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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06799481
Status
Recruiting
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Conditions

  • Cancer-related Cognitive Dysfunction
  • Primary Brain Neoplasm

Eligibility Criteria

Sex
ALL
Age
15 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Aerobic Exercise — OTHER
    Participate in personalized, progressive aerobic training
  • Behavioral Intervention — BEHAVIORAL
    Receive active lifestyle behavior coaching
  • Follow-Up — PROCEDURE
    Receive calls from the trainer
  • 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

Study Details

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.

Key Dates

Start date
Feb 13, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Enrollment [ Time Frame: Up to 1.5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Emily Bush, BS
[email protected]
Jinbing Bai, PhD, RN (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Keri Schadler, PhD
[email protected]
713-794-1035
Maria Chang Swartz
[email protected]
Keri Schadler, PhD (PRINCIPAL_INVESTIGATOR)

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