NCT04146844

Brief Summary

Sarcopenia and frailty are two major syndromes in older adults. They are shown to be associated with low levels of functioning and higher rates of morbidity and mortality. In this study, we aim to report the prevalence of sarcopenia and frailty by using simple assessment methods such as SARC-F and FRAIL, respectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

October 28, 2019

Last Update Submit

May 7, 2021

Conditions

SarcopeniaFrailtyFrailty Syndrome

Outcome Measures

Primary Outcomes (2)

  • SARC-F

    SARC-F is a rapid tool to assess sarcopenia in elderly. It is considered indicative sign of sarcopenia if the person scores 4 points or higher out of 10 points.

    5 minutes

  • FRAIL

    The FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight) is a simple questionnaire of frailty syndrome for older adults. If a patient scores 3-5 points over a total score of 5 points in the FRAIL, he is considered as frail.

    5 minutes

Secondary Outcomes (9)

  • Study of Osteoporotic Fracture (SOF) Criteria for Frailty

    5 minutes

  • Charlson Comorbidity Index

    5-10 minutes

  • Rapid Assessment of Physical Activity (RAPA)

    10 minutes

  • Mini-Nutritional Assessment (MNA)

    10 minutes

  • Katz Index of Independence in Activities of Daily Living

    10 minutes

  • +4 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Community-dwelling older adults

You may qualify if:

  • Being at the age of 65 or older

You may not qualify if:

  • \<24 points on Mini-Mental State Examination
  • points or higher on Geriatric Depression Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SarcopeniaFrailty

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 31, 2019

Study Start

December 15, 2020

Primary Completion

April 1, 2021

Study Completion

April 25, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)