もろさの臨床試験-臨床試験登録-ICH GCP

調査の概要

状態

わからない

条件

もろさ

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

6000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

中国
- Shanghai
  - Shanghai、Shanghai、中国、200000
    - 募集
    - Shanghai Geriatric Institute of Chinese Medicine
    - コンタクト：
      
      Chuan Chen
      
      電話番号：86-21-64720010
      
      メール：ch9453@126.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年～85年 (高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
The level of frailty 時間枠：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

二次結果の測定

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Shanghai University of Traditional Chinese Medicine

捜査官

主任研究者：Chuan Chen、Shanghai Geriatric Institute of Chinese Medicine

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年1月1日

一次修了 (予想される)

2021年12月31日

研究の完了 (予想される)

2021年12月31日

試験登録日

最初に提出

2020年8月24日

QC基準を満たした最初の提出物

2020年11月24日

最初の投稿 (実際)

2020年12月3日

学習記録の更新

投稿された最後の更新 (実際)