Body Fat DisorderNCT04721431
The Investigation of Mechanical Properties in Obesity.
A study testing Myotonometric assessment in people with Body Fat Disorder and Obesity, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The study will demonstrate the relation between muscle tone and viscoelastic properties with the body mass index. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Fat Disorder, Obesity, Muscular Tone
- What is being tested?
- Myotonometric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (range; 18 - 35 kg/meter square)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Body Fat Disorder, Obesity, Muscular Tone, Viscoelasticity
- Being tested
- Myotonometric assessment
- Keywords
- Body mass index, Tone, Viscoelasticity, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myotonometric assessmentDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Normal | Experimental | Body mass index must to be in range limits (18.5-24.9 kg/meter square) Receives: Diagnostic Test: Myotonometric assessment |
| Overweight | Experimental | Body mass index must to be in range limits (25-29.9 kg/meter square) Receives: Diagnostic Test: Myotonometric assessment |
| Obese | Experimental | Body mass index must to be in range limits (30-34.9 kg/meter square) Receives: Diagnostic Test: Myotonometric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start12 Dec 2020
- Primary completion28 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Body Fat DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Usgu, Hasan Kalyoncu University
- Investigators
- Serkan Usgu, Principal investigator, hku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721431
- Sponsor's protocol ID
- 2020/101
- Status last verified
- Mar 2021
- First submitted
- 20 Jan 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31295936Wood 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 11415611Tas 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 28010997Kocur 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 31186509Kuo 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 23683408Faria 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect of Obesity to Muscle Tone and Viscoelastic Properties
- ClinicalTrials.gov ID
- NCT04721431
- Acronym / sponsor ID
- 2020/101
- Conditions
- Body Fat Disorder, Obesity, Muscular Tone, Viscoelasticity
- Keywords
- Body mass index, Tone, Viscoelasticity, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will demonstrate the relation between muscle tone and viscoelastic properties with the body mass index.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normal | Experimental | Diagnostic Test: Myotonometric assessmentBody mass index must to be in range limits (18.5-24.9 kg/meter square) |
| Overweight | Experimental | Diagnostic Test: Myotonometric assessmentBody mass index must to be in range limits (25-29.9 kg/meter square) |
| Obese | Experimental | Diagnostic Test: Myotonometric assessmentBody mass index must to be in range limits (30-34.9 kg/meter square) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (range; 18 - 35 kg/meter square)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myotonometric assessmentMyotonPro 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 | Diagnostic test | Normal, Obese, Overweight |
Primary outcome
Stiffness obtained from myotonometric assessment
Time frame: Baseline
Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Stiffness (N/m) is calculated by device
Tone obtained from myotonometric assessment
Time frame: Baseline
Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Tone (Hz) is calculated by device
Elasticity obtained from myotonometric assessment
Time frame: Baseline
Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Elasticity (log) is calculated by device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 31295936Mechelli 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.
- Background: PubMed 11415611Wood 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.
- Background: PubMed 28010997Tas 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.
- Results publication: PubMed 31186509Kocur 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.
- Results publication: PubMed 23683408Kuo 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.
- Results publication: PubMed 19703726Faria 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Usgu principal investigator
hku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myotonometric assessment in people with Body Fat Disorder and Obesity, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness obtained from myotonometric assessment (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721431, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.