Aerobic Exercise for Brain Tumor Survivors

(Fit ABCS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Donald Mabbott, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Hospital for Sick Children

Disqualifiers: Neurodevelopmental disorder, Palliative care, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial will test if a community-led exercise program using an online system is practical for children who have survived brain tumors. The kids will join group exercise sessions to help improve their fitness by keeping their heart rates up.

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 data supports the effectiveness of the treatment Web-based Aerobic Exercise Program for brain tumor survivors?

Research shows that exercise can improve physical function and mental health in brain cancer survivors, with studies indicating benefits like better fitness, reduced depression, and improved quality of life. Exercise programs have been well-tolerated and beneficial in other cancer populations, suggesting they could be helpful for brain tumor survivors too. ^{1 2 3 4 5}

Is aerobic exercise safe for brain tumor survivors?

Research shows that aerobic exercise programs, including those supervised and web-based, are generally safe for brain tumor survivors, with no reported adverse effects in studies involving both children and adults. ^{1 3 5 6 7}

How is the Web-based Aerobic Exercise Program unique for brain tumor survivors?

This treatment is unique because it offers a web-based, community-led aerobic exercise program specifically designed for brain tumor survivors, focusing on improving physical function and mental health, which are often neglected in traditional treatments. ^{1 2 3 5 8}

Research Team

Donald Mabbott, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Web-based Aerobic Exercise Program (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University

Findings from Research

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]

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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise training improves physical function and fitness in long-term paediatric brain tumour survivors treated with cranial irradiation. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Randomized trial of exercise and an online recovery tool to improve rehabilitation outcomes of cancer survivors. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic exercise interventions in pediatric survivors of brain cancer and other solid tumors: A scoping review. [2023]

6. United States 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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Evaluation of an Outdoor Exercise Program for Pediatric Cancer Survivors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. [2023]