Investigation of the Relationship Between Core Muscles Functions and Symptoms of Patients with Abdominal Bloating/Distension

The aim of this study is to investigate the relationship between core muscle functions (strength, endurance, thickness) and symptoms in individuals with abdominal bloating/distension. The main questions it aims to answer are:

Does symptoms in individuals with abdominal bloating/distension have an effect on core muscles? How do core muscles change based on an increase or decrease in these symptoms?

Study Overview

• Status: Completed
• Conditions: Bloating; Distension

Detailed Description

In studies on individuals with abdominal bloating/distension in the literature, the diaphragm, abdominal muscles, and pelvic floor muscles have been examined separately. There is no study that examines all core muscles together in such cases. Additionally, there is no study examining the relationship between core muscle function and symptoms. Therefore, the aim of our study is to investigate the relationship between core muscle functions (strength, endurance, thickness) and symptoms in individuals with abdominal bloating/distension.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Turkey
  • İzmir
    • Balçova, İzmir, Turkey, 35330
      • Dokuz Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients referred to the Gastroenetrology Clinic at Ege University Hospital.

Description

Inclusion Criteria:

• Have a diagnosis of abdominal bloating/distension made by a physician according to the Rome IV Criteria
• Be female between 18 and 65 years of age
• Volunteer to participate"

Exclusion Criteria:

• Having a serious neurological, pulmonary, systemic, orthopedic, or metabolic disease accompanying bloating-distension
• Being under 18 or over 65 years of age
• Being pregnant
• Having any organic cause for bloating and distension (such as celiac disease or other absorption disorders, intestinal dysmotility, and chronic intestinal pseudo-obstruction)
• Having alarm symptoms (weight loss, rectal bleeding, or anemia)
• Having a Body Mass Index (BMI) ≥40
• Having a history of gastrointestinal (GI) or abdominolumbopelvic surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superficial Electromyography (EMG)	A NeuroTrac MyoPlus 4 PRO (Verity Medical LTD., UK) type EMG device will be used in the study. Bioelectrical activities of the muscles (pelvic floor muscles, abdominal muscles, diaphragm, multifidus, erector spina) will be recorded with disposable 3.2 x 3.2 cm superficial electrodes. To reduce skin impedance, the skin area will be cleaned with an alcohol swab. Active electrodes will be placed on the right side of the body, parallel to the muscle fibers, according to the reference points. The reference electrode will be placed on the anterior superior iliac spine. Measurements will be performed during six seconds of maximal voluntary contraction ('work' phase EMG activity) and sixseconds of relaxation ('rest' phase EMG activity) of the pelvic floor muscles. Measurements will be repeated for three times. The graphic and numerical data provided by the device will be recorded in the evaluation form.	At the time of the initial physiotherapist examination
Ultrasonography (USG)	Pelvic floor displacement, bladder wall thickness and, abdominal muscles, multifidus, erector spina, diaphragma, intercostal muscle thicknesses, anorectal angle, anopubıc angle will be measured. A transabdominal diagnostic USG device (Sonospace SSI-600) with a low frequency (2-5 MHz) curvilinear transducer will be used. Muscle thickness and distance measurements will be made during frozen imaging. Muscle thickness will be measured between the upper border of the muscle fascia, which appears as a white line, and the end point of the lower border. Measurements will be taken at the expiration and during a five-second pelvic floor muscle contraction. Both measurement results will be recorded in millimeters. All measurements will be repeated three times and the average values will be noted on the evaluation form	At the time of the initial physiotherapist examination
MIP-MEP Measurement	One of the most commonly used non-invasive methods for evaluating respiratory muscles is the measurement of Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP). These are pressures measured within the oral cavity during maximal respiration against a closed airway. MIP (Maximum Inspiratory Pressure) is the highest pressure generated to open closed alveoli at the level of residual volume (actually negative pressure). For the test, the subject is asked to perform maximum expiration, and at the end of this, the airway is occluded with a valve, prompting the individual to perform maximum inspiration and sustain it for 1-3 seconds. MEP (Maximum Expiratory Pressure), on the other hand, is the highest pressure required to deflate over-distended alveoli at the level of total lung capacity. After instructing the individual to perform maximum inspiration for MEP measurement, they are asked to perform maximum expiration against a closed airway for 1-3 seconds.	At the time of the initial physiotherapist examination
Gastrointestinal Symptom Rating Scale	The scale evaluates how individuals have felt regarding gastrointestinal issues in the past week. The scale consists of 15 questions with 5 subscales: reflux, indigestion, diarrhea, constipation, and abdominal pain. Higher scores obtained from the scale indicate more severe symptoms.	At the time of the initial physiotherapist examination

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Collaborators: Ege University Medical School; TUBITAK 1002 PROGRAM

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: electromyography; core muscles; abdominal bloating/distension
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 2022/35-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No