## Protocol Section
### Identification Module
**NCT ID:** NCT06432062

**Brief Title:** Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia

**Official Title:** Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia

#### Organization Study ID Info
**ID:** 2022-13596
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Saglik Bilimleri University
### Status Module
#### Completion Date
**Date:** 2024-05-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-04-15

**Type:** ACTUAL

#### Start Date
**Date:** 2023-09-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul Saglik Bilimleri University

#### Responsible Party

**Investigator Affiliation:** Istanbul Saglik Bilimleri University

**Investigator Full Name:** Hatice Karabulut

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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. 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 Module

**Conditions:**

- Muscle Weakness

**Keywords:**

- rectus abdominis

- erector spinae

- thoracolumbar fascia

### Design Module

#### Design Info

**Observational Model:** CASE_CROSSOVER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 45

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Thoracolumbal Fascia Viscoelastic Properties

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Description:** 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.

**Measure:** Fatigue Assessment with Borg Scale

**Time Frame:** 2 weeks

**Description:** 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.

**Measure:** Investigations of Recovery Times

**Time Frame:** 2 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Istanbul Health Science University

**State:** Uskudar

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M20944

- Name: Muscle Weakness

- Relevance: HIGH

- As Found: Muscle Weakness

- ID: M13204

- Name: Paresis

- Relevance: LOW

- As Found: Unknown

- ID: M4554

- Name: Asthenia

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018908

- Term: Muscle Weakness

### Misc Info Module

- Version Holder: 2024-05-31
