BloatingNCT06659874
Investigation of the Relationship Between Core Muscles Functions and Symptoms of Patients with Abdominal Bloating/Distension
An observational study of Bloating and Distension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Bloating, Distension
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Sep 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the Gastroenetrology Clinic at Ege University Hospital.
Who may be able to join
- 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\"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- Conditions
- Bloating, Distension
- Keywords
- abdominal bloating/distension, core muscles, electromyography
- Medical subject headings
- Dilatation, Pathologic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At the time of the initial physiotherapist examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloatingStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University Medical School, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Melahat AKTAŞ, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659874
- Sponsor's protocol ID
- 2022/35-14
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Core Muscles Functions and Symptoms of Patients with Abdominal Bloating/Distension
- ClinicalTrials.gov ID
- NCT06659874
- Acronym / sponsor ID
- 2022/35-14
- Conditions
- Bloating, Distension
- Keywords
- abdominal bloating/distension, core muscles, electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Ege University Medical School, The Scientific and Technological Research Council of Turkey
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 26 Oct 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 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?
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the Gastroenetrology Clinic at Ege University Hospital.
Key inclusion criteria (3 listed)
- 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\"
Key exclusion criteria (7 listed)
- 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)
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
Superficial Electromyography (EMG)
Time frame: At the time of the initial physiotherapist examination
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.
Ultrasonography (USG)
Time frame: At the time of the initial physiotherapist examination
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
MIP-MEP Measurement
Time frame: At the time of the initial physiotherapist examination
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.
Gastrointestinal Symptom Rating Scale
Time frame: At the time of the initial physiotherapist examination
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.
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 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Bloating
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Wheat Flour Milling Method on Glycemic Response and Gastrointestinal Symptoms
Gastrointestinal Irritation, Nutrition, Healthy
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
Recruiting
A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women
Bloating, Gastrointestinal Symptoms
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 Bloating and Distension, run by Dokuz Eylul 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 3 inclusion and 7 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 26 Oct 2024. 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?
Superficial Electromyography (EMG) (time frame: At the time of the initial physiotherapist examination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2024.