Muscle WeaknessNCT06432062
Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia
An observational study of Muscle Weakness, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
The rectus abdominis, which enables the trunk to flex with its activation, and the erector spinae muscles, which provide trunk extension with its activation, are among the structures located in the core region and involved in the stabilization of the spine. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2023to 1 Jul 2024
- Phase
- Observational
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: This study will be conducted with healthy male individuals between the ages of 18-35. Individuals without any orthopedic, neurological or chronic disease will be included in the study.
Who may be able to join
- Being a healthy individual between the ages of 18-35
- Not having any chronic disease
- Body mass index (BMI) is 24.9 kg/m2 or lower
- Volunteering to participate in the study
Who cannot join
- Having a chronic illness (Diabetes, blood pressure, etc.)
- Having a diagnosed spine problem
- Being diagnosed with scoliosis
- Pilates, yoga, etc. in the last 6 months. to have done sports
- Beighton score of 4 or above
- Being diagnosed with cardiopulmonary system disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Health Science University
Istanbul, Uskudar
About this study
The rectus abdominis, which enables the trunk to flex with its activation, and the erector spinae muscles, which provide trunk extension with its activation, are among the structures located in the core region and involved in the stabilization of the spine. While the muscles in the core area actively provide the stabilization of the medulla spinalis, this stabilization is also supported by passive subsystems. Passive subsystem fascia etc. creates structures. Thoracolumbar fascia is one of the important fascias due to its connections with the muscles in the core area. Fatigue etc. of the structures in the core area. As a result of physiological processes, their functionality may decrease, which may affect the stabilization of the core area. Fatigue occurs as a result of lactic acid accumulation in the structures in the body and this process is called the recovery period. The types of exercises performed also affect the recovery period. For this reason, different exercise types such as dynamic and static can be used when creating exercise programs. Due to the functions of the rectus abdominis and erector spinae muscles and thoracolumbar fascia in the body, their effects on the spine and their connections with each other; It is aimed to examine the effect of muscle fatigue in these muscles on the viscoelastic properties of the thoracolumbar fascia and their recovery rates.
- Conditions
- Muscle Weakness
- Keywords
- rectus abdominis, erector spinae, thoracolumbar fascia
- Medical subject headings
- Muscle Weakness
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracolumbal Fascia Viscoelastic Properties
Viscoelastic properties of the thoracolumbal fascia (TFL) was performed with the MyotonPRO™ (Myoton AS, Estonia) device. Before and after imeddiately after application of the fatigue protocol. The measurement point determined for TFL of individuals rest were marked with a medical marker pen. During the measurement, the probe of the device was adjusted to pulse once into the skin with a force of 0.4 N and for 15 ms. During the test, the tip of the MyotonPro™ device was placed perpendicular to the marked area and gently pressed against the skin at a depth of 3 mm until the green light came on.
Measured: 2 weeks
Secondary outcomes (2)
Fatigue Assessment with Borg Scale
Fatigue assessment will be made using the Modified Borg Scale. The Modified Borg Scale is a subjective evaluation method that evaluates fatigue and shortness of breath during activity or at rest between 0 and 10. 0 points "not at all" means the lowest, and 10 points "very severe" means the highest fatigue and shortness of breath.
Measured: 2 weeks
Investigations of Recovery Times
Moxy®, (Moxy®, Fortiori Design LLC, Minnesota, USA) Monitor will be used to detect the change in intramuscular oxygen saturation of the muscles and the time it takes to return to resting levels during and after fatigue protocols. The most swollen areas of the rectus abdominis and erector spinae muscles will be marked with a cosmetic pen and the device will be placed.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start20 Sep 2023
- Primary completion15 Apr 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Karabulut, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432062
- Sponsor's protocol ID
- 2022-13596
- Status last verified
- Aug 2025
- First submitted
- 8 May 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karabulut H, Varol F. Acute effects of core fatigue on thoracolumbar fascia mechanical and viscoelastic properties in healthy young adults: a cross-sectional study. Eur J Appl Physiol. 2026 Aug 6. doi: 10.1007/s00421-026-06344-0. Online ahead of print.
PubMed 42560528
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia
- ClinicalTrials.gov ID
- NCT06432062
- Acronym / sponsor ID
- 2022-13596
- Conditions
- Muscle Weakness
- Keywords
- rectus abdominis, erector spinae, thoracolumbar fascia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 29 May 2024 (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 rectus abdominis, which enables the trunk to flex with its activation, and the erector spinae muscles, which provide trunk extension with its activation, are among the structures located in the core region and involved in the stabilization of the spine. While the muscles in the core area actively provide the stabilization of the medulla spinalis, this stabilization is also supported by passive subsystems. Passive subsystem fascia etc. creates structures. Thoracolumbar fascia is one of the important fascias due to its connections with the muscles in the core area. Fatigue etc. of the structures in the core area. As a result of physiological processes, their functionality may decrease, which may affect the stabilization of the core area. Fatigue occurs as a result of lactic acid accumulation in the structures in the body and this process is called the recovery period. The types of exercises performed also affect the recovery period. For this reason, different exercise types such as dynamic and static can be used when creating exercise programs. Due to the functions of the rectus abdominis and erector spinae muscles and thoracolumbar fascia in the body, their effects on the spine and their connections with each other; It is aimed to examine the effect of muscle fatigue in these muscles on the viscoelastic properties of the thoracolumbar fascia and their recovery rates.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will be conducted with healthy male individuals between the ages of 18-35. Individuals without any orthopedic, neurological or chronic disease will be included in the study.
Key inclusion criteria (4 listed)
- Being a healthy individual between the ages of 18-35
- Not having any chronic disease
- Body mass index (BMI) is 24.9 kg/m2 or lower
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Having a chronic illness (Diabetes, blood pressure, etc.)
- Having a diagnosed spine problem
- Being diagnosed with scoliosis
- Pilates, yoga, etc. in the last 6 months. to have done sports
- Beighton score of 4 or above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thoracolumbal Fascia Viscoelastic Properties
Time frame: 2 weeks
Viscoelastic properties of the thoracolumbal fascia (TFL) was performed with the MyotonPRO™ (Myoton AS, Estonia) device. Before and after imeddiately after application of the fatigue protocol. The measurement point determined for TFL of individuals rest were marked with a medical marker pen. During the measurement, the probe of the device was adjusted to pulse once into the skin with a force of 0.4 N and for 15 ms. During the test, the tip of the MyotonPro™ device was placed perpendicular to the marked area and gently pressed against the skin at a depth of 3 mm until the green light came on.
2 secondary outcomes
Fatigue Assessment with Borg Scale
Time frame: 2 weeks
Investigations of Recovery Times
Time frame: 2 weeks
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 13 Aug 2025.
- Derived from this study: PubMed 42560528Karabulut H, Varol F. Acute effects of core fatigue on thoracolumbar fascia mechanical and viscoelastic properties in healthy young adults: a cross-sectional study. Eur J Appl Physiol. 2026 Aug 6. doi: 10.1007/s00421-026-06344-0. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Weakness, run by Istanbul Saglik Bilimleri 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 4 inclusion and 6 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 13 Aug 2025. 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?
Thoracolumbal Fascia Viscoelastic Properties (time frame: 2 weeks). 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 NCT06432062, which also lists 1 linked publication.
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 13 Aug 2025.