Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)
研究概览
简要总结
The goal of this clinical trial is to investigate the possibility of rehabilitation of mild cognitive deficits in people with metabolic syndrome. We aim to implement a cognitive training program on patients with metabolic syndrome and cognitive deficits, and examine its effectiveness both post-intervention (3 months) and after 12 months.
Researchers will compare two groups, the experimental group that will receive the computerized cognitive training and the control group that will receive no training.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Presence of metabolic syndrome according to the criteria of IDF (2005) or revised NCEP-ATP III (2005)
- •Presence of mild cognitive deficit (-1.5 SD below age and education-adjusted normative mean) in previously administered neuropsychological tests of Trail Making test (Part A & B), Verbal Fluency test (animals and letter "x"), Logical Memory test (immediate and delayed recall)
- •Written informed consent to participate
排除标准
- •Presence of any serious neurological or psychiatric condition
研究组 & 干预措施
Computerized cognitive program
25 participants with metabolic syndrome and mild cognitive deficits; receive health advice using the World Health Organization's guidelines for Risk Reduction of Cognitive Decline and Dementia, and perform the computerized cognitive training program (BrainHQ) for 45 minutes per session, twice per week, over the 3-month intervention period.
干预措施: Computerized cognitive program (Other)
Control group
25 participants with metabolic syndrome and mild cognitive deficits; receive health advice using the World Health Organization's guidelines for Risk Reduction of Cognitive Decline and Dementia.
结局指标
主要结局
Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
HVLT-R assesses verbal memory using a list of words; range 0-36 (immediate recall) and range 0-12 (delayed recall), higher scores represent better cognitive function
Change in scores of the Montreal Cognitive Assessment (MoCA) test
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
MoCA is a screening test for mild cognitive dysfunction; range 0-30, higher scores represent better cognitive function
Change in scores of Complex Figure tests
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
Complex Figures assess visuo-constructional ability and visual memory; range 0-36, higher scores represent better cognitive function
Change in scores of Continuous Performance Test (CPT)
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
CPT assesses executive function and inhibition; range 0-100, higher scores represent better cognitive function
Change in scores of Digit Span test
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
Digit Span assesses working memory; range 0-14 (performance) and range 2-9 (span) for forward and backward condition, higher scores represent better cognitive function
Change in scores of semantic Verbal Fluency test
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
Verbal Fluency assesses executive function that also relies on language component; higher scores represent better cognitive function
Change in scores of Flanker task
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
Flanker task assesses executive function and inhibition; range 0-48, higher scores represent better cognitive function
Change in scores of Set Shifting
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
Set Shifting assesses executive function and set-shifting; range 0-104, higher scores represent better cognitive function
Change in scores of N-back
时间窗: baseline, post-intervention (3 months), follow-up (1 year from baseline)
N-back assesses working memory; range 0-30, higher scores represent better cognitive function
次要结局
- Change in scores of Everyday Cognition-II (Ecog-II)(baseline, follow-up (1 year from baseline))
研究者
Myrto Koutsonida
PhD candidate
University of Ioannina