Recruiting

RISE

Sponsor:

Emory University

Code:

NCT06799481

Conditions

Cancer-related Cognitive Dysfunction

Primary Brain Neoplasm

Eligibility Criteria

Sex: All

Age: 15 - 39

Healthy Volunteers: Not accepted

Interventions

Aerobic Exercise

Behavioral Intervention

Follow-Up

Internet-Based Intervention

Medical Device Usage and Evaluation

Study Details

Brief 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.

Conditions

Cancer-related Cognitive Dysfunction

Primary Brain Neoplasm

Study ID

NCT06799481

Start date

Feb 13, 2025

Status verified date

Jan, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Aerobic Exercise

Participate in personalized, progressive aerobic training

Behavioral Intervention

Receive active lifestyle behavior coaching

Follow-Up

Receive calls from the trainer

Internet-Based Intervention

Receive access to Physitrack

Medical Device Usage and Evaluation

Wear a Fitbit monitor

Questionnaire Administration

Ancillary studies

Resistance Training

Participating in strength training exercises

Primary outcome measure

  • Enrollment [ Time Frame: Up to 1.5 years ]
  • Adherence to research intervention of virtually supervised exercise program (RISE) [ Time Frame: Up to 12 weeks ]
  • Retention [ Time Frame: Up to 12 weeks ]
  • Acceptability [ Time Frame: Up to 18 weeks ]
  • Change in physical activity levels [ Time Frame: Baseline up to 18 weeks ]
  • Change in cancer-related cognitive impairment [ Time Frame: Baseline up to 18 weeks ]

Central Contacts and Locations

Central contacts

Jinbing Bai, PhD, RN

404-727-2466jinbing.bai@emory.edu

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Emily Bush, BS

emily.bush@emoryhealthcare.org

Principal Investigator:

Jinbing Bai, PhD, RN

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Keri Schadler, PhD

713-794-1035klschadl@mdanderson.org

Maria Chang Swartz

mchang1@mdanderson.org

Principal Investigator:

Keri Schadler, PhD

More Information

Sponsor

Emory University

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-09.