Enhancing Cognitive and Cardiovascular Function in Breast Cancer Survivors Through High-intensity Interval Training
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Adherence to the exercise programs
研究概览
简要总结
This pilot study tests the feasibility and preliminary efficacy of an 8-week, 3-arm pilot exercise trial in which 45 breast cancer survivors will be randomized to high-intensity interval training (HIIT; n=15), moderate-intensity aerobic training (MOD; n=15), or Usual Care (UC; n=15).
详细描述
Aim 1: Determine the feasibility and acceptability of an 8-week high-intensity interval training (HIIT) program compared with a standard moderate-intensity aerobic training (MOD) program in 45 breast cancer survivors prescribed aromatase inhibitors.
Aim 2: Calculate effect sizes associated with the 8-week HIIT program, compared with MOD and Usual Care (UC), on cognitive and cardiovascular functions in 45 breast cancer survivors.
Eligible individuals will be women diagnosed with Stages I-IIIa breast cancer, have completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy), and currently prescribed an aromatase inhibitor. The specific aims are: 1) Determine the feasibility and acceptability of an 8-week high-intensity interval training (HIIT) program compared with a standard moderate-intensity (MOD) program; and 2) Calculate effect sizes associated with the 8-week HIIT program, compared with MOD and usual care (UC), on cognitive and cardiovascular functions. Cognitive function is operationalized as performance on executive function and working memory tasks. Cardiovascular function is operationalized as exercise capacity (VO2peak, heart rate recovery), resting function (heart rate, blood pressure), and cardiovascular structure/function (arterial stiffness, arterial wall thickness, endothelial function). Associations between change in cardiovascular outcomes and change in cognitive outcomes across the intervention period will also be explored.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female (aged 19 or older)
- •First, primary diagnosis of Stage I-IIIa breast cancer
- •Hormone receptor positive (ER+ and/or PR+) diagnosis
- •Human epidermal growth factor receptor 2 negative (HER2-) diagnosis
- •Completed primary adjuvant treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
- •Currently prescribed an aromatase inhibitor
- •No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive Status (TICS-M; score >21)
- •Sedentary except for casual lifestyle recreation. This is defined as self-reporting 20+ minutes of exercise physical activity on 2 or fewer days per week within the previous six months.
- •Receive physician's clearance to participate in an exercise program
- •Agree to be randomized
- •Fully vaccinated for COVID-19 ≥2 weeks prior to participation
- •Provide written informed consent to participate in study
排除标准
- •Stage 0 breast cancer diagnosis or metastatic disease
- •Currently receiving chemotherapy or radiation therapy for any cancer
- •Scheduled to receive breast surgery (e.g., mastectomy, reconstructive surgery) during the study period
- •Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
- •Self-report an 20+ minutes of exercise physical activity on 3+ days per week for the previous 6 months
- •Pregnant or plan to become pregnant during study period.
- •Is not cleared to participate in exercise by a physician.
- •Enrolled in another physical activity program
- •Unable to cycle on a stationary bike
- •Unwilling to complete study requirements
- •History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
- •Clinically significant TICS-M score (<21) during baseline procedures
- •Not fully vaccinated for COVID-19
结局指标
主要结局
Adherence to the exercise programs
时间窗: post-intervention (Week 9)
average number of exercise sessions (out of 24) attended
Compliance of the exercise programs
时间窗: post-intervention
average number of exercise sessions (out of 24) in which the prescribed exercise duration and intensity are achieved
Participation Rate
时间窗: Baseline
Sample size / \[1-(#ineligible/# exposed to recruitment)\*(#exposed to recruitment)\]
Acceptability of the exercise programs
时间窗: post-intervention
satisfaction with the exercise program as measured by a satisfaction survey. Survey uses a 5-point Likert-type scale. Satisfaction for each item is defined as reporting 4-5 on the scale (i.e., somewhat agree or completely agree).
Change in executive function processing
时间窗: Baseline, post-intervention (Week 9)
Change in completion time on Trails B task, with higher values indicating lower executive function.
Change in cognitive flexibility
时间窗: Baseline, post-intervention (Week 9)
Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility
Change in spatial working memory reaction time
时间窗: Baseline, post-intervention (Week 9)
Change in reaction time on spatial working memory task, with faster reaction times indicating better spatial working memory
次要结局
- Change in Cardiorespiratory Fitness(Baseline, post-intervention (Week 9))
- Carotid arterial wall thickness(Baseline, post-intervention (Week 9))
- Endothelial function(Baseline, post-intervention (Week 9))