Patients With Irritable Bowel Syndrome and Physiotherapy

September 30, 2024 updated by: Beyza Baris Erdogmus, Istanbul Saglik Bilimleri University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: aerobic exercise and basic body awareness therapy ( exercise)
exercise
Experimental: 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.
Other: aerobic exercise and basic body awareness therapy ( exercise)
exercise
No Intervention: the group of control
This group will be evaluated only before and after the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IBS Quality of Life Scale
Time Frame: pre-intervention and immediately after the intervention
It was specifically developed to evaluate the quality of life of patients diagnosed with IBS. The scale is Likert type, consisting of 34 items, 8 subgroups and 5 options (1: not at all, 2: little, 3: moderate, 4: a lot, 5: a lot). According to the options, the first statement is given 5 points and the fifth statement is given 1 point. Score calculation is made differently according to 8 subgroups in the determined direction. With this scoring system, the lowest score that can be obtained from the scale is 34 and the highest score is 170. It is thought that as the total score increases, the quality of life due to the disease also increases.
pre-intervention and immediately after the intervention
Gastrointestinal Symptom Assessment Scale (GSDS)
Time Frame: pre-intervention and immediately after the intervention
It was developed to evaluate the symptoms frequently seen in gastrointestinal system diseases. The patient is asked how he/she feels about the gastrointestinal problems he/she has encountered in the last week. On scale; abdominal pain (items 1, 4, 5), reflux (item 2, 3), indigestion (item 6, 7, 8, 9), diarrhea (item 11, 12, 14). There are five sub-dimensions consisting of items) and constipation (10th, 13th, 15th items) and consists of 15 items in total. It is in Likert type; It consists of 7 options, starting from "no discomfort" to "very severe discomfort" and the total score varies between 15 and 105. An increase in the total score indicates that the symptoms are getting worse.
pre-intervention and immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities
Time Frame: pre-intervention and immediately after the intervention
In these tests, depending on the shortness and flexibility of the muscles; Mild, moderate and severe values will be given.
pre-intervention and immediately after the intervention
Bristol Stool Scale Form
Time Frame: pre-intervention and immediately after the intervention
It is a scale that evaluates the form of the stool with shapes and provides information about intestinal health. It is widely used in the evaluation of subtypes of IBS. The scale determines the form of the stool using 7 different stool shapes. Type 1 stool indicates constipation, and Type 7 stool indicates diarrhea. Type 3-4 stool is considered the healthiest form of the intestines.
pre-intervention and immediately after the intervention
6 Minute Walk Test (6MWT)
Time Frame: pre-intervention and immediately after the intervention
The test is performed in a closed area, under the supervision of a physiotherapist, on a 30-meter-long flat surface with markings every 3 meters. Patients are informed to wear comfortable clothes and sneakers during the test and not to eat at least two hours before the test. Patients' dyspnea and fatigue are questioned during the test, before and after 6MWT; SpO2, blood pressure, heart rate, fatigue and dyspnea are evaluated. At the end of 6 minutes, the total distance walked by the patient is calculated in meters. Since most activities of daily living are performed at a submaximal level, it has been reported that 6MWT may better reflect functional exercise capacity in terms of daily physical activities.
pre-intervention and immediately after the intervention
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: pre-intervention and immediately after the intervention
International Physical Activity Survey; It is a standard questionnaire used to determine the physical activity levels of people aged 15-65 by evaluating the last 7 days. The survey consists of 4 sections, each consisting of 7 questions regarding activities lasting at least 10 minutes. Obtained points are calculated as MET - min/week. It is classified into 3 categories: inactive, minimally active and very active.
pre-intervention and immediately after the intervention
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: pre-intervention and immediately after the intervention
Buysse et al. (1989) is a scale that examines sleep quality and disturbance in the last month. PSQI sleep quality; It examines 7 subcomponents: subjective sleep quality, time to fall asleep, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping pills, and daytime dysfunction. Each component is evaluated on a scale of 0-3 points. The total score of the components determines the total score of the scale. While a total score greater than 5 indicates "poor sleep quality"; Less than 5 indicates good sleep quality
pre-intervention and immediately after the intervention
Body Awareness Questionnaire
Time Frame: pre-intervention and immediately after the intervention
It is a scale developed by Shields et al. in 1989, which evaluates body awareness in individuals and aims to determine the normal or abnormal sensitivity level of body composition. It is a Likert-type scale consisting of a total of 18 items and 4 subgroups (physiological, psychological, social and emotional awareness). Each item is scored between 1 (not at all true for me) and 7 (completely true for me). The total score is between 18 and 126, and as the score increases, it is considered that the person's body awareness level increases.
pre-intervention and immediately after the intervention
Psychological Well-Being Scale
Time Frame: pre-intervention and immediately after the intervention
It was aimed to measure psychological well-being as a complement to existing well-being measures. PIOÖ; It includes items based on having supportive and rewarding relationships, contributing to the happiness of others, social relationships, having a purposeful and meaningful life, being interested in daily activities, being engaged in a job, and feeling competent and competent in activities that are important to the person. The items are associated with optimism and self-esteem. Scale; It consists of 8 items, 7-point Likert type, and has a single factor. Scores range between 8 and 56, and higher scores indicate that the person has many psychological resources and strengths.
pre-intervention and immediately after the intervention
Morningness-Eveningness Questionnaire
Time Frame: pre-intervention and immediately after the intervention
It was developed by Horne and Östberg in 1976 to determine the chronotopy and subjective circadian rhythm of individuals. Scale; It consists of a total of 19 questions about preferred times for physical and mental activities, subjective alertness, sleep and waking times, and is in Likert type. As a result of the evaluation, scores range from 16 to 86; Those who score between 16 and 30 are defined as definitely evening people, those who score between 31 and 41 are defined as close to evening people, those who score between 42 and 58 are defined as intermediate type, those who score between 59 and 69 are defined as close to morning people, and those who score between 70 and 86 are defined as definitely morning people.
pre-intervention and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Saglik Bilimleri University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBU-BBERDOGMUS-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings