跳至主要内容
临床试验/NCT01553929
NCT01553929终止不适用

Physical Trainig and Cognitive Activity on the MCI Patient

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
effectiveness of physical training

研究概览

简要总结

Regular physical activity is now recognized as a key element of good physical and mental health and this all ages.

MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive training in improving the cognitive function of patients diagnosed with Mild Cognitive Impairment (MCI).

DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for the patient with three groups : one physical training and cognitive exercise group, one physical training without cognitive exercise group and one control group.

In agreement with the literature on the effects of physiological stress on cognitive performance, the investigators expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire. Furthermore the investigators hypothesize that this positive effect is greater in the physical training and cognitive exercise group compared with the physical training group only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed patient MCI (Mild Cognitive Impairment)
  • Elderly from 40 to 75 years old
  • MMSE upper to 22
  • Affiliated or beneficiary of a national insurance scheme
  • Medical capacity to the physical proposed activity (filling of the conditions of the Medical certificate of not contraindication in the sport)

排除标准

  • The placed persons under guardianship, under protection of justice,
  • The private persons of freedom (administrative or judicial)
  • Nobody already participating in a clinical trial

结局指标

主要结局

effectiveness of physical training

时间窗: up to 3 months

Assess the effectiveness of physical training associated with a cognitive training in improving the cognitive functions of patients diagnosed with Mild Cognitive Impairment (MCI). We expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire.

次要结局

  • Cognitive improvement(up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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