Gastrointestinal System DiseaseNCT06347367
Short-term Effect of Exercise and Self-manual Approaches to Bloating - Distention
A study testing 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) in people with Gastrointestinal System Disease and Functional Bloating, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Gastrointestinal System Disease, Functional Bloating, Distension; Bowel
- What is being tested?
- 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)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 19 Jun 2024
- Phase
- Interventional
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine, Department of Gastroenterology
Izmir, Bornova, 35100
About this study
Official title: 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.
Read the 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).
- Conditions
- Gastrointestinal System Disease, Functional Bloating, Distension; Bowel, Gastrointestinal Motility Disorder, Pelvic Floor Dyssynergia
- Being tested
- Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles), Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles)
- Keywords
- Functional bloating, distension, gastrointestinal motility, exercise therapy, pelvic floor
- Medical subject headings
- Digestive System Diseases, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles)Other
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.
Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) | Active comparator | Diaphragmatic stretching technique, pectoral muscle relaxation, diaphragmatic mobilisation, thoracic mobilisation and diaphragmatic breathing. Receives: Other: Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) |
| Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles) | Active comparator | İn addition to Group 1, patients in group 2 will receive, abdominal massage, abdominal mobilisation, stabilisation exercises and pelvic floor muscle training. Receives: Other: Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal bloating and distention (ABD) Perception of sensations
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.
Measured: Pre-intervention; immediately after the Four weeks
Secondary outcomes (1)
Superficial Electromyography (EMG)
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.
Measured: Pre-intervention; immediately after the Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jan 2023
- Primary completion17 Jun 2024 (estimated)
- Study completion19 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal System DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulruh Karabagli, Ege University
- Investigators
- Nuray ELİBOL, Study director, Ege UniversityGülruh KARABAĞLI, Principal investigator, Ege UniversityMelahat AKTAŞ, Principal investigator, Dokuz Eylul UniversityÖzge ÇELİKER TOSUN, Principal investigator, Dokuz Eylul UniversitySerhat BOR, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347367
- Sponsor's protocol ID
- EU-FTR-GK-01
- Status last verified
- May 2024
- First submitted
- 29 Mar 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Short-term Effect of Exercise and Self-manual Approaches to Core Muscles Patients With Bloating - Distention
- ClinicalTrials.gov ID
- NCT06347367
- Acronym / sponsor ID
- EU-FTR-GK-01
- Conditions
- Gastrointestinal System Disease, Functional Bloating, Distension; Bowel, Gastrointestinal Motility Disorder, Pelvic Floor Dyssynergia
- Keywords
- Functional bloating, distension, gastrointestinal motility, exercise therapy, pelvic floor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 17 Jun 2024 (estimated)
- Study completion
- 19 Jun 2024 (estimated)
- First posted
- 4 Apr 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) | Active comparator | Other: 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. |
| Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) |
| 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. | Other | Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles) |
Primary outcome
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.
1 secondary outcome
Superficial Electromyography (EMG)
Time frame: Pre-intervention; immediately after the Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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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.
Nuray ELİBOL study director
Ege University
Gülruh KARABAĞLI principal investigator
Ege University
Melahat AKTAŞ principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) in people with Gastrointestinal System Disease and Functional Bloating, run by Ege 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 May 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?
Results are not available in the source record.
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?
Abdominal bloating and distention (ABD) Perception of sensations (time frame: Pre-intervention; immediately after the Four weeks). 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 29 May 2024.