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CompletedNCT04721431Updated Mar 17, 2021

The Investigation of Mechanical Properties in Obesity.

An interventional study of Myotonometric assessment in Body Fat Disorder, Obesity and Muscular Tone, sponsored by Hasan Kalyoncu University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Hasan Kalyoncu University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Body Fat Disorder
  • Obesity
  • Muscular Tone
  • Viscoelasticity

Browse trials for

Keywords

  • Body mass index
  • Tone
  • Viscoelasticity
  • Obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 300 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Hasan Kalyoncu University is the lead sponsor of 161 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Normal

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

    Diagnostic Test: Myotonometric assessment

  • Experimental
    Overweight

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

    Diagnostic Test: Myotonometric assessment

  • Experimental
    Obese

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

    Diagnostic Test: Myotonometric assessment

Interventions

  • Diagnostic testMyotonometric 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

07

Study locations

1 site
  • Hasan kalyoncu üniversity
    Gaziantep, 27144, Turkey
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References and documents

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. PubMed 31295936 ↗
  • 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. PubMed 11415611 ↗
  • 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. PubMed 28010997 ↗
  • 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. PubMed 31186509 ↗
  • 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. PubMed 23683408 ↗
  • 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. PubMed 19703726 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04721431
Lead sponsor
Hasan Kalyoncu University
Responsible party
Serkan Usgu (Assistant of professeur, Hasan Kalyoncu University) — Principal investigator
First posted
Jan 22, 2021
Start date
Dec 12, 2020
Primary completion
Feb 28, 2021
Completion
Mar 1, 2021
Last update
Mar 17, 2021

Study contacts

Serkan Usgu
principal investigator · hku

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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