Clinical trial NCT04650789: Longitudinal Study of Frailty in Shanghai Older People
Official title: Longitudinal Study of Frailty in Shanghai Older People
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Keywords: Frailty
Longitudinal cohort study
prevalence
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 6000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cluster random sampling was used in urban and rural areas of Shanghai

Brief summary: To investigate the prevalence of Frailty in community older residents.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The level of frailty
timeFrame: baseline
Secondary outcomes:
measure: Clock Drawing Test
timeFrame: baseline
measure: Mini-Mental State Examination (MMSE)
timeFrame: baseline
measure: Skeletal muscle mass index (SMI)
timeFrame: baseline
measure: Markers of frailty
timeFrame: baseline
measure: Routine inspection
timeFrame: baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Geriatric Institute of Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Geriatric Institute of Chinese Medicine
name: Chuan Chen
role: PRINCIPAL_INVESTIGATOR
References: