Essais cliniques sur Fragilité - Registre des essais cliniques

Aperçu de l'étude

Statut

Inconnue

Les conditions

Fragilité

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

6000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Chine
- Shanghai
  - Shanghai, Shanghai, Chine, 200000
    - Recrutement
    - Shanghai Geriatric Institute of Chinese Medicine
    - Contact:
      
      Chuan Chen
      
      Numéro de téléphone: 86-21-64720010
      
      E-mail: ch9453@126.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans à 85 ans (Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
The level of frailty Délai: 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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai University of Traditional Chinese Medicine

Les enquêteurs

Chercheur principal: Chuan Chen, Shanghai Geriatric Institute of Chinese Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2018

Achèvement primaire (Anticipé)

31 décembre 2021

Achèvement de l'étude (Anticipé)

31 décembre 2021

Dates d'inscription aux études

Première soumission

24 août 2020

Première soumission répondant aux critères de contrôle qualité

24 novembre 2020

Première publication (Réel)

3 décembre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)