The Investigation of Mechanical Properties in Obesity.

The Affect of Obesity to Muscle Tone and Viscoelastic Properties

The study will demonstrate the relation between muscle tone and viscoelastic properties with the body mass index.

Study Overview

• Status: Completed
• Conditions: Obesity; Body Fat Disorder; Muscular Tone; Viscoelasticity
• Intervention / Treatment: Diagnostic test: Myotonometric assessment

Detailed Description

Obesity is an increasingly important health problem. It can be defined as excessive fat accumulation. Obesity is a low-severity systemic inflammatory condition that predisposes to chronic diseases.Obesity is closely related to adipose tissue, it can have direct or indirect effects on physical activity and musculoskeletal system. The systems working with oscillation techniques, subcutaneous tissue thickness may affect the probe stroke of the device and oscillation in the tissue. In previous studies were investigated mechanical properties, and BMI used as exclusion criteria is over 30 kg/meter square or keeping it at certain intervals (18-28 kg /meter square) but this proof is not demonstrated and still lack.This study is planned to determine the relation of mechanical properties (tone, stiffness and elasticity) obtained by myotonometric assessment with body mass index.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey, 27144
    • Hasan Kalyoncu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index (range; 18 - 35 kg/meter square)

Exclusion Criteria:

• Had any systemic or metabolic disease, psychological illness, or drug use,
• Had any disease that may cause muscle disease or muscle atrophy,
• musculoskeletal surgery for the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal; Body mass index must to be in range limits (18.5-24.9 kg/meter square)	Diagnostic test: Myotonometric assessment; MyotonPro device is vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.These stimulations induce damped natural oscillations in the tissue and the device records these oscillations using an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device
Experimental: Overweight; Body mass index must to be in range limits (25-29.9 kg/meter square)	Diagnostic test: Myotonometric assessment; MyotonPro device is vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.These stimulations induce damped natural oscillations in the tissue and the device records these oscillations using an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device
Experimental: Obese; Body mass index must to be in range limits (30-34.9 kg/meter square)	Diagnostic test: Myotonometric assessment; MyotonPro device is vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.These stimulations induce damped natural oscillations in the tissue and the device records these oscillations using an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stiffness obtained from myotonometric assessment	Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Stiffness (N/m) is calculated by device	Baseline
Tone obtained from myotonometric assessment	Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Tone (Hz) is calculated by device	Baseline
Elasticity obtained from myotonometric assessment	Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Elasticity (log) is calculated by device.	Baseline

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University
• Investigators: Principal Investigator: Serkan Usgu, HKU

Publications and helpful links

General Publications

• Mechelli F, Arendt-Nielsen L, Stokes M, Agyapong-Badu S. Validity of Ultrasound Imaging Versus Magnetic Resonance Imaging for Measuring Anterior Thigh Muscle, Subcutaneous Fat, and Fascia Thickness. Methods Protoc. 2019 Jul 10;2(3):58. doi: 10.3390/mps2030058.
• Wood S, Pearsall DJ, Ross R, Reid JG. Trunk muscle parameters determined from MRI for lean to obese males. Clin Biomech (Bristol, Avon). 1996 Apr;11(3):139-144. doi: 10.1016/0268-0033(95)00018-6.
• Tas S, Yilmaz S, Onur MR, Soylu AR, Altuntas O, Korkusuz F. Patellar tendon mechanical properties change with gender, body mass index and quadriceps femoris muscle strength. Acta Orthop Traumatol Turc. 2017 Jan;51(1):54-59. doi: 10.1016/j.aott.2016.12.003. Epub 2016 Dec 20.
• Kocur P, Tomczak M, Wiernicka M, Goliwas M, Lewandowski J, Lochynski D. Relationship between age, BMI, head posture and superficial neck muscle stiffness and elasticity in adult women. Sci Rep. 2019 Jun 11;9(1):8515. doi: 10.1038/s41598-019-44837-5.
• Kuo WH, Jian DW, Wang TG, Wang YC. Neck muscle stiffness quantified by sonoelastography is correlated with body mass index and chronic neck pain symptoms. Ultrasound Med Biol. 2013 Aug;39(8):1356-61. doi: 10.1016/j.ultrasmedbio.2012.11.015. Epub 2013 May 15.
• Faria A, Gabriel R, Abrantes J, Bras R, Moreira H. Triceps-surae musculotendinous stiffness: relative differences between obese and non-obese postmenopausal women. Clin Biomech (Bristol, Avon). 2009 Dec;24(10):866-71. doi: 10.1016/j.clinbiomech.2009.07.015. Epub 2009 Aug 22.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 13, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Body mass index; Tone; Viscoelasticity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2020/101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No