Frailty Status and Quality of Life in Elderly

NCT ID: NCT02333552

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 269 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Frailty; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Siti Setiati

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siti Setiati, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

Purwita Laksmi, MD

Role: STUDY_CHAIR

Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

Rahmi Istanti, SKM, MARS

Role: STUDY_CHAIR

Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

References

Lee JS, Auyeung TW, Leung J, Kwok T, Woo J. Transitions in frailty states among community-living older adults and their associated factors. J Am Med Dir Assoc. 2014 Apr;15(4):281-6. doi: 10.1016/j.jamda.2013.12.002. Epub 2014 Feb 16.

Reference Type: BACKGROUND

PMID: 24534517 (View on PubMed)

Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. No abstract available.

Reference Type: BACKGROUND

PMID: 25348178 (View on PubMed)

Other Identifiers

INA-FRAGILE00

Identifier Type: -

Identifier Source: org_study_id