Longitudinal Study of Frailty in Shanghai Older People

To investigate the prevalence of Frailty in community older residents.

Study Overview

• Status: Unknown
• Conditions: Frailty

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Geriatric Institute of Chinese Medicine
      • Contact: Chuan Chen; Phone Number: 86-21-64720010; Email: ch9453@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of frailty	Unexpected significant weight loss（>5%).; Decreased strength: male grip strength ≤25 kg and female grip strength ≤18 kg; Reduced physical activity in the last month.; Slow walking speed is less than or equal to 0.8 m/s.; 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clock Drawing Test	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)	Two or three points in the drawing clock test were measured using the MMSE.	baseline
Skeletal muscle mass index (SMI)	The ratio of skeletal muscle weight to height squared was measured by DXA.	baseline
Markers of frailty	Markers of frailty, such as Interleukin-6 (IL-6), insulin-like growth factor-1 (IGF-1) and estrogen (E).	baseline
Routine inspection	Fasting peripheral blood collected 4ml. blood routine, urine routine, liver and kidney function, fasting plasma glucose, serum lipid.	baseline

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Chuan Chen, Shanghai Geriatric Institute of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: prevalence; Frailty; Longitudinal cohort study
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: Shanghai Frailty Survey

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No