Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score
研究概览
简要总结
The purpose of this pilot study will be to test whether Kundalini yoga (KY) and Kirtan Kriya (KK) yogic meditation is superior to Memory Enhancement Training (MET) for improving cognitive functioning, health (including cardiovascular factors), and mood in women with high AD risk.
详细描述
Overall, the investigators anticipate recruiting 100 women (50 or older) with MCI and high Alzheimer's disease risk. Subjects will either receive: (1) MET class for 60 minutes per week; or (2) Kundalini yoga and "Kirtan Kriya" meditation class for 60 minutes per week. Assessments will be completed immediately after the interventions at 6 and 12 weeks and follow-up visits at week 24 and 48 to monitor the overall benefit of the intervention.
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
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Amnestic MCI, as defined by a Clinical Dementia Rating Scale score of .
- •High cardiovascular risk defined as at least one of the following:
- •7.5 percentile risk or higher using ASCVD risk calculator
- •Myocardial Infarction more than 6 months ago
- •Taking medication for blood pressure > 140/90 blood pressure
- •Taking medication for lyperlipidemia LDL >160
- •Sufficient English proficiency and the 8th grade or higher reading level as determined by the word reading subtest of the Wide Range Achievement Test-IV (this criterion is necessary in order to ensure ability to participate in MET, which involves reading and writing and has a Flesch-Kinkaid school equivalency of 7th grade)
- •Capacity to provide informed consent
排除标准
- •History of psychosis, bipolar disorder, alcohol/ drug dependence, or neurological disorder
- •Recent (within three months) surgery, anticipated surgery within next year, or unstable medical condition
- •Any disability preventing participation in MET or KK+KY (e.g., severe visual or hearing impairment)
- •Insufficient English proficiency to participate in either MET or KK+KY
- •Diagnosis of dementia
- •Mini Mental Health Examination score of 23 or below
- •Currently taking any psychoactive medication
- •Participation in a psychotherapy that involves cognitive training
- •Practice of Kundalini Yoga or Kirtan Kriya within the past year
- •Myocardial Infarction within the past 6 months
结局指标
主要结局
Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score
时间窗: Measured at Baseline and Week 24
Verbal memory was measured with the Hopkins Verbal Learning Test (HVLT) total recall scores. The HVLT form contains 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. When scoring the HVLT, the three learning trials are combined to calculate a total recall score. Total scores range from 0-36 with higher scores indicating better outcome.
Change in Delayed Recall Cognitive Domain Scores
时间窗: Measured at Baseline and Week 24
Delayed Recall Cognitive Domain score was constructed from: HVLT Delayed Recall, Rey-Osterrieth Complex Figure Test \[30-minute Delayed Recall\], WMS-IV Logical Memory II Delayed Recall. Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. A z-score of 0 represents the sample mean. These z-scores were then averaged to produce a Delayed Recall Cognitive Domain score. Higher Delayed Recall Cognitive Domain scores are indicative of better performance.
Change in Executive Function Cognitive Domain Scores
时间窗: Measured at Baseline and Week 24
Executive Function Cognitive Domain score was constructed from: Trail Making Test A and B, Stroop Interference \[Golden version\] and FAS. Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. A z-score of 0 represents the sample mean. These z-scores were then averaged to produce an Executive Function Cognitive Domain score. Higher Executive Function Cognitive Domain scores are indicative of better performance.
次要结局
- Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36)(Measured at Baseline and Week 24, change from baseline to week 24 is reported.)
- Change in Memory Functioning Questionnaire (MFQ) Scale(Measured at Baseline and Week 24, change from baseline to week 24 is reported.)
研究者
Helen Lavretsky, MD
Professor
University of California, Los Angeles