Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-29
Brief Title:
Short-term Effect of Exercise and Self-manual Approaches to Bloating - Distention
Sponsor:
Ege University
Organization:
Ege University
Study Overview
Official Title:
Investigation of Short-term Effect of Exercise and Self-manual Approaches to Core Muscles Patients With Bloating - Distention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None