Clinical trial NCT06473454: Patients With Irritable Bowel Syndrome and Physiotherapy
Official title: the Effect of Aerobic Exercise and Basic Body Awareness Therapy on Quality of Life and Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three goups , randomise controlled trial
Primary purpose: TREATMENT

Brief summary: The research will be planned on 72 individuals between the ages of 18-65 who were diagnosed with irritable bowel syndrome at Istanbul Medipol University Çamlıca SUAM Gastroenterology Polyclinic. Patients will be divided into 3 groups; High-intensity interval training and a disease-specific nutrition program for the first group, and a disease-specific nutrition program for the second group; Basic Body Awareness Therapy (BBAT) and a disease-specific nutrition program will be given, while the control group will be given only a disease-specific nutrition program. Evaluations will be made immediately before and after treatment. The first experimental group will be asked to walk with high-intensity interval training, which the investigators plan for 30 minutes, 4 days a week for 8 weeks. TBFT will be applied to the second experimental group every day of the week. The application will be done face to face one day a week, and the patient will be asked to do it himself on the other days, and the sessions will last approximately 30 minutes. In addition, all patients will be asked to follow the nutrition program determined by the dietician. Participants' sociodemographic information, IBS disease type and medications used will be recorded. In order to collect data for both the intervention groups and the control group immediately before and after the study; 6 Minute Walk Test (6MWT), posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities, International Physical Activity Questionnaire Short Form (IPAQ-SF), Diet Compliance Questionnaire Form, Bristol Stool Scale Form, Gastrointestinal Symptom Assessment Scale (GSDS). ), Pittsburgh Sleep Quality Index (PSQI), IBS Quality of Life Scale (IBS-QOL), Morningness-Eveningness Questionnaire (SAA), Psychological Well-Being Scale (PIOS) and Body Awareness Questionnaire (VFA) will be used.

Detailed description: Irritable bowel syndrome (IBS); It is one of the most frequently diagnosed gastrointestinal diseases, defined by the presence of altered bowel habits, abdominal pain, and discomfort in the absence of another causative disease. The research will be planned on 72 individuals between the ages of 18-65 who were diagnosed with IBS at Istanbul Medipol University Çamlıca SUAM Gastroenterology Polyclinic. Patients will be divided into 3 groups; High-intensity interval training and a disease-specific nutrition program for the first group, and a disease-specific nutrition program for the second group; Basic Body Awareness Therapy (BBAT) and a disease-specific nutrition program will be given, while the control group will be given only a disease-specific nutrition program. Evaluations will be made immediately before and after treatment. The first experimental group will be asked to walk with high-intensity interval training, which the investigators plan for 30 minutes, 4 days a week for 8 weeks. TBFT will be applied to the second experimental group every day of the week. The application will be done face to face one day a week, and the patient will be asked to do it himself on the other days, and the sessions will last approximately 30 minutes. In addition, all patients will be asked to follow the nutrition program determined by the dietician. Participants' sociodemographic information, IBS disease type and medications used will be recorded. In order to collect data for both the intervention groups and the control group immediately before and after the study; 6 Minute Walk Test (6MWT), posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities, International Physical Activity Questionnaire Short Form (IPAQ-SF), Diet Compliance Questionnaire Form, Bristol Stool Scale Form, Gastrointestinal Symptom Assessment Scale (GSDS). ), Pittsburgh Sleep Quality Index (PSQI), IBS Quality of Life Scale (IBS-QOL), Morningness-Eveningness Questionnaire (SAA), Psychological Well-Being Scale (PIOS) and Body Awareness Questionnaire (VFA) will be used. Physiotherapy and rehabilitation applications of aerobic exercise and TBFT have been rarely studied in the literature on patients with IBS; this will be the first and original study, as there are no studies examining the effects of a disease-specific nutrition program on gastrointestinal symptoms, quality of life, sleep quality and well-being.

Eligibility criteria: inclusion criterias

1. Being between the ages of 18-65 2. Compliance with Rome IV criteria 3. Declaring that you wish to participate in the study with written consent exclusion criterias

1. Voluntary refusal to participate in the study
2. Having a psychiatric illness
3. Not having any orthopedic, neurological or cardiopulmonary disease that would constitute a contraindication for the protocols to be applied.
4. Do not pose any risk of injury while working in line with posture analysis.
5. In case the limitations in muscle shortness tests prevent the study
6. Using laxatives regularly
7. Being diagnosed with diabetes or a metabolic disease that will affect the gastrointestinal system
8. No history of Inflammatory Bowel Disease (IBD), colon cancer or colon resection
9. Using antibiotics and probiotics in the last 3 months
10. Using anticholinergic, opiate or morphine-type drugs that will affect intestinal motility
11. Getting diagnosed with celiac disease

Primary outcomes:
measure: IBS Quality of Life Scale
timeFrame: pre-intervention and immediately after the intervention
measure: Gastrointestinal Symptom Assessment Scale (GSDS)
timeFrame: pre-intervention and immediately after the intervention
Secondary outcomes:
measure: posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities
timeFrame: pre-intervention and immediately after the intervention
measure: Bristol Stool Scale Form
timeFrame: pre-intervention and immediately after the intervention
measure: 6 Minute Walk Test (6MWT)
timeFrame: pre-intervention and immediately after the intervention
measure: International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: pre-intervention and immediately after the intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: pre-intervention and immediately after the intervention
measure: Body Awareness Questionnaire
timeFrame: pre-intervention and immediately after the intervention
measure: Psychological Well-Being Scale
timeFrame: pre-intervention and immediately after the intervention
measure: Morningness-Eveningness Questionnaire
timeFrame: pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol Camlica Suam Hospital
Study officials:
References: