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Official Title

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
Timeline
Feb 2025 → Jul 2027
About This Study

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 Criteria

Inclusion Criteria

  • 1Age 15-39 years
  • 2With primary brain tumor with cranial radiotherapy
  • 36 months to 4 years post cranial radiotherapy
  • 4Functional Assessment of Cancer Therapy (FACT)-Cognitive Function score \< 60 based on self-report (used among AYAs with non-neural cancer)
  • 5Able to provide informed consent/assent
  • 6Able to walk and receive clearance from a provider to participate based on the Physical Activity Readiness Questionnaire
  • 7Currently engaging in \< 150 minutes of physical activity per week
  • 8Willing to use smartphone-based applications (app)

Exclusion Criteria

  • 1Secondary malignancies, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
  • 2Moderate to severe traumatic brain injury with brain damage beyond that expected from brain tumor and treatment
  • 3Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders

Locations

1 site participating in this study

Emory University Hospital

Atlanta, Georgia 30322

Recruiting

Jinbing Bai, PhD, RN

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →