Fitness to Aid the Brain and Cognitive Skills — Fit ABCS  

Cognitive Impairment Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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 = 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 ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Cognitive Impairment
• Pediatric Brain Tumor

• NCT number: NCT05367076
• Study type: Interventional
• Source: The Hospital for Sick Children
• Contact: Donald J Mabbott, Ph.D.
• Phone: 416-813-7654
• Email: donald.mabbott@sickkids.ca
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Completion date: October 6, 2025