Longitudinal Study of Frailty in Shanghai Older People

Frailty Clinical Trial

Official title:

Longitudinal Study of Frailty in Shanghai Older People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650789
• Other study ID #: Shanghai Frailty Survey
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2020
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Chuan Chen
• Phone: 86-21-64720010
• Email: ch9453[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the prevalence of Frailty in community older residents.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frailty

Locations

Country	Name	City	State
China	Shanghai Geriatric Institute of Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

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