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临床试验/NCT03541135
NCT03541135Enrolling By Invitation不适用

Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain (Seniors-ENRICA II)

Universidad Autonoma de Madrid1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
4,000
试验地点
1
主要终点
Executive function limitations on motor response control

研究概览

简要总结

Population aging makes it necessary to identify factors related to unhealthy aging. The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles and biological risk factors (either clasical or emergent) and the risk of physical and cognitive function impairment and mortality in a cohort of community-living individuals aged 65 years and over.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-institutionalized residents in the region of Madrid, Spain.
  • 65 years and over

排除标准

  • 未提供

结局指标

主要结局

Executive function limitations on motor response control

时间窗: 3 years

GO-NO-GO test.

Functional limitations on balance

时间窗: 3 years

Short Physical Performance Battery (SPPB): Balance test

Functional limitations on strength of legs

时间窗: 3 years

Short Physical Performance Battery (SPPB): Chair Stand test

Functional limitations on activities of daily living

时间窗: 3 years

Activities of Daily Living (ADLs) test

Functional limitations on instrumental activities of daily living

时间窗: 3 years

Instrumental Activities of Daily Living (IADLs) test

Functional limitations on olfactory function

时间窗: 3 years

Pocket Smell test

Cognitive impairment

时间窗: 3 years

Mini-Mental State Examination (MMSE)

Frailty

时间窗: 3 years

Fried criteria

Arterial stiffness estimated by central sistolic blood pressure (CSBP)

时间窗: 3 years

Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate CSBP (mmHg) over a 24 hours period

Mortality

时间窗: 3 years

From the National Institute of Statistics of Spain

Functional limitations on strength of hands

时间窗: 3 years

Hydraulic hand dynamometer (Jamar Plus +)

Falls

时间窗: 3 years

From the question: "How many times have you fallen down since the last interview? a) Number of falls; b) Number of injurious falls; c) Number of falls with fracture

Functional limitations on shoulder flexibility

时间窗: 3 years

Back Scratch test

Functional limitations on gait speed

时间窗: 3 years

Short Physical Performance Battery (SPPB): Gait Speed test

Memory function limitations

时间窗: 3 years

Seven Minute Screen (orientation, memory, clock drawing, verbal fluency)

Functional limitations on bicep-femoral flexibility

时间窗: 3 years

Chair Sit and Reach test

Functional limitations on taste function

时间窗: 3 years

NIH Tool Box Taste test

Functional limitations on auditory function

时间窗: 3 years

Audiometry

Executive function limitations on working memory

时间窗: 3 years

Digits Forward test (WAIS-III),

Executive function limitations on programmed motor tasks

时间窗: 3 years

Three Hand Position test of Luria

Arterial stiffness estimated by augmentation index (AI)

时间窗: 3 years

Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate AI (%) over a 24 hours period

Arterial stiffness estimated by pulse wave velocity (PWV)

时间窗: 3 years

Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate PWV (m/s) over a 24 hours period

24-h systolic and diastolic blood pressure

时间窗: 3 years

Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate brachial blood pressure (systolic and diastolic) (mmHg) over a 24 hours period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Rodríguez-Artalejo

Professor of Preventive Medicine and Public Health

Universidad Autonoma de Madrid

研究点 (1)

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