The Investigation of Mechanical Properties in Obesity.

NCT04721431 | Completed DMC

• 1 other identifier: 2020/101
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Body Fat Disorder; Obesity; Muscular Tone; Viscoelasticity

Keywords

Body mass index; Tone; Viscoelasticity; Obesity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Normal

EXPERIMENTAL

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

Diagnostic Test: Myotonometric assessment

Overweight

EXPERIMENTAL

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

Diagnostic Test: Myotonometric assessment

Obese

EXPERIMENTAL

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

Diagnostic Test: Myotonometric assessment

Interventions

Myotonometric assessment 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

Normal; Obese; Overweight

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan kalyoncu üniversity

Gaziantep, 27144, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 31295936 BACKGROUND

• 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.

  PMID: 11415611 BACKGROUND

• 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.

  PMID: 28010997 BACKGROUND

• 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.

  PMID: 31186509 RESULT

• 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.

  PMID: 23683408 RESULT

• 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.

  PMID: 19703726 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serkan Usgu

  hku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of professeur

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: December 12, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 1, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)