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临床试验/NCT05720416
NCT05720416
已完成
不适用

Effects of a Multi-intervention Programme on the Muscle Strength, Body Composition, Physical Performance and Quality of Life of the Elderly

Central Taiwan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 207 人2023年8月22日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Sarcopenia
发起方
Central Taiwan University of Science and Technology
入组人数
207
试验地点
1
主要终点
Chang in Cornell Scale for Depression in Dementia from baseline to 16 weeks
状态
已完成
最后更新
去年

概览

简要总结

  1. To develop a multiactivity training programme. 2. To explore the effect of this programme on sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease. 3. To compare the effects of the experimental and control treatments on the muscle strength, body composition, physical function performance and quality of life of the elderly.
注册库
clinicaltrials.gov
开始日期
2023年8月22日
结束日期
2024年12月31日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Chiu Shu-Ching

assistant professor of nursing department

Central Taiwan University of Science and Technology

入排标准

入选标准

  • (1) over 60 years old, (2) able to Communicate and follow instructions; (3) Stable condition with sufficient physical strength: able to maintain a seated position in a wheelchair or on the edge of a bed for at least one hour. (4) sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease.

排除标准

  • (1) difficulty in standing or walking and obvious musculoskeletal disease, (2) unsuitable for diagnosis by a physician those engaged in sports activities, (3) serious diseases/unstable states, such as severe heart, lung, liver and kidney diseases, severe malignant tumors, severe nutrition poor, severe dementia, (4) more than 180 minutes of exercise per week in the past month, (5) no willingness to participate.

结局指标

主要结局

Chang in Cornell Scale for Depression in Dementia from baseline to 16 weeks

时间窗: Baseline and 16 weeks

Mental Function Assessment. The range for total score is 0-38. A Higher score means a worse outcome.

Chang in muscle strength from baseline to 16 weeks

时间窗: Baseline and 16 weeks

pinch, grip and quadriceps strength. A Higher score means a better outcome.

Chang in Cohen-Mansfield Agitation Inventory from baseline to 16 weeks

时间窗: Baseline and 16 weeks

This is a scale of behavior measurement. The range for total is 29-203. A higher score means a worse outcome.

Chang in EQ5D from baseline to 16 weeks

时间窗: Baseline and 16 weeks

This is a scale of quality of life. The range for total is 0-20. A higher score means a worse outcome.

Chang in QUALIDEM from baseline to 16 weeks

时间窗: Baseline and 16 weeks

The scale is a dementia-specific Qol instrument. The range for total score is 0-120. A higher score means a better outcome.

Chang in World Health Organization Quality of Life Instruments (WHOQOL-BREF) from baseline to 16 weeks

时间窗: Baseline and 16 weeks.

This is a scale of quality of life. The range for total is 26-130. A higher score means a better outcome.

Chang in Activities of Daily Living from baseline to 16 weeks

时间窗: Baseline and 16 weeks

This is a scale of physical function. The range for total score is 0-100. A Higher score means a worse outcome.

Chang in Instrumental activities of daily living from baseline to 16 weeks

时间窗: Baseline and 16 weeks

This is a scale of physical function. The range for total score is 0-24. A Higher score means a better outcome.

Chang in Clinical Dementia Rating from baseline to 16 weeks

时间窗: Baseline and 16 weeks

Mental Function Assessment. The range is 0-3. A Higher score means a worse outcome.

Demographic attributes

时间窗: Baseline

Gender, education, age, married status, religion, medication, diseases, work and height.

Chang in PERSONAL WELLBEING INDEX from baseline to 16 weeks

时间窗: Baseline and 16 weeks

The range for total is 0-80. A higher score means a better outcome.

Chang in PERSONAL WELLBEING INDEX intellectual disability from baseline to 16 weeks

时间窗: Baseline and 16 weeks.

The range for total is 0-70. A higher score means a better outcome.

Chang in weight of muscle and fat from baseline to 16 weeks

时间窗: Baseline and 16 weeks

muscle mass(kg), fat mass (kg)

Chang in Four-Meter Gait Speed from baseline to 16 weeks

时间窗: Baseline and 16 weeks.

Measured with seconds. A higher score means a worse outcome.

研究点 (1)

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