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Virtual Exercise Program (RISE) for Brain Tumor Survivors

This study is looking at how a virtual home-based exercise program, called RISE, might help adolescent and young adult (AYA) brain tumor survivors who are experiencing cancer-related cognitive impairment (CRCI). CRCI can cause problems with thinking, like attention and memory, and can affect daily life. The study will also explore how RISE affects physical activity and the collection of microorganisms in your intestines (gut microbiome). You might be able to join if you are 15-39 years old, had a primary brain tumor with radiation therapy 6 months to 4 years ago, and have reported cognitive issues. The study aims to see if this exercise program is practical and if it can improve cognitive function. There are 60 planned participants, but the current recruitment status is unclear.

Study design
This study is an interventional trial that will involve 60 participants. You will be randomly assigned to either the RISE exercise program or an attention control group.
What's involved
If in the RISE group, you will participate in personalized aerobic and strength training for 12 weeks, along with lifestyle coaching. If in the control group, you will receive weekly calls from a trainer and wear a Fitbit for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
After completing the 12-week intervention, participants will have a follow-up at week 18.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06799481

Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors

Recruiting
NAAges 15–39InterventionalSupportive care
Emory University
~60 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:Aerobic ExerciseBehavioral InterventionFollow-UpInternet-Based InterventionMedical Device Usage and EvaluationQuestionnaire Administration

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Enrollment
Measured over Up to 1.5 years
+5 more outcomes measured

Conditions

Cancer-related Cognitive Dysfunction
Primary Brain Neoplasm

Explore related trials

Brain NeoplasmCancer-related Cognitive Dysfunction

Where it's being run

2 sites across 2 states
Georgia1
Texas1

Study leadership

  • Jinbing Bai, PhD, RN · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Jinbing Bai, PhD, RN
[email protected]
404-727-2466
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • EnrollmentUp to 1.5 years

    Feasibility will be ≥ 50% enrollment of eligible survivors. Descriptive statistics (e.g., frequency and percentage) will be used.

  • Adherence to research intervention of virtually supervised exercise program (RISE)Up to 12 weeks

    Feasibility will be ≥ 75% adherence to RISE. Descriptive statistics (e.g., frequency and percentage) will be used.

  • RetentionUp to 12 weeks

    Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used.

  • AcceptabilityUp to 18 weeks

    Will use an 11-item acceptability questionnaire. A ≥ 4 ("agree" to "strongly agree") per item equates to acceptability. Descriptive statistics (e.g., frequency and percentage) will be used.

  • Change in physical activity levelsBaseline up to 18 weeks

    Will be measured by Fitbit. Physical activity estimates considered as valid if the monitor is worn ≥ 10 hours/day on ≥ 4 days. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.

  • Change in cancer-related cognitive impairmentBaseline up to 18 weeks

    Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.