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临床试验/CTRI/2025/10/096618
CTRI/2025/10/096618尚未招募不适用

Effects of a Community-Based Structured Group Exercise Program on Cognitive and Physical Function among Older Adults with Dementia: A COGEX-D Randomized Controlled Trial

Al Amin1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Cognitive function by

研究概览

简要总结

The COGEX-D Randomized Controlled Trial aims to assess the effects of a 12-week community-based structured group exercise program on cognitive and physical function among older adults with dementia. The study includes community-dwelling adults aged 60 years or older who have a clinically confirmed dementia diagnosis according to DSM criteria and an MMSE score between 10 and 24. Participants must also be able to sit on a chair and walk 10 feet independently. Those with severe neurological, psychiatric, cardiorespiratory, or musculoskeletal conditions that prevent safe participation in exercise, along with individuals with a history of cancer, major surgery, severe sensory impairments, or substance abuse, will be excluded. The trial features two groups: an experimental group and a control group. The experimental group will receive a 12-week intervention combining lifestyle education—focusing on diet, hydration, sleep, and healthy aging—with a structured group exercise program. This exercise regimen will include aerobic walking, strength training, stretching, and breathing exercises, with sessions occurring three times per week and led by a trained physiotherapist. The control group will follow the same lifestyle education but will not engage in the exercise program. Adherence to the program will be monitored, and cognitive and physical function will be assessed at baseline, 12 weeks, and 24 weeks using various tests, including the MMSE, Addenbrooke’s Cognitive Examination-Revised, Senior Fitness Test, Berg Balance Scale, and the Timed Up and Go Test. The study will enroll 120 participants, with a total duration of 8 months, and the outcomes will provide valuable insight into the potential benefits of structured exercise on both cognitive and physical function in older adults with dementia.

研究设计

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

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Participants will be included if: (1) they are community dwelling males and females aged 60 years or older, (2) they have a clinically confirmed diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM), (3) they have a Mini-Mental State Examination (MMSE) score between 10 and 24 (exclusive), (4) they are able to sit on a chair and walk 10 feet (3.05 metres) without physical assistance, (5) they consent to participate in the intervention and assessments of this study.

排除标准

  • Participants will be excluded if: (1) they have any neurological disorders, severe psychiatric conditions, uncontrolled arterial hypertension, or severe cardiorespiratory or musculoskeletal problems that prevent safe participation in exercise, (2) they have been diagnosed with cancer or have undergone major surgery in the past year, (3) they have severe vision or hearing impairments that interfere with communication or assessment, (4) they have a history of alcohol or drug abuse.

结局指标

主要结局

Cognitive function by

时间窗: Baseline, 12 weeks and 24 weeks

Mini-Mental State Examination, Addenbrooke’s Cognitive Examination Revised, Trail Making Test A–B, Digit Span test

时间窗: Baseline, 12 weeks and 24 weeks

次要结局

  • Physical function by(Senior Fitness Test, Berg Balance Scale, Timed Up and Go (TUG) Test, Instrumental Activities of Daily Living Scale)

研究者

发起方
Al Amin
申办方类型
Other [self-funded]
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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