Skip to main content
OpenTrials
Completed

NCT Number: NCT02333552

Frailty Status and Quality of Life in Elderly

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from baseline in frailty status at 24 months

    Time frame: Baseline and at 24 months

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

Secondary outcomes

  1. Change from baseline in mortality at 24 months

    Time frame: at 24 months

    Mortality: number of subjects died after 24 months observation.

  2. Change from baseline in morbidities at 24 months

    Time frame: Baseline and at 24 months

    Morbidities: number of diseases in subjects (using Charlson Comorbidity Index)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2015
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.