Aerobic Exercise for Brain Tumor Survivors

(Fit ABCS Trial)

Overseen By Cynthia de Medeiros, M.Sc.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Neurodevelopmental disorder, Palliative care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 38

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a community-led, web-based aerobic exercise program is practical and beneficial for children and teens who have survived brain tumors. Participants will engage in a 12-week exercise program to determine its feasibility in improving health and quality of life. The trial will also explore the effectiveness of delivering this program online. Children and teens diagnosed with a brain tumor, currently in remission, and medically stable may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the well-being of young brain tumor survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for paediatric brain tumour survivors?

Research shows that aerobic exercise can be safe and beneficial, even for children who have survived brain tumors. Studies have found that exercise programs can enhance physical health without major safety concerns. Online platforms have successfully delivered these programs, helping participants stay active and healthy.

Aerobic exercise programs, like the one in this trial, typically include activities that increase the heart rate, such as running or cycling. Most participants manage these activities well, with few reports of serious health issues, indicating that most people can perform these exercises without major problems.

Using an online platform for exercise is a relatively new concept, especially for young cancer survivors. However, early studies have demonstrated that online exercise guidance is practical and safe. Participants can follow exercise routines at home, offering convenience and flexibility while maintaining safety.

Overall, while this type of exercise program is new for this group, research suggests it is likely safe and well-tolerated. The main goal is to ensure that children can exercise regularly and safely, potentially improving their overall health and recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for brain tumor survivors that often emphasize medication and surgery, the web-based aerobic exercise program offers a unique, non-invasive approach to improving patient outcomes. This program is community-led and accessible online, making it easier for participants to engage in regular physical activity from the comfort of their homes. Researchers are excited about this trial because they hope to discover whether consistent aerobic exercise can enhance cognitive function and overall quality of life for survivors, offering a complementary strategy to existing medical treatments.

What evidence suggests that this web-based aerobic exercise program is effective for paediatric brain tumour survivors?

Studies have shown that exercise can positively impact brain function and overall health in children who have survived brain tumors. Research indicates that aerobic exercise, like that in the web-based exercise program tested in this trial, can enhance thinking and learning skills in these survivors. Evidence supports that structured exercise programs are safe and feasible for children who have had brain cancer. Early findings suggest these programs can improve thinking skills and quality of life. This makes the online aerobic exercise program a promising option for pediatric brain tumor survivors seeking to boost mental and physical well-being. Participants in this trial will join either the web-based exercise program or a control group for comparison. ^{1 2 3 4 6}

Who Is on the Research Team?

Donald Mabbott, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with a brain tumor.

My condition is stable as confirmed by a SickKids staff Neuro-Oncologist.

I am between 6 and 17 years old.

Exclusion Criteria

Have a programmable shunt

I haven't had any brain training therapy in the last 3 months.

I need medicine to help me stay calm for brain scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of community-led aerobic exercise training, involving 90-minute group sessions 3 times per week.

12 weeks

36 sessions (in-person)

Follow-up

Participants are monitored for changes in physical functioning, brain structure, and cognitive outcomes at 3-month follow-up.

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Web-based Aerobic Exercise Program

Trial Overview 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.

How Is the Trial Designed?

Group I: FitABCS exercise Experimental Treatment 1 Intervention

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

Group II: FitABCS control Active Control 1 Intervention

Healthy control

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

The study is evaluating a tailored exercise intervention for childhood cancer survivors with exercise intolerance, involving 160 participants randomized into intervention and control groups over a 20-week period.

The intervention includes a personalized exercise plan delivered via telehealth, aiming to improve physical activity levels and overall health without the need for travel, which may enhance adherence and confidence in exercising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance. Maharaj, A., Jefferies, JL., Mulrooney, DA., et al.[2023]

A 12-week structured exercise program was well tolerated by two female brain cancer patients, with no adverse effects reported, indicating that exercise can be safely integrated into their treatment plans.

Both participants showed significant improvements in physical strength, cardiovascular fitness, and psychological well-being, including reduced anxiety and depression, suggesting that exercise may enhance quality of life for brain cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. Levin, GT., Greenwood, KM., Singh, F., et al.[2018]

Cancer survivors prefer exercise programs supervised by specialists who understand cancer, and they value support from healthcare providers and accessible community locations, as identified in a study with 13 survivors and 5 caregivers before the ACE trial.

After participating in the ACE trial, survivors expressed a need for better exercise counseling from healthcare providers and suggested that exercise should be introduced earlier in their care, highlighting gaps in support that could improve their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study. Suderman, K., Dolgoy, N., Yurick, J., et al.[2021]

Cancer survivors participating in a 12-week exercise program combined with the Restwise online recovery program showed significant improvements in aerobic capacity and muscle strength, outperforming those in the exercise-only group.

While both groups improved, the exercise plus Restwise group had notably greater enhancements in the 6-minute walk (18.5% more), leg press (35.2% more), and chest press (45% more), indicating that the Restwise program may enhance recovery outcomes for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of exercise and an online recovery tool to improve rehabilitation outcomes of cancer survivors. Schwartz, AL., Biddle-Newberry, M., de Heer, HD.[2018]

A controlled clinical trial involving 28 children who survived brain tumors showed that exercise training significantly improved physical functioning, particularly in bilateral coordination, with benefits lasting up to 12 weeks after training ended.

Participants in group training settings also experienced increased cardiopulmonary fitness, as indicated by improved work rates, highlighting the effectiveness of structured exercise programs for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training improves physical function and fitness in long-term paediatric brain tumour survivors treated with cranial irradiation. Piscione, PJ., Bouffet, E., Timmons, B., et al.[2018]

A scoping review of 17 studies involving pediatric survivors of brain cancer and other solid tumors found that therapeutic exercise interventions are feasible and safe, with no reported adverse events.

The studies indicated that exercise programs led to improvements in cardiorespiratory fitness, functional strength, physical activity levels, and overall quality of life for participants aged 7.3 to 15.5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic exercise interventions in pediatric survivors of brain cancer and other solid tumors: A scoping review. Kohler, BE., Sandler, CX., Baque, E., et al.[2023]

A regional outdoor exercise program for pediatric cancer survivors showed high participation and enthusiasm, with 26 survivors engaging in various activities over one year and no adverse events reported during 302 hours of physical activity.

The main motivation for participation was the opportunity to try new sports, while a significant barrier was the fear of not being able to keep up with peers, indicating the need for supportive environments to boost confidence in continuing exercise independently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Evaluation of an Outdoor Exercise Program for Pediatric Cancer Survivors. Blosch, C., Krombholz, A., Beller, R., et al.[2022]

A submaximal exercise program for glioma patients, consisting of individualized sessions of bicycle ergometry and resistance training, was found to be safe and feasible, with only two minor epileptic events reported during 1828 training sessions.

Patients participating in the program achieved significant cardiorespiratory fitness, with a median survival of 24.1 months for glioblastoma patients, suggesting that exercise may positively impact their overall health and longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. Jost, J., Müther, M., Brandt, R., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05367076

NCT05367076 | Fitness to Aid the Brain and Cognitive Skills The study will assess the feasibility of a pilot clinical trial of community-led aerobic exercise training for paediatric brain tumour survivors (PBTS) and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11387797/

A web-based resource for exercise training in children ... Both manuals discuss paediatric brain tumours and the benefits of physical activity on cognition in survivors. The eHealth resources are described in Table 1.

3. withpower.com withpower.com/trial/phase-pediatric-brain-tumors-9-2021-be4c3

Aerobic Exercise for Brain Tumor Survivors (Fit ABCS Trial) This trial will test if a community-led exercise program using an online system is practical for children who have survived brain tumors.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05367076?tab=history&a=4

Record History | ver. 4: 2024-01-24 | NCT05367076 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).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9535626/

Therapeutic exercise interventions in pediatric survivors of ... The extant literature supports the feasibility and safety of therapeutic exercise interventions for pediatric survivors of brain cancer and other solid tumors.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772696725000092

Implementing an online-delivered exercise program for ... This is the first study to investigate the implementation and delivery of an online exercise program to childhood cancer survivors in conjunction with a ...