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

NCT ID: NCT06347367

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-06-19

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).

Conditions

Gastrointestinal System Disease; Functional Bloating; Distension; Bowel; Gastrointestinal Motility Disorder; Pelvic Floor Dyssynergia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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 Type: ACTIVE_COMPARATOR

Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles)

Intervention Type: 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)

İn addition to Group 1, patients in group 2 will receive, abdominal massage, abdominal mobilisation, stabilisation exercises and pelvic floor muscle training.

Group Type: ACTIVE_COMPARATOR

Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Gulruh Karabagli

Master degree student of physiotherapy and rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuray ELİBOL

Role: STUDY_DIRECTOR

Ege University

Gülruh KARABAĞLI

Role: PRINCIPAL_INVESTIGATOR

Ege University

Melahat AKTAŞ

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Özge ÇELİKER TOSUN

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Serhat BOR

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

Ege University Faculty of Medicine, Department of Gastroenterology

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EU-FTR-GK-01

Identifier Type: -

Identifier Source: org_study_id