NCT05638035

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

December 6, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 25, 2022

Last Update Submit

November 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rectus femoris muscle thickness

    Measurement of muscle thickness with ultrasound

    baseline

Study Arms (2)

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

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

Interventions

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.

non-obese womenobese women

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women will be included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of the research consists of voluntarily non-obese women residing in Kütahya/Center and obese women voluntarily participating in the study at Kütahya Evliya Çelebi Training and Research Hospital Physical Therapy and Rehabilitation Hospital Obesity School.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University

Kütahya, Centre, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 26655919BACKGROUND
  • 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.

    PMID: 22318311BACKGROUND
  • 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.

    PMID: 31898170BACKGROUND

MeSH Terms

Conditions

SarcopeniaObesity

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • yagmur kuralay

    kütahya health sciences university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 6, 2022

Study Start

October 15, 2022

Primary Completion

March 15, 2023

Study Completion

June 15, 2023

Last Updated

December 6, 2022

Record last verified: 2022-11

Locations