Patients With Irritable Bowel Syndrome and Physiotherapy

NCT ID: NCT06473454

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2025-02-15

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the group of aerobic exercise

This group will walk 4 days a week along with high-intensity interval training. Evaluations will be made before and after.

Group Type: EXPERIMENTAL

aerobic exercise and basic body awareness therapy ( exercise)

Intervention Type: OTHER

exercise

the group of basic body awareness therapy

This group will do basic body awareness exercises once a week, accompanied by a physiotherapist, and on the other days they will do it themselves. Evaluations will be made before and after.

Group Type: EXPERIMENTAL

aerobic exercise and basic body awareness therapy ( exercise)

Intervention Type: OTHER

exercise

the group of control

This group will be evaluated only before and after the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

aerobic exercise and basic body awareness therapy ( exercise)

exercise

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role: lead

Responsible Party

Beyza Baris Erdogmus

physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medipol Camlica Suam Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

BULENT YASAR, PROF

Role: primary

bulent.yasar@medipol.com.tr

+90 216 681 3030

Other Identifiers

SBU-BBERDOGMUS-001

Identifier Type: -

Identifier Source: org_study_id