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临床试验/CTRI/2025/07/090849
CTRI/2025/07/090849Not Applicable不适用

Effects of Structural exercise on Community dwelling older adults with Dementia

Dr Ehsanur Rahman1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月26日最近更新:

试验速览

阶段
不适用
状态
Not Applicable
发起方
入组人数
120
试验地点
1
主要终点
1.Dementia Diagnosed by Mini-Mental State Examination (MMSE)

研究概览

简要总结

This randomized controlled trial aims to evaluate the effects of a 12-week structured exercise program on physical and cognitive function in community-dwelling older adults with dementia. Participants will be randomly assigned to either an exercise group receiving strengthening, stretching, and mobility training, or a lifestyle modification group receiving health education and non-physical cognitive/social activities. Primary outcomes include balance, physical function, and daily living ability (MMSE, GDS, FRSSD, SF-36, and Likert Scale -sociodemographic). Secondary outcomes include Physical function (include handgrip test, TUG, BBS, and Chair-Stand Test at baseline, 3 and 6 months).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • Community-dwelling older adults aged 60 years or above; MMSE score of 10 or more; clinically diagnosed dementia with dependence in at least one personal activity of daily living; able to stand up from a chair with armrests with help from one person or less; approved by physician; able to hear and understand instructions for assessments.

排除标准

  • Participants will be excluded if they suffer from other neurological disease and severe diseases which would not allow participation in exercise (severe psychiatric illnesses, uncontrolled arterial hypertension, severe cardiorespiratory problems, severe musculoskeletal problems), cancer, surgery during the previous year, severe vision and/or hearing problems, or alcohol and/or drug abuse.

结局指标

主要结局

1.Dementia Diagnosed by Mini-Mental State Examination (MMSE)

时间窗: Baseline at 3 months, 6 months

2. Depression by Geriatric Depression Scale (GDS)

时间窗: Baseline at 3 months, 6 months

3.Daily living functionality by Functional Rating Scale for Symptoms of Dementia (FRSSD).

时间窗: Baseline at 3 months, 6 months

4.Quality of life by SF-36 short edition.

时间窗: Baseline at 3 months, 6 months

5.Likert Scale for sociodemographic question

时间窗: Baseline at 3 months, 6 months

次要结局

  • 1. Physical function assessed by using handgrip test, Timed Up to Go (TUG), Berg Balance Scale (BBS) and Chair-Stand Test (CST)(Baseline at 3 months, 6 months)

研究者

发起方
Dr Ehsanur Rahman
申办方类型
Other [university]
责任方
Principal Investigator
主要研究者

Al Amin

Jashore University of Science and Technology

研究点 (1)

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