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

NCT06347367 | Active Not Recruiting

• 1 other identifier: EU-FTR-GK-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Functional bloating; distension; gastrointestinal motility; exercise therapy; pelvic floor

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-intervention; immediately after the Four weeks

Secondary Outcomes (1)

• Superficial Electromyography (EMG)

  Pre-intervention; immediately after the Four weeks

Other Outcomes (6)

• Gastrointestinal Symptom Rating Scale (GSRS)

  Pre-intervention; immediately after the Four weeks

• High-resolution anorectal manometry (HRAM)

  Pre-intervention; immediately after the Four weeks

• Balloon Expulsion Test (BET)

  Pre-intervention; immediately after the Four weeks

Study Arms (2)

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.

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.

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Females between the ages of 18 and 75 who meet the Rome Ⅳ criteria will be diagnosed with ABD
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine, Department of Gastroenterology

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Digestive System Diseases; Dilatation, Pathologic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nuray ELİBOL

  Ege University

  STUDY DIRECTOR

• Gülruh KARABAĞLI

  Ege University

  PRINCIPAL INVESTIGATOR

• Melahat AKTAŞ

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Özge ÇELİKER TOSUN

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Serhat BOR

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator and Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student of physiotherapy and rehabilitation

Model Details: 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).

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: January 1, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 19, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

TU (1)