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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05638035
Other study ID # DSA2022
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 15, 2022
Est. completion date June 15, 2023

Study information

Verified date November 2022
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Research; It is a planned, non-invasive, controlled study in obese female volunteers and non-obese female volunteers. The population of the study consists of voluntarily non-obese women and obese women. Sarcopenia assets of individuals will be measured with the sarc-f questionnaire, and then muscle strength, muscle mass and physical performance tests will be measured. Then, rectus femoris muscle thickness will be measured with USG, and then walking and balance will be measured with ZEBRIS.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1
Est. completion date June 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being over 18 years old and female - Volunteering and accepting to participate in the study - BMI 30-39.9 kg/m2 in obese women (experimental group) - BMI 18-27.9 kg/m2 in non-obese women (control group) - Not having cardiorespiratory, neurological, orthopedic and metabolic disorders Exclusion Criteria: - Being under 18 years old and male - Having a BMI of 40.0 kg/m2 and above in obese women (experimental group) - BMI 28.0 kg/m2 and above in non-obese women (control group) - Having cardiorespiratory, neurological, orthopedic and metabolic disorders

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasonografi, Sarcopenia measurement, Zebris
The rectus femoris muscle thickness of the participants will be performed in B mode via USG (Mindray-UMT 200,USA) with a multifrequency (7-15 MHz) linear probe and the measurement will be reported. TANITA for sarcopenia, hand grip strength and walking speed will be evaluated. Gait time-distance parameters and Static balance COP parameters (COP speed (cm/s) and COP length (cm)) will be recorded using Zebris™ FDM-2.

Locations

Country Name City State
Turkey Kütahya Health Sciences University Kütahya Centre

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Ates Bulut E, Soysal P, Dokuzlar O, Kocyigit SE, Aydin AE, Yavuz I, Isik AT. Validation of population-based cutoffs for low muscle mass and strength in a population of Turkish elderly adults. Aging Clin Exp Res. 2020 Sep;32(9):1749-1755. doi: 10.1007/s40520-019-01448-4. Epub 2020 Jan 2. — View Citation

Dutil M, Handrigan GA, Corbeil P, Cantin V, Simoneau M, Teasdale N, Hue O. The impact of obesity on balance control in community-dwelling older women. Age (Dordr). 2013 Jun;35(3):883-90. doi: 10.1007/s11357-012-9386-x. Epub 2012 Feb 10. — View Citation

Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rectus femoris muscle thickness Measurement of muscle thickness with ultrasound baseline
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