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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 39
Healthy Volunteers: f
View:

• 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)

Locations
United States
Georgia
Emory University Hospital
RECRUITING
Atlanta
Contact Information
Primary
Jinbing Bai, PhD, RN
jinbing.bai@emory.edu
404-727-2466
Time Frame
Start Date: 2025-02-13
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Arm I (RISE)
Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.
Active_comparator: Arm II (attention control)
Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.
Related Therapeutic Areas
Sponsors
Collaborators: NRG Oncology, National Cancer Institute (NCI)
Leads: Emory University

This content was sourced from clinicaltrials.gov