Clinical trial NCT06347367: Short-term Effect of Exercise and Self-manual Approaches to Bloating - Distention
Official title: Investigation of Short-term Effect of Exercise and Self-manual Approaches to Core Muscles Patients With Bloating - Distention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastrointestinal System Disease
Functional Bloating
Distension; Bowel
Gastrointestinal Motility Disorder
Pelvic Floor Dyssynergia
Keywords: Functional bloating
distension
gastrointestinal motility
exercise therapy
pelvic floor
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Abdominal bloating and distention (ABD) Perception of sensations
timeFrame: Pre-intervention; immediately after the Four weeks
Secondary outcomes:
measure: Superficial Electromyography (EMG)
timeFrame: Pre-intervention; immediately after the Four weeks
Other outcomes:
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Pre-intervention; immediately after the Four weeks
measure: High-resolution anorectal manometry (HRAM)
timeFrame: Pre-intervention; immediately after the Four weeks
measure: Balloon Expulsion Test (BET)
timeFrame: Pre-intervention; immediately after the Four weeks
measure: Colon Transit Time (CTT)
timeFrame: Pre-intervention; immediately after the Four weeks
measure: Ultrasonography (USG)
timeFrame: Pre-intervention; immediately after the Four weeks
measure: Digital dynamometer
timeFrame: Pre-intervention; immediately after the Four weeks
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine, Department of Gastroenterology
state: Bornova
Study officials:
affiliation: Ege University
name: Nuray ELİBOL
role: STUDY_DIRECTOR
affiliation: Ege University
name: Gülruh KARABAĞLI
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Melahat AKTAŞ
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Özge ÇELİKER TOSUN
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Serhat BOR
role: PRINCIPAL_INVESTIGATOR
References: