Gastrointestinal Motility Disorder Clinical Trial
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | April 19, 2024 |
Est. primary completion date | April 17, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University Faculty of Medicine, Department of Gastroenterology | Izmir | Bornova |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gastrointestinal Symptom Rating Scale (GSRS) | It is a Likert-type scale with 15 items developed to assess symptoms related to gastrointestinal disorders, ranging from 'no discomfort' to 'very severe discomfort.' The scale's 15 items consist of five subscales: abdominal pain, reflux, diarrhea, indigestion, and constipation. Questions 1, 4, and 5 assess abdominal pain; questions 2 and 3 assess reflux; questions 11, 12, and 14 assess diarrhea; questions 6, 7, 8, and 9 assess indigestion; and questions 10, 13, and 15 assess constipation, and the evaluation is made accordingly. High scores obtained from the GSRS indicate more severe symptoms. | Pre-intervention; immediately after the Four weeks | |
Other | High-resolution anorectal manometry (HRAM) | To evaluate recto-anal reflex activity, anal sphincter function, recto-anal coordination during simulated defecation, and rectal sensory function will be utilized Medical Measurement Systems (MMS) device (Model- SOLAR SYSTEM, 771459). HRAM assessment will be conducted according to the London Classification. The evaluation will involve placing an air-charged (UniTip High Resolution Catheter (Unisensor)) lubricated manometry probe, equipped with pressure sensors, gently into the rectum while the patient is in the left lateral position, with the most distal sensor (1 cm level) positioned posteriorly 1 cm from the anal verge. Subsequently, approximately 3 minutes will be allotted for the patient to return to baseline anal tone. Anal resting pressure, short squeeze pressure, endurance squeeze pressure, cough reflex, push pressure, Recto-Anal Inhibitory Reflex (RAIR), rectal sensation will be evaluated. | Pre-intervention; immediately after the Four weeks | |
Other | Balloon Expulsion Test (BET) | After completing the anorectal manometry test, the Balloon Expulsion Test (BET) will be conducted by inserting an Anorectal Reflex Balloon Catheter (ADS) into the rectum, with a non-latex balloon lubricated with gel measuring 4-5 cm in length. Subsequently, the patient will be provided with privacy. While in a seated position, the balloon will be filled with 50 ml of warm water, and the patient will be asked to sit on a commode chair and expel the balloon. The patient will be instructed to start the timer, begin straining, and stop the timer when the balloon is expelled. Healthy individuals typically can expel a 50 ml balloon in less than 1 minute. Duration shorter than 2 minutes will be considered normal. | Pre-intervention; immediately after the Four weeks | |
Other | Colon Transit Time (CTT) | Colon Transit Time (CTT) will provide a quantitative assessment of colonic motor function. Participants in both groups will be instructed to ingest 10 radio-opaque ring-shaped markers (Transit-Pellets, Medifactia, Stockholm, Sweden) consecutively for 5 days each morning at 09:00. On the 6th day, they will be asked to ingest 5 stick-shaped markers at 09:00 and the remaining 5 at 21:00 (to measure rapid transit). Approximately 12 hours after the last marker intake (144 hours in total on Day 7), abdominal radiographs will be taken. The retained markers will be counted for the ascending colon, transverse colon, descending colon, sigmoid colon, and rectum. If the number of retained markers is less than 5, it will be analyzed as normal colonic transit. | Pre-intervention; immediately after the Four weeks | |
Other | Ultrasonography (USG) | The ultrasound assessment will be conducted using a Siemens X700 device equipped with a 2-dimensional, 3.5- megahertz transducer in B mode, both transabdominally and transperineally with a curvilinear probe. Prior to measurement, a standard bladder filling protocol will be employed. Measurements including diaphragm, intercostal muscles, upper and lower rectus abdominis, external and internal oblique abdominals, transversus abdominis, multifidus, erector spinae, and rectus diastasis will be recorded in millimeters (mm). Additionally, measurements of the anorectal angle and anopubic angle will be recorded in degrees (°). Measurements will be taken during inspiration, expiration, and pelvic floor contraction. | Pre-intervention; immediately after the Four weeks | |
Other | Digital dynamometer | A digital dynamometer (handheld dynamometer (HHD)) will be utilized to determine trunk flexor and extensor muscles isometric strength. Measurements will be recorded as the average of two maximum repetitions following warm-up. Results will be documented in kilograms. | Pre-intervention; immediately after the Four weeks | |
Primary | Abdominal bloating and distention (ABD) Perception of sensations | We will use a graded questionnaire 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 | 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. | Pre-intervention; immediately after the Four weeks |
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