Fitness to Aid the Brain and Cognitive Skills (NCT05367076) | Clinical Trial Compass
CompletedNot Applicable
Fitness to Aid the Brain and Cognitive Skills
Canada26 participantsStarted 2021-10-07
Plain-language 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.
Who can participate
Age range6 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✕
What they're measuring
1
Feasibility of the exercise program: The probability that 30 eligible patients will be recruited
Timeframe: 24 Months
2
Feasibility of the exercise program: The probability that a recruited participant will attend ≥60% of exercise training sessions
Timeframe: 24 weeks
3
Feasibility of the exercise program: The probability that a recruited participant will complete all study procedures
Timeframe: 24 weeks
4
Feasibility of the exercise program: The probability that instructors will adhere to the web-based platform to deliver exercise training
Timeframe: 24 weeks
5
Feasibility of the exercise program: The probability that instructors will develop a therapeutic alliance with the participants
Timeframe: 24 weeks
6
Feasibility of the web-based platform: The probability that instructors will rate the platform as acceptable
Timeframe: 24 weeks
7
Feasibility of the web-based platform: The probability that instructors will rate the platform as relevant