Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 试验地点
- 2
- 主要终点
- Effects of interventions on cognition
研究概览
简要总结
The purpose of this study is to determine the effects of a coordinated intervention of cognitive remediation training (CRT) and walking intervention on cognition and gait in the elderly.
详细描述
This is a single blind randomized study designed to understand the effects of different interventions, walking interventions and cognitive remediation in particular, towards cognition and gait in the elderly. The study uses a 4 arm approach consisting of 4 intervention groups, with each intervention lasting for 12 weeks. The investigators will investigate the effect of each intervention towards cognitive function and gait. All interventions will be conducted on site at the Pennington Biomedical Research Center, and will be focused on determining the effects of different combinations of walking, cognitive remediation, healthy living courses, and reading. Cognitive measures will include objective clinical measures related to dementia, and the gait analysis will include in clinic and "free living" measures related to falls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women meeting all criteria listed below will be included in the study:
- •Subjects between 65-85 years of age inclusive
- •Subjects with Short Physical Performance Battery of 10 or greater
- •Subjects averaging less than 5,000 steps per day
- •Subjects with Mini Mental State Exam 25-28, inclusive
- •Subjects with normal for age physical-neurological exam
- •Subjects able to walk a city block without a walking aid
- •Written Informed Consent obtained PRIOR to performing any study procedures
排除标准
- •Subjects with difficult walking due to pain or posture
- •Subjects with difficulty in using computer due to significant visual and/or fine motor impairment
- •Subjects with large weight loss (>15 Kilogram) in the last 12 months
- •Subjects with geriatric depression scale >
- •Subjects with Malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled
- •Subjects with abnormal electrocardiogram results. These include: a resting heart rate below 40 bpm or above 100 bpm, previously unknown and/or untreated atrial fibrillation or flutter, evidence of a third degree A-V block, a previously undocumented left bundle branch block, S-T segment depression of greater than 2 mm, evidence of a previous MI, or any other findings that in the clinical judgment of the medical investigator preclude participation in an exercise intervention.
- •Subjects with shortness of breath, exertional angina, uncontrolled high blood pressure or any other chronic medical condition deemed by the physician to preclude participation in an exercise intervention.
- •Subjects with any other medical condition or disease that is life-threatening or that can interfere with, or be aggravated by, exercise.
- •Subjects who currently smoke.
结局指标
主要结局
Effects of interventions on cognition
时间窗: 6 months
Standard psychometric tests will be used to measure cognition
次要结局
- Effects of interventions on gait(6 months)