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NCT Number: NCT06799481

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

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.

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Key information

Conditions

Cancer-related Cognitive Dysfunction Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Primary Brain Neoplasm

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital, Atlanta, Georgia, United States

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About this study

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of conducting a two-site pilot randomized controlled trial (RCT) to test the RISE in AYA brain tumor survivors.

II. Examine the impact of RISE on CRCI (primary) and physical activity (secondary).

EXPLORATORY OBJECTIVE:

I. Explore the impact of RISE on the gut microbiome diversity and composition.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (RISE INTERVENTION): 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.

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.

After completion of study intervention, patients are followed up at week 18.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

Participate in personalized, progressive aerobic training

Other names: Aerobic Activity

behavioral intervention

Behavioral

Receive active lifestyle behavior coaching

Other names: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Follow-Up

Procedure

Receive calls from the trainer

Other names: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup

Internet-Based Intervention

Other

Receive access to Physitrack

Medical Device Usage and Evaluation

Other

Wear a Fitbit monitor

Questionnaire Administration

Other

Ancillary studies

Resistance training

Other

Participating in strength training exercises

Other names: Strength Training

Primary outcomes

  1. Enrollment

    Time frame: Up to 1.5 years

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

  2. Adherence to research intervention of virtually supervised exercise program (RISE)

    Time frame: Up to 12 weeks

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

  3. Retention

    Time frame: Up to 12 weeks

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

  4. Acceptability

    Time frame: Up 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.

  5. Change in physical activity levels

    Time frame: Baseline 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.

  6. Change in cancer-related cognitive impairment

    Time frame: Baseline 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.

Secondary outcomes

  1. Gut microbiome

    Time frame: Up to 18 weeks

    Fecal specimens will be collected for the gut microbiome. 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.

  2. Physical function

    Time frame: At baseline and at 12 and 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.

  3. Patient Quality of Life

    Time frame: At baseline and at 12 and 18 weeks

    Will be assessed by Patient Reported Outcomes Measurement Information System-29 recommended. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinbing Bai, PhD, RN

CONTACT

[email protected]

404-727-2466

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • NRG Oncology
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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