Irritable Bowel SyndromeNCT06473454
Patients With Irritable Bowel Syndrome and Physiotherapy
A study testing aerobic exercise and basic body awareness therapy ( exercise) in people with Irritable Bowel Syndrome, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- aerobic exercise and basic body awareness therapy ( exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Voluntary refusal to participate in the study
- Having a psychiatric illness
- Not having any orthopedic, neurological or cardiopulmonary disease that would constitute a contraindication for the protocols to be applied.
- Do not pose any risk of injury while working in line with posture analysis.
- In case the limitations in muscle shortness tests prevent the study
Show all 12Show fewer
- Using laxatives regularly
- Being diagnosed with diabetes or a metabolic disease that will affect the gastrointestinal system
- No history of Inflammatory Bowel Disease (IBD), colon cancer or colon resection
- Using antibiotics and probiotics in the last 3 months
- Using anticholinergic, opiate or morphine-type drugs that will affect intestinal motility
- Getting diagnosed with celiac disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol Camlica Suam Hospital
Istanbul
BULENT YASAR, PROF, +90 216 681 3030, bulent.yasar@medipol.com.tr
About this study
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
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.
Read the 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
- Being tested
- aerobic exercise and basic body awareness therapy ( exercise)
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise and basic body awareness therapy ( exercise)Other
exercise
| Study group | Role | What they receive |
|---|---|---|
| the group of aerobic exercise | Experimental | This group will walk 4 days a week along with high-intensity interval training. Evaluations will be made before and after. Receives: Other: aerobic exercise and basic body awareness therapy ( exercise) |
| the group of basic body awareness therapy | Experimental | 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. Receives: Other: aerobic exercise and basic body awareness therapy ( exercise) |
| the group of control | No intervention | This group will be evaluated only before and after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Quality of Life Scale
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.
Measured: pre-intervention and immediately after the intervention
Gastrointestinal Symptom Assessment Scale (GSDS)
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.
Measured: pre-intervention and immediately after the intervention
Secondary outcomes (8)
posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities
In these tests, depending on the shortness and flexibility of the muscles; Mild, moderate and severe values will be given.
Measured: pre-intervention and immediately after the intervention
Bristol Stool Scale Form
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.
Measured: pre-intervention and immediately after the intervention
6 Minute Walk Test (6MWT)
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.
Measured: pre-intervention and immediately after the intervention
International Physical Activity Questionnaire Short Form (IPAQ-SF)
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.
Measured: pre-intervention and immediately after the intervention
Pittsburgh Sleep Quality Index (PSQI)
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
Measured: pre-intervention and immediately after the intervention
Body Awareness Questionnaire
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.
Measured: pre-intervention and immediately after the intervention
Psychological Well-Being Scale
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.
Measured: pre-intervention and immediately after the intervention
Morningness-Eveningness Questionnaire
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.
Measured: pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start20 Jul 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three goups , randomise controlled trial
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Baris Erdogmus, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473454
- Sponsor's protocol ID
- SBU-BBERDOGMUS-001
- Status last verified
- Sep 2024
- First submitted
- 8 May 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06473454
- Acronym / sponsor ID
- SBU-BBERDOGMUS-001
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- three goups , randomise controlled trial
| Arm | Type | Receives |
|---|---|---|
| the group of aerobic exercise | Experimental | Other: aerobic exercise and basic body awareness therapy ( exercise)This group will walk 4 days a week along with high-intensity interval training. Evaluations will be made before and after. |
| the group of basic body awareness therapy | Experimental | Other: aerobic exercise and basic body awareness therapy ( exercise)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. |
| the group of control | No intervention | –This group will be evaluated only before and after the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Voluntary refusal to participate in the study
- Having a psychiatric illness
- Not having any orthopedic, neurological or cardiopulmonary disease that would constitute a contraindication for the protocols to be applied.
- Do not pose any risk of injury while working in line with posture analysis.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise and basic body awareness therapy ( exercise)exercise | Other | the group of aerobic exercise, the group of basic body awareness therapy |
Primary outcome
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.
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.
8 secondary outcomes
posture analysis, muscle shortness test for large muscle groups in the lower and upper extremities
Time frame: pre-intervention and immediately after the intervention
Bristol Stool Scale Form
Time frame: pre-intervention and immediately after the intervention
6 Minute Walk Test (6MWT)
Time frame: pre-intervention and immediately after the intervention
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: pre-intervention and immediately after the intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: pre-intervention and immediately after the intervention
Body Awareness Questionnaire
Time frame: pre-intervention and immediately after the intervention
Psychological Well-Being Scale
Time frame: pre-intervention and immediately after the intervention
Morningness-Eveningness Questionnaire
Time frame: pre-intervention and immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and basic body awareness therapy ( exercise) in people with Irritable Bowel Syndrome, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS Quality of Life Scale (time frame: pre-intervention and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.