Fitness to Aid the Brain and Cognitive Skills

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Pediatric Brain Tumor
• Interventions: Behavioral: Web-based Aerobic Exercise Program

• Registration Number: NCT05367076
• Lead Sponsor: The Hospital for Sick Children

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.

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:

1. Warm-up activities

2. Aerobic training activities

3. Group sports/games

4. Cool-down activities

5. 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 Timeline

• Study Start: 2021-10-07
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12-06
• Study Completion: 2026-01-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Between 6 years and 17 years and 11 months of age at time of enrollment
2. Diagnosed with a brain tumour
3. 1 to 15 years between diagnosis and time of study enrollment
4. Medically stable (i.e. must be in remission) as determined by a permanent SickKids staff Neuro-Oncologist
5. Either declare English as their native language or have at least two years of schooling in English at the time of their first assessment
6. Have a parent or legal guardian willing to complete the Health and Quality of Life measures
7. Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardians

Exclusion Criteria

1. 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
2. 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
3. Receiving palliative care
4. Require sedation for neuroimaging
5. Have ferrous metal implants (i.e. cochlear implant, braces, etc.)
6. Have a programmable shunt
7. Pregnant
8. Completed any prior cognitive rehabilitation intervention within three months of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FitABCS exercise	Web-based Aerobic Exercise Program	Web-based community-led, 12-week exercise program

Primary Outcome Measures

Name	Time	Method
Feasibility of the exercise program: The probability that a recruited participant will attend ≥60% of exercise training sessions	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 30 eligible patients will be recruited	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 instructors will develop a therapeutic alliance with the participants	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 exercise program: The probability that a recruited participant will complete all study procedures	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	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 web-based platform: The probability that instructors will rate the platform as acceptable	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	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	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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada