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临床试验/NCT04021888
NCT04021888Unknown不适用

The Effects of Exercise Program in Alzheimer's Patients With Mild to Moderate Stage Alzheimer's Disease

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Change in cognition

研究概览

简要总结

The primary aim of this trial is to investigate the feasibility of an exercise program consisting of respiratory exercises, aerobic exercises and strengthening exercises in mild to moderate Alzheimer's disease. The trial also aims to investigate the effectiveness of the exercise program on respiratory symptoms, exercise capacity, cognition, physical performance, depression, sleepiness, activities of daily living and quality of life.

Patients will be divided into exercise (intervention) and control group by randomization method. The study is planned to be performed with a total of 60 patients, 30 in each group. The patients in the exercise group will be given breathing exercises aerobic exercises and strengthening exercises for 2 days a week for 12 weeks, about 30-40 minutes while the patients in the control group will be provided with suggestions, home exercise program and daily life activities

详细描述

Exercise group was trained 3 times a week under the supervision of a physiotherapist and encouraged to exercise at home on other days

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
Single (Outcomes Assessor)

盲法说明

An assessor who was blinded to treatment groups assessed clinical outcomes before the treatment process. The same assessor was also repeated assessments at 13th week (at the end of treatment process)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged over 65 years
  • can walk independent

排除标准

  • can't see
  • have done any exercise in the last 6 months
  • have a major and uncontrolled orthopedic, neurological or cardiopulmonary problem that restricts functioning
  • having non Alzheimer's disease dementia

研究组 & 干预措施

Exercise Group

Experimental

干预措施: Exercise (Other)

Control

Active Comparator

干预措施: Exercise (Other)

结局指标

主要结局

Change in cognition

时间窗: Baseline, 12th week

The Mini-Mental State Examination (MMSE) is used to measure cognitive impairment in older adults. It assesses different subset of cognitive status including attention, language, memory, orientation, visuospatial proficiency.

次要结局

  • Change in pulmonary functions(Baseline, 12th week)
  • Change in respiratory muscle strength(Baseline, 12th week)
  • Change in functional capacity(Baseline, 12th week)
  • Change in physical performance(Baseline, 12th week)
  • Change in sleepiness(Baseline, 12th week)
  • Change in quality of life(Baseline, 12th week)
  • Change in activities of daily living(Baseline, 12th week)
  • Change in depression(Baseline, 12th week)
  • Change in muscle strength(Baseline, 12th week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elvan Keles

Research Assistant

Dokuz Eylul University

研究点 (2)

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