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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146844
Other study ID # GoztepeTRH1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 15, 2020
Est. completion date April 25, 2021

Study information

Verified date May 2021
Source Goztepe Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date April 25, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Being at the age of 65 or older Exclusion Criteria: - <24 points on Mini-Mental State Examination - 12 points or higher on Geriatric Depression Scale

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Umraniye Education and Research Hospital Istanbul

Sponsors (3)

Lead Sponsor Collaborator
Goztepe Training and Research Hospital Istanbul Medeniyet University, Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Study of Osteoporotic Fracture (SOF) Criteria for Frailty SOF is another index for measuring frailty. 2 or 3 points out of 3 points are considered as cut-off points for frailty. 5 minutes
Secondary Charlson Comorbidity Index For comorbidity assessment 5-10 minutes
Secondary Rapid Assessment of Physical Activity (RAPA) For the assessment of physical activity level 10 minutes
Secondary Mini-Nutritional Assessment (MNA) Assessment of nutritional status 10 minutes
Secondary Katz Index of Independence in Activities of Daily Living Assessment of activities of daily living 10 minutes
Secondary Lawton -Brody Instrumental Activities of Daily Living Scale Instrumental activities of daily living assessment 10 minutes
Secondary Mini-Mental State Examination Mini-Mental State Examination 15 minutes
Secondary Blood Sample Analysis A blood sample analysis will be performed to investigate the relationship between blood parameters, sarcopenia and frailty. 5 minutes
Secondary Geriatric Depression Scale- Short Form Assessment of depression 10 minutes
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