- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04650789
Longitudinal Study of Frailty in Shanghai Older People
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Detailed Description:
Objective:
- To investigate the prevalence of Frailty in community older residents.
- To explore the causes and risk factors of frailty.
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Chuan Chen
- Telefonnummer: 86-21-64720010
- E-mail: ch9453@126.com
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200000
- Rekruttering
- Shanghai Geriatric Institute of Chinese Medicine
-
Kontakt:
- Chuan Chen
- Telefonnummer: 86-21-64720010
- E-mail: ch9453@126.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The level of frailty
Tidsramme: baseline
|
|
baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Clock Drawing Test
Tidsramme: 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)
Tidsramme: baseline
|
Two or three points in the drawing clock test were measured using the MMSE.
|
baseline
|
Skeletal muscle mass index (SMI)
Tidsramme: baseline
|
The ratio of skeletal muscle weight to height squared was measured by DXA.
|
baseline
|
Markers of frailty
Tidsramme: baseline
|
Markers of frailty, such as Interleukin-6 (IL-6), insulin-like growth factor-1 (IGF-1) and estrogen (E).
|
baseline
|
Routine inspection
Tidsramme: baseline
|
Fasting peripheral blood collected 4ml.
blood routine, urine routine, liver and kidney function, fasting plasma glucose, serum lipid.
|
baseline
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Chuan Chen, Shanghai Geriatric Institute of Chinese Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Shanghai Frailty Survey
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .