Short-term Effect of Exercise and Self-manual Approaches to Bloating - Distention

May 27, 2024 updated by: Gulruh Karabagli, Ege University

Investigation of Short-term Effect of Exercise and Self-manual Approaches to Core Muscles Patients With Bloating - Distention

Abdominal bloating and distension (ABD) are the most commonly gastrointestinal symptoms reported by patients with various functional gut disorders such as functional dyspepsia, irritable bowel syndrome and it is frequently associated with constipation. The pathophysiology of ABD is complex, often multifactorial and poorly understood. The reseach was hypothesised that short-term self-manual approaches and exercise for core muscles would have a positive effect on the symptoms of ABD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Characteristic symptoms include recurrent abdominal fullness, pressure, or a sensation of trapped gas (abdominal bloating), and/or measurable increase in abdominal girth (abdominal distention). There are several key components in pathophysiology of ABD: a subjective sensation of abdominal bloating, objective abdominal distention, volume of intra-abdominal contents, altered pelvic floor muscle function and muscular activity of the abdominal wall. Therapeutic options include; dietary modifications, probiotics, antibiotics, prokinetic agents, antispasmodics, neuromodulators, biofeedback and physical activity. However, treatment of ABD is limited and not effective in all individuals with this symptom. There is no study investigated the effectiveness of exercise and self-manual approaches in patients with ABD. Therefore, investigators aim to determine the short-term effects and differences of exercise and self-manual approaches on symptoms in patients with ABD. Women between the ages of 18 and 75 who meet the Rome Ⅳ criteria will be diagnosed with ABD by Ege University Faculty of Medicine, Department of Gastroenterology will be included in the study. Participants will be assigned to Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) and Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles). Exercise and self-manual approaches will be performed at home 3 times a day for 8 repetitions for 4 weeks and approximately 45-60 minutes. Both groups will receive the patient education before treatment. Group 1 exercise and self-manual program include; diaphragmatic stretching technique, pectoral muscle relaxation, diaphragmatic mobilisation, thoracic mobilisation and diaphragmatic breathing. İn addition to Group 1, patients in group 2 will receive, abdominal massage, abdominal mobilisation, stabilisation exercises and pelvic floor muscle training. ABD symptoms will be assessed on a 6-point graphic rating scale (Perception of sensations), Gastrointestinal Symptom Rating Scale (GSRS), Diaphragm, abdominal wall and pelvic floor muscle and other related muscles will be assessed with Surface Electromyography (SEMG), High-Resolution Anorectal Manometry (HRAM), Balloon Expulsion Test (BET), Colon transit time (CTT) and Ultrasonography (USG).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Bornova
      • İzmir, Bornova, Turkey, 35100
        • Ege University Faculty of Medicine, Department of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females between the ages of 18 and 75
  • Diagnosed with abdominal bloating-distension according to the Rome IV criteria
  • Without any condition preventing exercise
  • Proficiency in Turkish reading and writing

Exclusion Criteria:

  • Individuals with any organic cause for bloating and distension (such as celiac disease or other absorption disorders, intestinal dysmotility, and chronic intestinal pseudo-obstruction)
  • Those with alarm symptoms (weight loss, rectal bleeding, or anemia)
  • A history of major gastrointestinal or abdomino-pelvic surgery
  • Who unable to complete the study protocol
  • Cognitively challenged to the extent that it would hinder the conduct of the study
  • Pregnant individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles)
Diaphragmatic stretching technique, pectoral muscle relaxation, diaphragmatic mobilisation, thoracic mobilisation and diaphragmatic breathing.
Other: Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles)
Both groups will receive the patient education before treatment. Diaphragmatic stretching technique, pectoral muscle relaxation, diaphragmatic mobilisation, thoracic mobilisation and diaphragmatic breathing. Exercise and self-manual approaches will be performed at home 3 times a day for 8 repetitions for 4 weeks and approximately 45-60 minutes.
Active Comparator: Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles)
İn addition to Group 1, patients in group 2 will receive, abdominal massage, abdominal mobilisation, stabilisation exercises and pelvic floor muscle training.
Other: Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles)
İn addition to Group 1, patients in group 2 will receive, abdominal massage, abdominal mobilisation, stabilisation exercises and pelvic floor muscle training. Exercise and self-manual approaches will be performed at home 3 times a day for 8 repetitions for 4 weeks and approximately 45-60 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abdominal bloating and distention (ABD) Perception of sensations
Time Frame: Pre-intervention; immediately after the Four weeks
A graded questionnaire will be used to measure the intensity and the type of sensations perceived, and an anatomical questionnaire to measure the location and extension of the perceived sensations. The graded questionnaire included four sensations: pressure, fullness, colicky sensation, and stinging sensation. Each sensation will independently scored on a graphic rating scale that combined verbal descriptors on a visual analogue scale graded from 0 to 6 (0 represent no Perception at all, score 5 represent discomfort, and score 6 represent a painful sensation). The anatomic questionnaire will be showed the abdomen divided in nine areas corresponding to epigastrium, periumbilical area, hypogastrium, both hypochondria, flanks, and ileal fossae, and the participants were instructed to mark the location, abdominal area(s) or extra-abdominal, where the sensations were perceived. Before the study, both questionnaires will be fully explained to the participants.
Pre-intervention; immediately after the Four weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Superficial Electromyography (EMG)
Time Frame: Pre-intervention; immediately after the Four weeks
A NeuroTrac MyoPlus 4 PRO (Verity Medical, UK) type EMG device will be used in the study. Bioelectrical activities of the muscles (pelvic floor muscles, abdominal muscles, diaphragm, multifidus) 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 six seconds 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.
Pre-intervention; immediately after the Four weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Pre-intervention; immediately after the Four weeks
It is a Likert-type scale with 15 items developed to assess symptoms related to gastrointestinal disorders, ranging from 'no discomfort' to 'very severe discomfort.' The scale's 15 items consist of five subscales: abdominal pain, reflux, diarrhea, indigestion, and constipation. Questions 1, 4, and 5 assess abdominal pain; questions 2 and 3 assess reflux; questions 11, 12, and 14 assess diarrhea; questions 6, 7, 8, and 9 assess indigestion; and questions 10, 13, and 15 assess constipation, and the evaluation is made accordingly. High scores obtained from the GSRS indicate more severe symptoms.
Pre-intervention; immediately after the Four weeks
High-resolution anorectal manometry (HRAM)
Time Frame: Pre-intervention; immediately after the Four weeks
To evaluate recto-anal reflex activity, anal sphincter function, recto-anal coordination during simulated defecation, and rectal sensory function will be utilized Medical Measurement Systems (MMS) device (Model- SOLAR SYSTEM, 771459). HRAM assessment will be conducted according to the London Classification. The evaluation will involve placing an air-charged (UniTip High Resolution Catheter (Unisensor)) lubricated manometry probe, equipped with pressure sensors, gently into the rectum while the patient is in the left lateral position, with the most distal sensor (1 cm level) positioned posteriorly 1 cm from the anal verge. Subsequently, approximately 3 minutes will be allotted for the patient to return to baseline anal tone. Anal resting pressure, short squeeze pressure, endurance squeeze pressure, cough reflex, push pressure, Recto-Anal İnhibitory Reflex (RAIR), rectal sensation will be evaluated.
Pre-intervention; immediately after the Four weeks
Balloon Expulsion Test (BET)
Time Frame: Pre-intervention; immediately after the Four weeks
After completing the anorectal manometry test, the Balloon Expulsion Test (BET) will be conducted by inserting an Anorectal Reflex Balloon Catheter (ADS) into the rectum, with a non-latex balloon lubricated with gel measuring 4-5 cm in length. Subsequently, the patient will be provided with privacy. While in a seated position, the balloon will be filled with 50 ml of warm water, and the patient will be asked to sit on a commode chair and expel the balloon. The patient will be instructed to start the timer, begin straining, and stop the timer when the balloon is expelled. Healthy individuals typically can expel a 50 ml balloon in less than 1 minute. Duration shorter than 2 minutes will be considered normal.
Pre-intervention; immediately after the Four weeks
Colon Transit Time (CTT)
Time Frame: Pre-intervention; immediately after the Four weeks
Colon Transit Time (CTT) will provide a quantitative assessment of colonic motor function. Participants in both groups will be instructed to ingest 10 radio-opaque ring-shaped markers (Transit-Pellets, Medifactia, Stockholm, Sweden) consecutively for 5 days each morning at 09:00. On the 6th day, they will be asked to ingest 5 stick-shaped markers at 09:00 and the remaining 5 at 21:00 (to measure rapid transit). Approximately 12 hours after the last marker intake (144 hours in total on Day 7), abdominal radiographs will be taken. The retained markers will be counted for the ascending colon, transverse colon, descending colon, sigmoid colon, and rectum. If the number of retained markers is less than 5, it will be analyzed as normal colonic transit.
Pre-intervention; immediately after the Four weeks
Ultrasonography (USG)
Time Frame: Pre-intervention; immediately after the Four weeks
The ultrasound assessment will be conducted using a Siemens X700 device equipped with a 2-dimensional, 3.5- megahertz transducer in B mode, both transabdominally and transperineally with a curvilinear probe. Prior to measurement, a standard bladder filling protocol will be employed. Measurements including diaphragm, intercostal muscles, upper and lower rectus abdominis, external and internal oblique abdominals, transversus abdominis, multifidus, erector spinae, and rectus diastasis will be recorded in millimeters (mm). Additionally, measurements of the anorectal angle and anopubic angle will be recorded in degrees (°). Measurements will be taken during inspiration, expiration, and pelvic floor contraction.
Pre-intervention; immediately after the Four weeks
Digital dynamometer
Time Frame: Pre-intervention; immediately after the Four weeks
A digital dynamometer (handheld dynamometer (HHD)) will be utilized to determine trunk flexor and extensor muscles isometric strength. Measurements will be recorded as the average of two maximum repetitions following warm-up. Results will be documented in kilograms.
Pre-intervention; immediately after the Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nuray ELİBOL, Ege University
  • Principal Investigator: Özge ÇELİKER TOSUN, Dokuz Eylül University
  • Principal Investigator: Gülruh KARABAĞLI, Ege University
  • Principal Investigator: Melahat AKTAŞ, Dokuz Eylül University
  • Principal Investigator: Serhat BOR, Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EU-FTR-GK-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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