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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
To maintain blinding, only the exercise trainer and statistician will know group assignments.
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Aerobic Exercise (Other)
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.
干预措施: Behavioral Intervention (Behavioral)
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.
干预措施: Internet-Based Intervention (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Resistance Training (Other)
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.
干预措施: Follow-Up (Procedure)
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.
干预措施: Medical Device Usage and Evaluation (Other)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Enrollment
时间窗: Up 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)
时间窗: Up to 12 weeks
Feasibility will be ≥ 75% adherence to RISE. Descriptive statistics (e.g., frequency and percentage) will be used.
Retention
时间窗: Up to 12 weeks
Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used.
Change in cancer-related cognitive impairment
时间窗: 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.
Acceptability
时间窗: 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.
Change in physical activity levels
时间窗: 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.
次要结局
- Physical function(At baseline and at 12 and 18 weeks)
- Gut microbiome(Up to 18 weeks)
- Patient Quality of Life(At baseline and at 12 and 18 weeks)
研究者
Jinbing Bai
Principal Investigator
Emory University