The Investigation of Mechanical Properties in Obesity.

NCT ID: NCT04721431

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-12

Study Completion Date

2021-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Body Fat Disorder Obesity Muscular Tone Viscoelasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The people will assigned to groups depend on body mass index. The biceps brachii (BB), biceps femoris (BF) tone, and viscoelastic properties (stiffness and elasticity) will be evaluated bilaterally using the ''MyotonPRO'' device.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Normal

Body mass index must to be in range limits (18.5-24.9 kg/meter square)

Group Type EXPERIMENTAL

Myotonometric assessment

Intervention Type DIAGNOSTIC_TEST

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

Overweight

Body mass index must to be in range limits (25-29.9 kg/meter square)

Group Type EXPERIMENTAL

Myotonometric assessment

Intervention Type DIAGNOSTIC_TEST

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

Obese

Body mass index must to be in range limits (30-34.9 kg/meter square)

Group Type EXPERIMENTAL

Myotonometric assessment

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasan Kalyoncu University

OTHER

Sponsor Role lead

Responsible Party

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Serkan Usgu

Assistant of professeur

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serkan Usgu

Role: PRINCIPAL_INVESTIGATOR

hku

Locations

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Hasan kalyoncu üniversity

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31295936 (View on PubMed)

Wood S, Pearsall DJ, Ross R, Reid JG. Trunk muscle parameters determined from MRI for lean to obese males. Clin Biomech (Bristol). 1996 Apr;11(3):139-144. doi: 10.1016/0268-0033(95)00018-6.

Reference Type BACKGROUND
PMID: 11415611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28010997 (View on PubMed)

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.

Reference Type RESULT
PMID: 31186509 (View on PubMed)

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.

Reference Type RESULT
PMID: 23683408 (View on PubMed)

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). 2009 Dec;24(10):866-71. doi: 10.1016/j.clinbiomech.2009.07.015. Epub 2009 Aug 22.

Reference Type RESULT
PMID: 19703726 (View on PubMed)

Other Identifiers

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2020/101

Identifier Type: -

Identifier Source: org_study_id

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