Fitness to Aid the Brain and Cognitive Skills

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05367076
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The Hospital for Sick Children
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Donald J Mabbott
Principal Investigator Affiliation The Hospital for Sick Children
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pediatric Brain Tumor, Cognitive Impairment
Additional Details

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 = 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

Arms & Interventions

Arms

Experimental: FitABCS exercise

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

Interventions

Behavioral: - Web-based Aerobic Exercise Program

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Recruiting

Address

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Site Contact

Donald J Mabbott, Ph.D.

[email protected]

416-813-7654 #308875

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