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临床试验/NCT02345083
NCT02345083Unknown不适用

Indonesia Frailty, Aging, and Longitudinal Study

Indonesia University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Change from baseline in frailty status at 1 year

研究概览

简要总结

Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in Indonesian elderly.

This study was aimed to define the risk factors and clinical outcomes of frailty transitional status in Indonesian elderly.

详细描述

Frailty is an age-associated, biological syndrome characterized by decreased biological reserves, due to dysregulation of several physiological systems, which puts an individual at risk when facing minor stressors, and is associated with poor outcomes (ie, disability, death, and hospitalization).

Frailty identifies a high-risk subgroup and offers characteristics of great clinical importance: a higher reversibility at early stages than disability, and a higher predictive value than chronic disease for adverse outcomes at older ages. It is also the most common condition leading to death in community-dwelling older people.

However, there is current consensus that physical frailty is potentially reversible. It is hence useful to objectively detect frailty among frail elderly persons, as frailty indices serve a useful purpose for risk stratification, predicting need for institutional care and planning of services needed.

To date, there is no study or information about frailty status in Indonesia elderly. This study was aimed to define the risk factors and clinical outcomes of frailty transitional status in Indonesian elderly.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly aged >= 60 years old
  • Fit (robust) or pre-frailty;
  • Capable to understand and carry-out the instruction.

排除标准

  • Unwilling to join the study;
  • Abbreviated Mental Test (AMT) score < 8;
  • Geriatric Depression Scale (GDS) score >= 10;
  • Body mass index (BMI) <18,5 Kg/m2;
  • Malnutrition (according to Mini Nutritional Assessment/MNA);
  • Liver cirrhosis, severe liver dysfunction, or serum ALT levels >3 times upper normal limit;
  • Acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale >6/10), stroke attack, crisis hypertension;
  • Severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification);
  • Severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (GOLD classification), and/or PaO2 levels < 60 mmHg.

结局指标

主要结局

Change from baseline in frailty status at 1 year

时间窗: Baseline and at 1 year

Frailty status is divided into Fit (robust), Pre-frail, and Frailty.

次要结局

  • Change from baseline in mortality at 1 year(Baseline and at 1 year)
  • Change from baseline in health-related quality of life at 1 year(Baseline and at 1 year)
  • Change from baseline in fall incidence at 1 year(Baseline and at 1 year)
  • Change from baseline in hospitality at 1 year(Baseline and at 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siti Setiati

Indonesia Frailty, Aging, and Quality of Life

Indonesia University

研究点 (1)

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