A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)
研究概览
简要总结
To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy
详细描述
Primary Objective:
Determine the feasibility and acceptability of a virtually supervised exercise intervention compared to control in AYAs with brain tumors undergoing cranial radiotherapy (CRT).
Secondary Objective:
Assess the effect of supervised exercise intervention on the neuroanatomic structure and cognitive function changes in AYAs with brain tumors undergoing CRT.
Exploratory Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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 old
- •Self-reported diagnosis of a primary benign or malignant brain tumor or confirmed diagnosis of primary benign or malignant brain tumor radiographically or pathologically when available (relapse or newly diagnosed)
- •Plans to receive CRT at MDACC or, if the participant has already started CRT, the participant is eligible if they are within 3 weeks of the start of CRT
- •Received appropriate physician clearance
- •Able to move arms and legs, and ambulate safely
- •Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week)
- •Participants and/or guardians are willing and able to provide informed consent
- •Has a smartphone with available space to download additional apps
- •Does not have sensorimotor strip impairment as indicated by the clinical team
- •Has internet access
- •Can receive physical therapy because this is part of the standard of care
- •Participants and/or guardians are willing and able to provide informed consent for protocol PA18-0130 (Pediatric Energy Balance Data Repository Study), companion protocol for the Fitbit application/assessment.
排除标准
- •Non-English speaking
- •Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q).12
- •Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
- •Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions
- •Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
- •Self-reported diagnosis of a metastatic brain tumor or confirmed diagnosis of a metastatic brain tumor radiographically or pathologically when available
- •Self-report of pregnancy
- •Currently enrolled in another physical activity or exercise intervention
- •Self-reported pregnancy status
研究组 & 干预措施
Actigraph
A device worn on the waist that measures physical activity (such as the number of steps participants walk each day, how long participants spend standing, and how long partticipants spend laying down). Participants should wear the ActiGraph at least 10 hours a day for 7 days.
干预措施: Standard Fitbit Program (Behavioral)
Actigraph
A device worn on the waist that measures physical activity (such as the number of steps participants walk each day, how long participants spend standing, and how long partticipants spend laying down). Participants should wear the ActiGraph at least 10 hours a day for 7 days.
干预措施: Virtual Exercise Program (Behavioral)
结局指标
主要结局
MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)
时间窗: Through study completion an average of 1 year.
Scale Score ranges from 0-10 0-Symptom has not been present 10-The symptom was as bad as you can imagine it could be
次要结局
未报告次要终点