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临床试验/NCT04650789
NCT04650789Unknown不适用

Longitudinal Study of Frailty in Shanghai Older People

Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
6,000
试验地点
1
主要终点
The level of frailty

研究概览

简要总结

To investigate the prevalence of Frailty in community older residents.

详细描述

Detailed Description:

  1. Objective:
  • To investigate the prevalence of Frailty in community older residents.
  • To explore the causes and risk factors of frailty.
  1. 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).

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 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

The level of frailty

时间窗: 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.

次要结局

  • Mini-Mental State Examination (MMSE)(baseline)
  • Skeletal muscle mass index (SMI)(baseline)
  • Markers of frailty(baseline)
  • Clock Drawing Test(baseline)
  • Routine inspection(baseline)

研究者

发起方
Shanghai University of Traditional Chinese Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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