Combining Exercise and Cognitive Training to Improve Everyday Function
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Cooking Breakfast task
研究概览
简要总结
The purpose of this randomized, controlled, prospective study is to evaluate the benefits of combining aerobic exercise with cognitive training for optimizing cognitive function. The study will enroll 109 men and women, age 55-75 years who are in stable health and without contraindications to exercise or evidence of dementia or cognitive impairment. Individuals will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and Home Exercise and Health Education. Participants will undergo measurements of cognitive function, physical performance, and complete questionaires about daily activities, physical activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 55-75 years (inclusive)
- •English-speaking
- •sufficient visual and auditory perception to complete testing
- •available informant (someone who knows the individual well)
- •Clinical Dementia Rating of 0 (non-demented per the screening assessment).
排除标准
- •participation in a regular exercise program in last 6 months
- •participation in a cognitive training program in last 6 months
- •inability to walk on a treadmill or ride an exercise bike
- •less than a 10th grade education
- •mild cognitive impairment or dementia
- •cigarette smoking within the previous year
- •history of alcohol or substance abuse
- •BMI greater than 35
- •insulin-dependent diabetes
- •major and/or unstable medical, neurological, or psychiatric disorder, including:
- •active congestive heart failure
- •unstable angina
- •effort angina
- •nocturnal angina
- •MI within previous 6 months
- •ECG evidence of serious arrhythmias and/or acute myocardial ischemia reflected by ST-segment depression of 0.3 mm
- •resting blood pressure above 170 systolic or 100 diastolic
- •chronic infections
- •advanced arthritis
- •contractures or weakness due to CVA that would prevent adequate performance of the exercises.
- •disabling stroke
- •late stage renal or liver disease
- •major affective disorder with active symptoms
结局指标
主要结局
Cooking Breakfast task
时间窗: Change in task performance between baseline and 6 months
Participants engage in a computerized laboratory simulation of a cooking task to assesses cognitive dimensions of planning, prospective memory, monitoring the progress of ongoing activity, anticipating potential problems, task switching, and task coordination.
Memory for Medical Information
时间窗: Change in memory task performance between baseline and 6 months
This task measures the ability of the individual to learn and recall complex medical information, and the source of the information.
Virtual Week task
时间窗: Change in task performance between baseline and 6 months
Participants engage a computerized board game that simulates choices about, and recall of, daily and weekly activities.
次要结局
- Peak Aerobic Power(Baseline, Month 6)
- Activities of Daily Living--Yale Physical Activity Scale (YPAS)(Baseline, Month 3, Month 6, Month 12)
- Uniform Data Set (UDS)(Baseline, Month 12)
- Late Life Function & Disability Index (LLFDI)(Baseline, Month 6, Month 12)
- Geriatric Depression Scale(Baseline, Month 12)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, Month 6, Month 12)
- Objective Physical Performance Tests(Baseline, Month 6)
- Prospective and Retrospective Memory Questionnaire (PMRQ)(Baseline, Month 6, Month 12)
- Cognitive assessment battery(Baseline, Month 6, Month 12)