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临床试验/NCT05839743
NCT05839743已完成不适用

Investigation of the Effects of Aerobic Exercise, Balance Exercise and Combined Exercise Practices on Frailty, Balance, Fall Risk, Reaction Time, Cognitive Functions and Quality of Life in Dementia Patients

Yuksek Ihtisas University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Muscle Strength Assessment for Sarcopenia

研究概览

简要总结

Dementia is a clinical disorder characterized by progressive and permanent loss of multiple cognitive functions, especially memory, at a level that affects activities of daily living. There is no pharmacologic treatment method that can change the prognosis in dementia. The methods used today are symptomatic and cause various side effects. For this reason, non-pharmacologic approaches are on the agenda in the treatment of dementia. Among these approaches, physical activity approaches such as symptomatic treatment or exercise come to the forefront due to their prognosis-slowing effects. There are also many studies showing that dementia is directly related to physical performance and frailty. Deterioration of physical performance, increased frailty, and decreased muscle strength create a vicious circle with the prognosis of dementia. In addition, patients with dementia have balance problems due to prolonged reaction time, cognitive impairment and physical problems, and the risk of falls increases. In order to prevent the risk of falls, exercise practices are of great importance. Although the effects of aerobic exercise on dementia have been examined many times in the literature, there are very few studies examining the effects of balance exercises and combined exercises. In addition, physical characteristics such as frailty and muscle weakness, which are very common in patients with dementia, have not been evaluated as a whole in studies on patients with dementia. Therefore, this study will be conducted to comparatively examine the effects of combined aerobic exercise and balance exercises on balance and falls, frailty, muscle strength, cognitive functions, and reaction time in patients with dementia.

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
None

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 65 years,
  • To be able to speak and understand Turkish,
  • To have at least primary education,
  • Perceive and adapt to simple commands,
  • Scoring between 18-23 on the standardized mini mental state assessment scale (200),
  • To be able to provide independent mobilization,
  • Volunteering to participate.

排除标准

  • Rapid progression of dementia (infectious, vascular, hematologic diseases),
  • Cardiac or cerebrovascular event, endocrine disorder, fluid-electrolyte imbalance or infection during the follow-up period,
  • Presence of malignancy,
  • Detection of a delirium picture,
  • Presence of severe depression,
  • Participate in a regular exercise program for at least 6 months before the study,
  • Having a fracture or fracture surgery in the lower extremity within the last year,
  • Any orthopedic problem that prevents him/her from exercising.

结局指标

主要结局

Muscle Strength Assessment for Sarcopenia

时间窗: Change from Baseline Muscle Strength Assessment for Sarcopenia at 6 weeks

Muscle strength measurement in kg with a dynamometer

Single Leg Stance Test

时间窗: Change from Baseline Single Leg Stance Test at 6 weeks

If unable to stand for 5 seconds or less client at greater risk of injury from fall.

Functional Reach Test

时间窗: Change from Baseline Functional Reach Test at 6 weeks

10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal.

30 Seconds Sit To Stand Test

时间窗: Change from Baseline 30 Seconds Sit To Stand Test at 6 weeks

For testing leg strength and endurance in older adults. The score is the total number of stands within 30 seconds.

Reaction Time Test

时间窗: Change from Baseline at 6 weeks

The 3 reaction times recorded in milliseconds are averaged.

Wechsler Memory Scale

时间窗: Change from Baseline Wechsler Memory Scale at 6 weeks

Scored on 1-19 Scaled Score Metric. High scores (13 and above) indicate better than expected performance on the dependent variable given performance on the control variable. Low scores (7 and below) indicate poorer than expected performance on the dependent score given performance on the control score. Scores in the average range (8-12) indicate no difference in performance between the control and dependent measures.

Edmonton Frailty Scale

时间窗: Change from Baseline Edmonton Frailty Scale at 6 weeks

0 - 5 = Not Frail, 6 - 7 = Vulnerable, 8 - 9 = Mild Frailty, 10-11 = Moderate Frailty, 12-17 = Severe Frailty

Mental Rotation Test

时间窗: Change from Baseline Mental Rotation Test at 6 weeks

Contains 20 pairs of items worth 1 point each. A high score indicates good mental rotation skill.

Tinetti Balance and Gait Assessment

时间窗: Change from Baseline Tinetti Balance and Gait Assessment at 6 weeks

The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.

Dynamic Gait Index

时间窗: Change from Baseline Dynamic Gait Index at 6 weeks

Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the Dynamic Gait Index is a 24.

Johns Hopkins Fall Risk Assessment Tool

时间窗: Change from Baseline Johns Hopkins Fall Risk Assessment Tool at 6 weeks

6-13 Total Points = Moderate Fall Risk, \>13 Total Points = High Fall Risk

Geriatric Depression Scale

时间窗: Change from Baseline Geriatric Depression Scale at 6 weeks

There are 15 questions. Each question is worth 1 point. A score of 5 or more suggests depression.

Mini Mental State Examination

时间窗: Change from Baseline Reaction Time Test at 6 weeks

The maximum score for the Mini Mental State Examination is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.

The World Health Organization Quality of Life - Old Module

时间窗: Change from Baseline The World Health Organization Quality of Life - Old Module at 6 weeks

It is scored in the range of 4-20. The higher the score, the better the quality of life.

Spatial Orientation Test

时间窗: Change from Baseline Spatial Orientation Test at 6 weeks

Contains 20 pairs of items worth 1 point each. A high score indicates good spatial orientation skill.

次要结局

未报告次要终点

研究者

发起方
Yuksek Ihtisas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilkem Guzel

Lecturer

Yuksek Ihtisas University

研究点 (2)

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