Fitness to Aid the Brain and Cognitive Skills

Titre officiel

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

Sommaire:

L’étude évaluera la faisabilité d’une version pilote d’essai clinique d’un entraînement aérobique communautaire pour les survivants de tumeurs cérébrales pédiatriques (STCP) et la faisabilité d’une plateforme en ligne pour dispenser cet entraînement. L’hypothèse est que 12 semaines d’entraînement communautaire seront réalisables pour les STCP, et que la plateforme Web permettra aux entraîneurs de dispenser l’entraînement à l’échelle communautaire.

Description de l'essai

Primary Outcome:

• Feasibility of the exercise program: The probability 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
• Feasibility of the exercise program: The probability 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
• Feasibility of the web-based platform: The probability that instructors will rate the platform as acceptable
• Feasibility of the web-based platform: The probability that instructors will rate the platform as relevant
• Feasibility of the web-based platform: The probability that instructors will rate the platform as efficient

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 4 and maximum of 10 participants. With a minimum of 4 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

Voir cet essai sur ClinicalTrials.gov