Can Exercise Improve Cancer Associated Cognitive Dysfunction?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Stroop Test
研究概览
简要总结
Following chemotherapy, some breast cancer survivors report alterations in their ability to remember, concentrate, or think, which can have significant emotional, psychological, and economic impact on their lives. Survivors have also reported feeling frustrated by the response of the medical community, who either may not acknowledge their symptoms or have no treatment options to suggest. Exercise may be a promising treatment, as improvements in cognitive function with exercise have been demonstrated in older adults and other clinical populations.
The investigators will recruit women who have completed chemotherapy for breast cancer (within the past 2 years) and report cognitive changes. Women will be randomly assigned to either a 24-week aerobic exercise intervention or delayed exercise control (offered the same exercise program following the study). At the start and end of the study the investigators will measure: i) performance on four standard neuropsychological tests that measure working memory, learning, and problem solving; ii) a questionnaire on cognitive function and its impact on quality of life; iii) functional magnetic resonance imaging (fMRI) during two of the standard neuropsychological tests which provides information on how the brain is working during the tests.
To knowledge of the investigators this is the first study to examine the effect of an exercise intervention on cognitive function in breast cancer survivors. In addition, the use of fMRI imaging is a new way to approach this research question, and may be more sensitive to change than traditional measures of cognitive function.
详细描述
Objective 1:
Conduct a randomized trial to test the effectiveness of a 24-week aerobic exercise intervention in adult, female breast cancer survivors with self-reported cognitive changes following chemotherapy.
The investigators will test the following hypotheses:
- A) The exercise intervention will improve performance on neuropsychological tests of specific cognitive domains of executive function, namely i)selective attention and response inhibition, ii)processing speed and mental flexibility, and iii) verbal memory and learning in exercisers (EX; n=15) versus delayed exercise controls (CON; n=15).
B) The exercise intervention will reduce self-reported cognitive dysfunction and its impact of function and quality of life, in EX compared to CON, measured as a decreased score on the Functional Assessment Cancer Therapy-Cognition Scale (FACT-Cog).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Completed chemotherapy within past 2 years
- •completed for at least 3 months
- •Self report cognitive dysfunction following chemotherapy
- •Stage I-IIIA breast cancer
- •Physically able to undertake moderate to vigorous physical activity program
排除标准
- •Self report > 90min/week of moderate physical activity (last 6 months)
- •Mini-mental status exam score < 23
- •Co-morbid conditions that may alter cognitive testing results (i.e., a clinically diagnosed major depression, anxiety disorder, or other psychiatric condition, meeting DSM IV criteria)
- •History of substance abuse
- •Other neurological disorder (i.e., head injury, epilepsy, tumour, neurodegenerative disease)
- •Ruled ineligible for MRI scanning (i.e., metal implants)
结局指标
主要结局
Stroop Test
时间窗: Change from baseline at 6 months
Tests response inhibition, measure number of correct vs incorrect responses
次要结局
- Graded exercise test(Change from baseline at 6 months)
- Hopkins Verbal Learning Test(Change from baseline at 6 months)
- FACT-Cog(Change from baseline at 6 months)
- fMRI analyses(Change from baseline at 6 months)
- Trail Making A & B(Change from baseline at 6 months)