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临床试验/NCT02333552
NCT02333552已完成不适用

A Cohort Study of Frailty Status Transition and Its Impact to Quality of Life in Outpatient Elderly

Indonesia University0 个研究点目标入组 269 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
269
主要终点
Change from baseline in frailty status at 24 months

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 of frailty transitional status and its correlation with quality of life in Indonesian elderly outpatients.

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 off ers 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 of frailty transitional status and its correlation with quality of life 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 24 months

时间窗: Baseline and at 24 months

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

次要结局

  • Change from baseline in mortality at 24 months(at 24 months)
  • Change from baseline in morbidities at 24 months(Baseline and at 24 months)

研究者

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

Siti Setiati

Prof. Siti Setiati, MD, PhD, SpPD-KGer, MEpid

Indonesia University

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