NCT06799481Recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- Emory University
- Diseases
- Childhood cancers
- NCT number
- NCT06799481
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Feb 2025 to the primary completion date, Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Secondary malignancies, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
- Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders
Other
- Moderate to severe traumatic brain injury with brain damage beyond that expected from brain tumor and treatment
Who the study is looking for
- 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)
Age in the registry: 15 years to 39 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.