RecruitingNot ApplicableNCT06799481

Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors

Virtually Delivered Home-Based Exercise Intervention on Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors: A Pilot Randomized Controlled Trial


Sponsor

Emory University

Enrollment

60 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment (CRCI), physical activity in adolescent and young adult (AYA) brain tumor survivors. This clinical trial also evaluates the impact of RISE on the collection of microorganisms that exist in the intestines (gut microbiome). Up to 45% of AYA brain tumor survivors experience CRCI, including issues with attention and memory. CRCI can have a negative impact on education, independent living and can worsen long-term quality of life. Moderate-intensity levels of exercise, particularly aerobic and resistance training, have been shown to improve cognitive function. Additionally, exercise can change the composition and function of the gut microbiome, which may lead to improved cognitive function. Unfortunately, only about 50% of AYAs with cancer receive exercise information or meet the physical activity recommendations. Tailoring a virtually delivered exercise intervention to meet the unique needs of AYAs may improve access to exercise. Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may also help researchers understand the relationship of exercise on the gut microbiome and cognitive function.


Eligibility

Min Age: 15 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study tests a virtual, home-based exercise program called RISE for adolescents and young adults (ages 15-39) who have survived a brain tumor and received radiation to the brain. Many brain tumor survivors experience thinking and memory problems (cancer-related cognitive impairment) after treatment, and the study also looks at whether exercise affects the gut microbiome. **You may be eligible if...** - You are between 15 and 39 years old - You had a primary brain tumor and received cranial (brain) radiation therapy - It has been between 6 months and 4 years since your brain radiation - You report problems with thinking or memory (cognitive function score below 60) - You are currently getting less than 150 minutes of physical activity per week - You can walk and a healthcare provider has cleared you for exercise - You are willing to use a smartphone app **You may NOT be eligible if...** - Your cancer has come back and you need re-irradiation of the brain - You have a moderate to severe traumatic brain injury beyond what was caused by the tumor - You have a secondary cancer or a genetic syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAerobic Exercise

Participate in personalized, progressive aerobic training

BEHAVIORALBehavioral Intervention

Receive active lifestyle behavior coaching

PROCEDUREFollow-Up

Receive calls from the trainer

OTHERInternet-Based Intervention

Receive access to Physitrack

OTHERMedical Device Usage and Evaluation

Wear a Fitbit monitor

OTHERQuestionnaire Administration

Ancillary studies

OTHERResistance Training

Participating in strength training exercises


Locations(2)

Emory University Hospital

Atlanta, Georgia, United States

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06799481


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