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Longitudinal Study of Frailty in Shanghai Older People

To investigate the prevalence of Frailty in community older residents.

研究概览

地位

未知

条件

详细说明

Detailed Description:

  1. Objective:

    • To investigate the prevalence of Frailty in community older residents.
    • To explore the causes and risk factors of frailty.
  2. Method:

    • The survey is a Community-based, multicenter prospective cohort study.

      1). 6,000 participants are expected to be included.

    • Through a questionnaire and physical examination form, carries on the investigation to the more than 65 years old people during the 3-year follow-up period.
    • The questionnaires include survey date, participant characteristics and related risk factors, such as comprise demographic characteristics, Chinese ethnic nationality, marital status, education level, family incomes, occupation, pregnancy and parity history, menstrual history, frequency and amount of daily smoking and alcohol drinking, frequency of urination and defecation, dietary habits, hours per day of sleep and sun exposure. Medical history including medication use and disease status for comorbidities, will be obtained from participants' medical records. Syndrome differentiation of deficiency of the five zang-organs in TCM will be analyzed.
    • Height and body weight will be measured for body mass index (BMI) calculation. The waist circumference and hip circumference will be recorded, and the ratios calculated. The muscle strengths of both hands will be measured with a hand dynamometer. Each of these measures will be assessed twice and the average score used in analyses.
    • Subjects will be asked to walk a distance of 4 meters and record the time at the same time to measure the walking speed.
    • Clock Drawing Test (CDT), physical frailty examination, Mini-Mental State Examination (MMSE), Skeletal muscle mass index (SMI) will also be conducted or calculated .
    • Each participant will provide a total of 7 mL of venous blood after an overnight fast (10-hour).

After being collected, markers of frailty will be measured, such as Interleukin-6 (IL-6), insulin-like growth factor-1 (IGF-1) and estrogen (E). And blood routine, urine routine, liver and kidney function, fasting plasma glucose, serum lipid will be detected.

  • Physicians in each community as the backbone, Shanghai Geriatric Institute of Chinese Medicine is responsible for personnel training.
  • Shanghai community health service centers are responsible for organization and coordination.

研究类型

观察性的

注册 (预期的)

6000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Chuan Chen
  • 电话号码:86-21-64720010
  • 邮箱ch9453@126.com

学习地点

    • Shanghai
      • Shanghai、Shanghai、中国、200000
        • 招聘中
        • Shanghai Geriatric Institute of Chinese Medicine
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 至 85年 (年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Cluster random sampling was used in urban and rural areas of Shanghai

描述

Inclusion Criteria:

  • more than 65 years old
  • Permanent residence in Shanghai and long-term residence in the community implemented by this project (more than five years)
  • Be willing to and be able to join in the study and signed Informed consent.

Exclusion Criteria:

  • Excluding the patients whose physical function is affected by diseases or disabilities such as stroke, Parkinson's disease, tumor, fracture, etc.
  • Excluding schizophrenia, depression, anxiety and other mental diseases and dependent on drug control.
  • If they were unable to complete the study survey.
  • Unwilling to join in the study and don't sign Informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

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
The level of frailty
大体时间:baseline
  1. Unexpected significant weight loss(>5%).
  2. Decreased strength: male grip strength ≤25 kg and female grip strength ≤18 kg
  3. Reduced physical activity in the last month.
  4. Slow walking speed is less than or equal to 0.8 m/s.
  5. How tired you feel for the last month? The frailty period was defined as ≥3 items, early frailty was defined as 1-2 items, and non-frailty was defined as 0 items.
baseline

次要结果测量

结果测量
措施说明
大体时间
Clock Drawing Test
大体时间:baseline
The subjects were scored on a four-point scale by drawing a clock face on a piece of white paper.
baseline
Mini-Mental State Examination (MMSE)
大体时间:baseline
Two or three points in the drawing clock test were measured using the MMSE.
baseline
Skeletal muscle mass index (SMI)
大体时间:baseline
The ratio of skeletal muscle weight to height squared was measured by DXA.
baseline
Markers of frailty
大体时间:baseline
Markers of frailty, such as Interleukin-6 (IL-6), insulin-like growth factor-1 (IGF-1) and estrogen (E).
baseline
Routine inspection
大体时间:baseline
Fasting peripheral blood collected 4ml. blood routine, urine routine, liver and kidney function, fasting plasma glucose, serum lipid.
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Chuan Chen、Shanghai Geriatric Institute of Chinese Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月1日

初级完成 (预期的)

2021年12月31日

研究完成 (预期的)

2021年12月31日

研究注册日期

首次提交

2020年8月24日

首先提交符合 QC 标准的

2020年11月24日

首次发布 (实际的)

2020年12月3日

研究记录更新

最后更新发布 (实际的)

2020年12月3日

上次提交的符合 QC 标准的更新

2020年11月24日

最后验证

2020年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Shanghai Frailty Survey

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

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