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Aerobic Exercise for Brain Tumor Survivors (Fit ABCS Trial)

N/A
Recruiting
Led By Donald J Mabbott
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with a brain tumour
Medically stable (i.e. must be in remission) as determined by a permanent SickKids staff Neuro-Oncologist
Must not have
Require sedation for neuroimaging
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial will study whether it is possible to give brain tumor survivors 12 weeks of aerobic exercise training led by their community, and whether a web-based platform can be used to deliver this training.

Who is the study for?
This trial is for children aged 6 to under 18 who have had a brain tumor, are in remission, and can understand English. They must be at least one year post-diagnosis but not more than fifteen years. A parent or guardian must agree to participate in health assessments. Kids with certain conditions, metal implants, recent cognitive therapy, or those pregnant cannot join.Check my eligibility
What is being tested?
The study tests if a web-based aerobic exercise program led by community instructors is doable for young brain tumor survivors over 12 weeks. It aims to see if this online platform works well for delivering the training.See study design
What are the potential side effects?
Since this trial involves an exercise program rather than medication, side effects may include typical physical activity-related issues such as muscle soreness or fatigue. However, specific side effects will depend on each child's condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a brain tumor.
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My condition is stable as confirmed by a SickKids staff Neuro-Oncologist.
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I am between 6 and 17 years old.
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English is my first language or I've studied it for two years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need medicine to help me stay calm for brain scans.
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I was diagnosed with a brain-related condition before my brain tumor that makes participation unsafe.
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I am receiving care to manage cancer symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Interventional procedure
+5 more
Other outcome measures
Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in cardiovascular fitness (heart rate, and sub-maximal and maximal work rates)
Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in controlled attention
Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in declarative memory
+16 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: FitABCS exerciseExperimental Treatment1 Intervention
Web-based community-led, 12-week exercise program

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain tumors include surgery, radiation therapy, chemotherapy, and exercise interventions. Surgery aims to remove the tumor, reducing symptoms and mass effect. Radiation therapy targets and destroys residual cancer cells post-surgery. Chemotherapy uses drugs to kill or inhibit cancer cell growth, often reaching the brain through the blood-brain barrier. Exercise interventions, such as community-led aerobic exercise training, enhance cardiovascular health, reduce fatigue, and improve cognitive function. These treatments are vital for brain tumor patients as they address both the tumor's direct impact and the overall health, aiming to improve survival and quality of life.
Effects of Exercise on Cancer Treatment Efficacy: A Systematic Review of Preclinical and Clinical Studies.Exercise for people with cancer: a systematic review.Motor performance in children and adolescents with cancer at the end of acute treatment phase.

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
692 Previous Clinical Trials
6,946,713 Total Patients Enrolled
Donald J MabbottPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Web-based Aerobic Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT05367076 — N/A
~2 spots leftby Oct 2024
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