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临床试验/NCT02968875
NCT02968875已完成不适用

Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training

University Hospital Center of Martinique2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.

研究概览

简要总结

Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common forms of dementia in humans and memory disorder is one of the first symptoms that lead to diagnosis.

详细描述

Present in greater amounts in the regions of the hippocampus and cortex, the Brain-derived neurotrophic factor (BDNF) is essential to both learning and memory processes. This protein is found in lower amounts in people with AD. Acute physical activity of moderate to vigorous intensity would increase the levels of plasma BDNF whether for a healthy person or a person with AD. Nevertheless in rest, healthy people have higher level of BDNF than individuals with AD. There are no studies on the effect of chronic exercise based on BDNF level at rest in people with AD. In a hypothetical endurance training of 18 sessions, whether interval or continuous training the levels of BDNF would increase in people with AD at rest. Their physiological and neuropsychological performances would also show a rise.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Alzheimer's disease patients diagnosed by a consultation memory (DSM- IV)
  • Person with at least 60 years
  • Person with a score higher than 15 in the Mini Mental State Examination
  • No one can achieve the pedaling motion
  • People who do not perform regular physical activity on bike
  • Nobody has given free and informed consent in writing or obtained from a trusted person or the family environment
  • People affiliated to a social security

排除标准

  • Patient who refused to provide written consent
  • Inability to pedal
  • Recent myocardial necrosis (less than 3 months)
  • Aortic Stenosis
  • Uncompensated heart failure
  • Unstable angina
  • Ventricular arrythmia
  • Pulmonary embolism
  • Coxarthrosis, knee, ankle osteoarthritis
  • Not affiliated to a social security
  • Patient already participating in another biomedical research

研究组 & 干预措施

Endurance Training

Active Comparator

The first group of 40 people will do endurance training; 20 of them will perform a continuous exercise on cycle ergometer at a power equivalent to 70% of the maximal heart rate, twice a week. The other group will do Interval Training, with a four minute long base and one minute long peak, twice a week. The base workload will be equivalent to an intensity of 60% of the maximal heart rate and the peak will be equivalent to 80% of the maximal heart rate.

干预措施: Endurance Training (Device)

Control group

Active Comparator

20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings.

干预措施: therapeutic education meetings (Other)

结局指标

主要结局

Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.

时间窗: Up to 4 months

次要结局

  • Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)(Up to 4 months)
  • Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)(Up to 4 months)
  • Measuring the effect of training on the physiological performance with a walk test of 6 minutes.(Up to 4 months)
  • Measuring the effect of training on the psychological performance by using questionnaire MMSE(Up to 4 months)
  • Stress test(Up to 4 months)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (2)

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