Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Elderly: Study Protocol for a Randomized Multicenter Clinical Trial
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Navarra
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Pamplona、Navarra、西班牙、31008
- Complejo Hospitalario de Navarra. Department of Geriatrics
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- > 75 years
- Barthel Index ≥60 points
- Able to ambulate (with/without assistance)
- Sing the informed consent
- Able to communicate
Exclusion Criteria:
- Expected length of stay <6 days
- Terminal illness
- Very severe cognitive decline (i.e., GDS 7)
- Uncontrolled arrhythmias, acute pulmonary embolism and myocardial infarction, or extremity bone fracture in the past 3 months.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:常规护理组
日常护理
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实验性的:Training group
Multicomponent exercise group (intervention): The intervention will consist of a multicomponent exercise training programme24, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening). The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RMcombined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital. |
The intervention will consist of a multicomponent exercise training programme24, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days.
During the training period, patients will be trained in 20 min sessions twice a day.
The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RM combined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair.
The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Rate of patients with change in functional and cognitive status
大体时间:3 years
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The functional capacity of participants will be evaluated by the Short Physical Performance Battery (SPPB), the total score ranging from 0 (worst) to 12 points (best) which includes balance, gait and rising from a chair test.
Standing balance test consists in the ability to maintain the standing position for 10s with three different foot position: parallel, semi-tandem and tandem.
Walking speed measure, the time needed to progress for 4 linear meters with patient's usual speed, assigning a different score according to speed.
Chair sit-to-stand assesses the ability to stand from a chair 5 consecutive times without using arms.
The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality.
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3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Rate of changes in the quality of life
大体时间:3 years
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- Changes in the quality of life measured by the Spanish version40 of the questionnaire EuroQol-5 Dimension (EQ-5D)41.
It is an instrument measures 5 dimensions health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension is rated according to the following levels: a) no problems; b) some problems; c) extreme problems.
Besides, it contain visual analogy scale to quantify perceived health of 0 (worst health state imaginable) to 100 (best health state imaginable).
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3 years
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Number of patients with delirium
大体时间:3 years
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Development of delirium as assessed with the Confusion Assessment Method (CAM); feature 1, acute onset and fluctuating course; feature 2, inattention; feature 3, disorganized thinking; and feature 4, altered level of consciousness, with diagnosis of delirium requiring the presence of features 1 and 2 and either 3 or 442.
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3 years
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Mortality Rate
大体时间:3 years
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3-years mortality
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3 years
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Total use of health-related resources
大体时间:3 years
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Number of readmissions, visits to A&E, visits to outpatient clinics
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3 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Physical Exercise的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的