Ensaio clínico em Fragilidade - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Desconhecido

Condições

Fragilidade

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Antecipado)

6000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

China
- Shanghai
  - Shanghai, Shanghai, China, 200000
    - Recrutamento
    - Shanghai Geriatric Institute of Chinese Medicine
    - Contato:
      
      Chuan Chen
      
      Número de telefone: 86-21-64720010
      
      E-mail: ch9453@126.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

65 anos a 85 anos (Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
The level of frailty Prazo: 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

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai University of Traditional Chinese Medicine

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2018

Conclusão Primária (Antecipado)

31 de dezembro de 2021

Conclusão do estudo (Antecipado)

31 de dezembro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de novembro de 2020

Primeira postagem (Real)

3 de dezembro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)