Effects of Obesity on Rectus Femoris Muscle Thickness, Sarcopenia, Gait and Balance in Women

• Sponsor: Kutahya Health Sciences University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05638035
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenic Obesity; Sarcopenia; Obesity	Diagnostic Test: Ultrasonografi, Sarcopenia measurement, Zebris

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Effects of Obesity on Rectus Femoris Muscle Thickness, Sarcopenia, Gait and Balance in Women
• Actual Study Start Date: Oct 15, 2022
• Anticipated Primary Completion Date: Mar 15, 2023
• Anticipated Study Completion Date: Jun 15, 2023

Arms and Interventions

Arm	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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures

1. Rectus femoris muscle thickness [baseline]

   Measurement of muscle thickness with ultrasound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kütahya Health Sciences University	Kütahya	Centre	Turkey

Sponsors and Collaborators

• Kutahya Health Sciences University

Investigators

• Principal Investigator: yagmur kuralay, kütahya health sciences university

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Yağmur KURALAY, physiotherapist, Kutahya Health Sciences University
• ClinicalTrials.gov Identifier: NCT05638035
• Other Study ID Numbers: DSA2022
• First Posted: Dec 6, 2022
• Last Update Posted: Dec 6, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcopenia; Obesity

Study Results

No Results Posted as of Dec 6, 2022