Study on Physical Activity's Relationship With Cancer and Cognition: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Executive Function
研究概览
简要总结
This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). Participants will be randomized to a 12-week walking intervention or usual care. Walking participants will attend small group sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist. All participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI). The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue.
详细描述
Aim 1: This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). To test aim 1, the investigators will randomize up to forty post-menopausal BCS (3-24 months post-treatment) to a 12-week walking intervention (n=20) or usual care (n=20). Walking participants will attend small group (n=3-5 BCS) sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist after all data have been collected. Aim 1 measures include accelerometry, neurocognitive testing, and patient-reported outcomes at baseline and post-intervention.
Aim 2: The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue. To test aim 2, all participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI).
Data will be analyzed using descriptive statistics and analysis of covariance, and effect sizes expressed as standard mean difference will be calculated.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal at time of diagnosis
- •First, primary diagnosis of Stage I-IIIa breast cancer
- •Completed treatment 3-24 months prior to study start
- •Available to attend exercise sessions 3 times weekly for 12 weeks
- •No scheduled travel >7 consecutive days during the intervention
- •Agree to be randomized
- •Willingness to wear, charge, and sync Fitbit
- •English reading and speaking
- •Physician's clearance to exercise
- •Provide written informed consent
排除标准
- •Pre- or peri-menopausal at the time of diagnosis
- •Stage 0 or metastatic disease
- •Currently receiving chemotherapy or radiation therapy
- •More than 24 months post-treatment
- •Scheduled to receive breast surgery
- •Second cancer diagnosis (excluding non-invasive skin cancers)
- •Self-report an average of ≥60 minutes of moderate to vigorous physical activities (MVPA) per week for the previous 6 months
- •Not cleared to exercise by a physician
- •Not available to attend 3 times weekly exercise sessions for 12 weeks
- •Out of town travel scheduled for >1 week during the intervention
- •Unwilling to complete baseline assessments
- •Unwilling to be randomized to the exercise or control group
- •Unwilling to wear, charge, and sync the Fitbit during the study period
- •Unable to read and speak in English
- •Unwilling to provide written informed consent to participate
- •Cognitive impairment prior to baseline assessment
- •History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
结局指标
主要结局
Change in Executive Function
时间窗: Baseline, Week 12
A comprehensive neurocognitive battery will be administered to measure executive function as defined by a latent factor of manifest indicators of performance on executive function tasks.
Change in Processing Speed
时间窗: Baseline, Week 12
A comprehensive neurocognitive battery will be administered to measure processing speed as defined by a latent factor of manifest indicators of processing speed tasks.
Change in Working Memory
时间窗: Baseline, Week 12
A comprehensive neurocognitive battery will be administered to measure working memory as defined by a latent factor of manifest indicators of performance on working memory tasks.
次要结局
- Resting state functional connectivity(Baseline, Week 12)
- White matter structural integrity(Baseline, Week 12)
- Cancer-related Fatigue(Baseline, Week 12)
- N2pc Amplitude(Baseline, Week 12)
- Cardiorespiratory Fitness(Baseline, Week 12)
- Regional brain volume(Baseline, Week 12)
- Objective Activity Behavior(Baseline, Week 12)