The Investigation of Mechanical Properties in Obesity.

Obesity Clinical Trial

Official title:

The Affect of Obesity to Muscle Tone and Viscoelastic Properties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721431
• Other study ID #: 2020/101
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 1, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Fat Disorder
• Muscular Tone
• Obesity
• Viscoelasticity

Intervention

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

Locations

Country	Name	City	State
Turkey	Hasan kalyoncu üniversity	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Faria A, Gabriel R, Abrantes J, Brás 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.2009.07.01 — View Citation

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. — View Citation

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 — View Citation

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). pii: E58. doi: 10.3390/mps2030058. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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