- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05638035
Effects of Obesity on Rectus Femoris Muscle Thickness, Sarcopenia, Gait and Balance in Women
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Centre
-
Kütahya, Centre, Turkey
- Kütahya Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
non-obese women
After obtaining demographic information for women with a BMI of 18-27.9
kg/m2 for at least 6 months, Body Mass Index (BMI) will be calculated and the relationship between rectus femoris muscle thickness, sarcopenia, gait and balance will be evaluated and will be compared with obese group.
|
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. |
|
obese women
After obtaining demographic information in women with a BMI of 30-39.9
kg/m2, Body Mass Index (BMI) will be calculated and the relationship between obesity and rectus femoris muscle thickness, sarcopenia, gait and balance will be evaluated.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rectus femoris muscle thickness
Time Frame: baseline
|
Measurement of muscle thickness with ultrasound
|
baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: yagmur kuralay, Kütahya Health Sciences University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSA2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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