Klinisk prövning på Svaghet - Kliniska prövningsregister

Studieöversikt

Status

Okänd

Betingelser

Svaghet

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

6000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Kina
- Shanghai
  - Shanghai, Shanghai, Kina, 200000
    - Rekrytering
    - Shanghai Geriatric Institute of Chinese Medicine
    - Kontakt:
      
      Chuan Chen
      
      Telefonnummer: 86-21-64720010
      
      E-post: ch9453@126.com

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år till 85 år (Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
The level of frailty Tidsram: baseline	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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Shanghai University of Traditional Chinese Medicine

Utredare

Huvudutredare: Chuan Chen, Shanghai Geriatric Institute of Chinese Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2018

Primärt slutförande (Förväntat)

31 december 2021

Avslutad studie (Förväntat)

31 december 2021

Studieregistreringsdatum

Först inskickad

24 augusti 2020

Först inskickad som uppfyllde QC-kriterierna

24 november 2020

Första postat (Faktisk)

3 december 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)