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临床试验/NCT03811314
NCT03811314已完成不适用

The Therapeutic Effect of Exercise Training on Old Patients With Dementia and Mild Cognitive Impairment: A Randomized Controlled Trial

Taichung Veterans General Hospital2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2018年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
2
主要终点
Geriatric Depression Scale

研究概览

简要总结

This study aimed to clarify whether strength training or aerobic training could bring more benefits for patients with dementia, another study is to clarify whether isokinetic or isotonic training could bring more benefits for patients with mild cognitive impairment

详细描述

Exercise training has been evidenced to bring various of benefits for patients with dementia in past studies. However, whether strength training or aerobic training could bring better benefits has not been confirmed in the past. This study designed to recruit 30 patients with mild dementia in the first year. Every patient will receive strength training using dumbbells, butterfly machine and vertical leg press machine for four weeks. Outcome measures including self care ability, cognitive function, MCP-1, BDNF and IGF-1 levels, and the degree of depression will be recorded before and after the training. In the second year, the investigators also designed to recruit 31 patients with mild dementia. These participants will instead receive aerobic training using stationary bicycle for four weeks. The same outcome measures will be tested as in the first year. The other part of the study recruited 46 patients with mild cognitive impairment, who were randomized into either a four-week isokinetic or isotonic training program. All cases were evaluated by isokinetic peak torque, 36-item Short Form Survey (SF-36), Mini-Mental State Examination (MMSE), Barthel Index, geriatric depression scale (GDS-15), and Timed Up and Go test (TUG test) before and after each kind of training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Geriatric Depression Scale

时间窗: 4 weeks

To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome

SF-36

时间窗: 4 weeks

consists of 36 questions categorized into 8 subdomains, including physical functioning, role limitations due to physical health, pain, general health condition, vitality, social functioning, role limitations due to emotional problems, and emotional well-being.

Mini-mental state examination

时间窗: 4 weeks

To evaluate cognitive function, range from 0-30, higher values represent a better outcome

Montreal Cognitive Assessment

时间窗: 4 weeks

To evaluate cognitive function, range from 0-30, higher values represent a better outcome

Barthel index

时间窗: 4 weeks

To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome

Timed up and go test

时间窗: 4 weeks

Measure the time taken by a patient to stand up from a chair, walk three meters, return, and sit back on the chair

次要结局

  • Concentration of serum brain derived neurotrophic factor (BDNF)(4 weeks)
  • Concentration of plasma insulin-like growth factor-1 (IGF-1)(4 weeks)
  • Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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