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Indonesia Frailty, Aging, and Longitudinal Study

Indonesia Frailty, Aging, and Longitudinal Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02345083
Acronym
INA-FRAGILE
Enrollment
300
Registered
2015-01-26
Start date
2015-06-30
Completion date
2016-08-31
Last updated
2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Quality of Life

Keywords

Frailty, Pre-frailty, Fit, Robust, Elderly, Sociodemography status, Functional status, Cognitive status, Nutrition status, Comorbidity, Polypharmacy, Mortality, Depression status, Health-related quality of life, Fall incidence, Hospitality

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.

Interventions

None listed

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in frailty status at 1 yearBaseline and at 1 yearFrailty status is divided into Fit (robust), Pre-frail, and Frailty.

Secondary

MeasureTime frameDescription
Change from baseline in health-related quality of life at 1 yearBaseline and at 1 yearHealth-related quality of life: using Euro Quality of Life-5 Dimension (EQ-5D) questionnaire.
Change from baseline in fall incidence at 1 yearBaseline and at 1 yearFall incidence: number of fall during observational period.
Change from baseline in hospitality at 1 yearBaseline and at 1 yearHospitality: number of hospital admission (emergency or inpatient care) during observational period.
Change from baseline in mortality at 1 yearBaseline and at 1 yearMortality: number of subjects died after 1 year observation.

Other

MeasureTime frameDescription
Change from baseline in cognitive status at 1 yearBaseline and at 1 yearMeasurement: Abbreviated mental test (AMT) questionnaire.
Change from baseline in mental status at 1 yearBaseline and at 1 yearMeasurement: Short Form Geriatric Depression Scale (GDS) questionnaire.
Change from baseline in comorbidities status at 1 yearBaseline and at 1 yearMeasurement: Cumulative Illness Rating Scale (CIRS)
Change from baseline in sarcopenia status at 1 yearBaseline and at 1 yearCategories: no sarcopenia, pre-sarcopenia, sarcopenia, and severe sarcopenia.
Change from baseline in nutritional status at 1 yearBaseline and at 1 yearMeasurement: Mini Nutritional Assessment (MNA) questionnaire.
Change from baseline in handgrip strength at 1 yearBaseline and at 1 yearMeasurement: using Jamar Hydraulic Hand Dynamometer Model J00105
Change from baseline in gait speed at 1 yearBaseline and at 1 yearMeasurement: 15-feet walking test
Change from baseline in functional status at 1 yearBaseline and at 1 yearMeasurement: Barthel Index Activities of Daily Living (B-ADL) & Lawton Instrumental & Activities of Daily Living (L-IADL) questionnaires.

Countries

Indonesia

Contacts

Primary ContactSiti Setiati, Prof, MD
s_setiati@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026