Virtual exercise program to help brain tumor survivors with cognitive issues
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
NA · Emory University · NCT06799481
This study is testing a virtual exercise program to see if it can help brain tumor survivors improve their thinking skills and get more active.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 15 Years to 39 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06799481 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the RISE intervention, a virtually supervised exercise program designed to improve cancer-related cognitive impairment (CRCI) and physical activity levels in adolescent and young adult brain tumor survivors. Participants will be randomized into two groups: one receiving the RISE intervention, which includes personalized aerobic and strength training, and the other receiving attention control with weekly check-ins. The study also aims to explore the impact of exercise on the gut microbiome diversity and composition. The trial will assess feasibility and measure outcomes related to cognitive function and physical activity over a 12-week period.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults aged 15-39 who are 6 months to 4 years post cranial radiotherapy for a primary brain tumor and currently engage in less than 150 minutes of physical activity per week.
Not a fit: Patients with secondary malignancies, severe traumatic brain injuries, or major psychotic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance cognitive function and overall quality of life for young brain tumor survivors.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions for cognitive function in cancer survivors, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 this trial is running
Atlanta, Georgia and 1 other locations
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Jinbing Bai, PhD, RN — Emory University
- Study coordinator: Jinbing Bai, PhD, RN
- Email: jinbing.bai@emory.edu
- Phone: 404-727-2466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm