate achieved during a baseline fitness assessment. Increased heart rate will mainly take place during the aerobic circuit training and group sport/game components of each session. Heart rate will be measured using heart rate monitors.
Description of study population:
- Sample size: n = 40 (30 PBTS, 10 Healthy Controls)
- Age: 6-17 years
- Sex: males and females
- General health [PBTS]: Patients who have completed treatment for hemispheric or posterior fossa tumours and do not have severe neurological/motor dysfunction that would preclude safe participation in an exercise program
- General health [Healthy Controls]: Do not have neurological/motor dysfunction that would preclude safe participation in baseline assessment or have a prior history of neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability at time of enrollment
- Geographic location: Canada
- Conditions
- Pediatric Brain Tumor, Cognitive Impairment
- Being tested
- Web-based Aerobic Exercise Program
- Keywords
- Exercise, Physical functioning
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Aerobic Exercise ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| FitABCS exercise | Experimental | Web-based community-led, 12-week exercise program Receives: Behavioral: Web-based Aerobic Exercise Program |
| FitABCS control | No intervention | Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start7 Oct 2021
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Mabbott, The Hospital for Sick Children
- Investigators
- Donald J Mabbott, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367076
- Sponsor's protocol ID
- 1000073462
- Acronym
- Fit ABCS
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Web-based Exercise Training Program for Brain Repair and Cognitive Recovery for Paediatric Brain Tumour Survivors in the Community: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05367076
- Acronym / sponsor ID
- Fit ABCS / 1000073462
- Conditions
- Pediatric Brain Tumor, Cognitive Impairment
- Keywords
- Exercise, Physical functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PBTS will complete 12 consecutive weeks of exercise training. Exercise training will involve 90-minute group sessions of aerobic activity 3 times/week with a 30-minute snack/reward time. The investigators anticipate participants will complete the exercise training program in cohorts, each comprised of a minimum of 3 and maximum of 10 participants. With a minimum of 3 participants per cohort, in order for us to achieve the investigators' goal of recruiting 30 participants, the investigators anticipate running approximately 7 cohorts. Participants will be assigned to a cohort based on proximity to session location and availability to attend sessions.
Site Description:
This is a single-site trial, as participants will be recruited from SickKids. Community-led exercise training will be delivered at various locations across the Greater Toronto and Hamilton Area (GTHA). Exercise training sessions will be conducted in partnership with Wellspring, a network of community support services across the GTHA for individuals diagnosed and treated for cancer. The investigators have developed a web-based platform for Fitness Trainers/Therapists (FTTs) to i) educate them on working with PBTS, ii) build exercise session plans, and iii) provide feedback on sessions and overall web-based platform functionality and usability. The web-based platform will allow the administration of community-led exercise training in any location. To test the feasibility of the web-based platform, the investigators will be administering exercise training in approximately 5 locations associated with Wellspring centres (and/or surrounding gymnasiums or outdoor space) and Wellspring FTTs.
Study Intervention Description:
Exercise training will consist of group sessions of aerobic exercise. Each session will include five (5) components:
- Warm-up activities
- Aerobic training activities
- Group sports/games
- Cool-down activities
- Snack/reward time The goal of the intervention is to increase and maintain participants' heart rate for at least 30 minutes per session at a minimum of 80% of participants' peak heart rate achieved during a baseline fitness assessment. Increased heart rate will mainly take place during the aerobic circuit training and group sport/game components of each session. Heart rate will be measured using heart rate monitors.
Description of study population:
- Sample size: n = 40 (30 PBTS, 10 Healthy Controls)
- Age: 6-17 years
- Sex: males and females
- General health [PBTS]: Patients who have completed treatment for hemispheric or posterior fossa tumours and do not have severe neurological/motor dysfunction that would preclude safe participation in an exercise program
- General health [Healthy Controls]: Do not have neurological/motor dysfunction that would preclude safe participation in baseline assessment or have a prior history of neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability at time of enrollment
- Geographic location: Canada
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FitABCS exercise | Experimental | Behavioral: Web-based Aerobic Exercise ProgramWeb-based community-led, 12-week exercise program |
| FitABCS control | No intervention | –Healthy control |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Aerobic Exercise ProgramCommunity 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 | Behavioural | FitABCS exercise |
Primary outcome
Feasibility of the exercise program: The probability that 30 eligible patients will be recruited
Time frame: 24 Months
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
Feasibility of the exercise program: The probability that a recruited participant will attend ≥60% of exercise training sessions
Time frame: 24 weeks
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.
Feasibility of the exercise program: The probability that a recruited participant will complete all study procedures
Time frame: 24 weeks
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
Feasibility of the exercise program: The probability that instructors will adhere to the web-based platform to deliver exercise training
Time frame: 24 weeks
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
Feasibility of the exercise program: The probability that instructors will develop a therapeutic alliance with the participants
Time frame: 24 weeks
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.
Feasibility of the web-based platform: The probability that instructors will rate the platform as acceptable
Time frame: 24 weeks
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
Feasibility of the web-based platform: The probability that instructors will rate the platform as relevant
Time frame: 24 weeks
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
Feasibility of the web-based platform: The probability that instructors will rate the platform as efficient
Time frame: 24 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald J Mabbott principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based Aerobic Exercise Program in people with Pediatric Brain Tumor and Cognitive Impairment, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the exercise program: The probability that 30 eligible patients will be recruited (time frame: 24 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.