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Clinical Trials/NCT02345083
NCT02345083
Unknown
N/A

Indonesia Frailty, Aging, and Longitudinal Study

Indonesia University1 site in 1 country300 target enrollmentJune 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frailty
Sponsor
Indonesia University
Enrollment
300
Locations
1
Primary Endpoint
Change from baseline in frailty status at 1 year
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
August 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Siti Setiati

Indonesia Frailty, Aging, and Quality of Life

Indonesia University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Change from baseline in frailty status at 1 year

Time Frame: Baseline and at 1 year

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

Secondary Outcomes

  • 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)

Study Sites (1)

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