Fitness to Aid the Brain and Cognitive Skills

Study Overview
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Brief Summary
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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
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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 = 30 Age: 6-17 years Sex: males and females General health: 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 Geographic location: Canada

Official Title
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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

Conditions
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Pediatric Brain Tumor, Cognitive Impairment

Intervention / Treatment
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* Behavioral: Web-based Aerobic Exercise Program


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FitABCS exercise<br>Web-based community-led, 12-week exercise program | Behavioral: Web-based Aerobic Exercise Program<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical functioning, Exercise