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

NCT06659874 | Completed

• 1 other identifier: 2022/35-14
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Bloating; Distension

Keywords

abdominal bloating/distension; core muscles; electromyography

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred to the Gastroenetrology Clinic at Ege University Hospital.

You may qualify if:

• 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\"

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Ege University Medical School: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Dokuz Eylul University

Balçova, İzmir, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)