Frailty Status and Quality of Life in Elderly

Completed

• Conditions: Frailty; Quality of Life

• Registration Number: NCT02333552
• Lead Sponsor: Indonesia University

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

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 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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-04
• Study Completion: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-02
• Study First Submitted QC: 2015-01-06
• Last Update Submitted: 2015-01-06
• Study First Posted: 2015-01-07
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in frailty status at 24 months	Baseline and at 24 months	Frailty status is divided into Fit (robust), Pre-frail, and Frailty.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mortality at 24 months	at 24 months	Mortality: number of subjects died after 24 months observation.
Change from baseline in morbidities at 24 months	Baseline and at 24 months	Morbidities: number of diseases in subjects (using Charlson Comorbidity Index)