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

Recruiting now · Not applicable

Conditions studied: Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm

In brief

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.

Key facts

Study ID: NCT06799481
Run by: Emory University
People needed: 60
Starts: 2025-02-13
Expected to finish: 2027-07-31
Last updated by the study team: 2026-01-09

Who can join

Age: 15 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 15-39 years
With primary brain tumor with cranial radiotherapy
6 months to 4 years post cranial radiotherapy
Functional Assessment of Cancer Therapy (FACT)-Cognitive Function score < 60 based on self-report (used among AYAs with non-neural cancer)
Able to provide informed consent/assent
Able to walk and receive clearance from a provider to participate based on the Physical Activity Readiness Questionnaire
Currently engaging in < 150 minutes of physical activity per week
Willing to use smartphone-based applications (app)

You may not qualify if…

Secondary malignancies, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
Moderate to severe traumatic brain injury with brain damage beyond that expected from brain tumor and treatment
Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders

Where it is running

Emory University Hospital — Atlanta, Georgia, United States (enrolling)
MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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