Indonesia Frailty, Aging, and Longitudinal Study

NCT ID: NCT02345083

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Frailty Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Siti Setiati

Indonesia Frailty, Aging, and Quality of Life

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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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

Tirza Tamin, MD, PhD

Role: STUDY_CHAIR

Department of Rehabilitation & Physical 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

Locations

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Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Siti Setiati, Prof, MD

Role: CONTACT

Facility Contacts

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Rahmi Istanti, SKM, MARS

Role: primary

References

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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

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INA-FRAGILE01

Identifier Type: -

Identifier Source: org_study_id

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