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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Aerobic Exercise
  Participate in personalized, progressive aerobic training
• Поведенческое Behavioral Intervention
  Receive active lifestyle behavior coaching
• Процедура Follow-Up
  Receive calls from the trainer
• Другое Internet-Based Intervention
  Receive access to Physitrack
• Другое Medical Device Usage and Evaluation
  Wear a Fitbit monitor
• Другое Questionnaire Administration
  Ancillary studies
• Другое Resistance Training
  Participating in strength training exercises

Первичные конечные точки

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

Вторичные конечные точки (3)

• Gut microbiome [Срок оценки: Up to 18 weeks]
• Physical function [Срок оценки: At baseline and at 12 and 18 weeks]
• Patient Quality of Life [Срок оценки: At baseline and at 12 and 18 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Emory University Hospital — Atlanta
• MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06799481 · STUDY00008229 · NCI-2025-00181 · STUDY00008229 · WINSHIP6364-24 · P30CA138292

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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