Irritable Bowel SyndromeIBSNCT07760298
Calisthenics Versus Cycling Exercises on Interleukin-6 and Quality of Life in Benha University Students With Irritable Bowel Syndrome
A study testing Calisthenics exercises, Cycling Exercises and diet advices in people with Irritable Bowel Syndrome, run by Cairo University.
Trial summary
this study will be conducted to compare between the effect of calisthenics versus cycling exercises on interleukin-6 and quality of life in Benha University students with irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Calisthenics exercises, Cycling Exercises and diet advices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 20 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- females will be aged from 18 to 25 years old
- diagnosis by Rome IV diagnostic criteria
- BMI will be 18.5- 29.5 kg\m2
- (Moderate-severe) severity of IBS.
Who cannot join
- organic gastro -intestinal disorders
- thyroid dysfunctions
- concurrent cardio vascular?
- respiratory, renal, hepatic disorders
- neurological/musculoskeletal problems,
- psychiatric disease,
Show all 10Show fewer
- hematological disease,
- previous history of stomach or intestinal excision.
- BMI will be >30 kg\m2
- Participating in any other ex progrm
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study will be conducted to compare between the effect of calisthenics versus cycling exercises on interleukin-6 and quality of life in Benha University students with irritable bowel syndrome.
Read the detailed description
Irritable bowel syndrome (IBS) is one of the most common chronic gastro-intestinal disorders affecting up to 20 % of the population all over the world and affecting approximately 9-22% of the European adult population and affecting female more than male.Irritable bowel syndrome (IBS) is one of the most common functional bowel disorders, and has substantial implications for the lives of patients, as well as a huge economic impact on society. The high prevalence of Irritable bowel syndrome (IBS) is associated with a marked reduction in health-related quality of life, higher rates of somatisation, increased likelihood of psychological comorbidity, including depression and suicidal ideation, and work impairment, as well as greater medical and prescription medicine costs per year .Students, especially those who are undergraduates, are highly liable to IBS that is linked to increased stresses as exams and because they always rely on fast foods for their diet. Similarly, dietary pattern has significant negative effect on IBS. IBS can affect the academic performance of the studying students.Physical exercises help people with IBS by increasing the motility of the stomach and encouraging regular bowel movements, lowering stress and anxiety by releasing endorphins, and strengthening the gut microbiota to reduce inflammation and improve barrier function. Additionally, using bodyweight activities can help people with IBS improve their overall quality of life by reducing bloating and improving gas evacuation
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Calisthenics exercises, Cycling Exercises, diet advices
- Keywords
- Calisthenics, Cycling Exercises, Interleukin-6, Quality of Life, Benha University Students With Irritable Bowel Syndrome
- 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.
Calisthenics exercisesOther
The training regimen included stretching, calisthenic exercises (25 minutes), cooling down, and warming up (10 min) every patient will perform one to three sets of eight exercise stations (crunches, push-ups, planks, front leg raises, upper back extensions, bicycle crunches, squats, and lunges).
With a 10-second break in between stations, each exercise (exercise training) was done for 20 seconds. One set of callisthenic exercises lasted four minutes. The workout intensity was determined by the number of sets, repetitions, and rest interval. With the progression of exercises, week by week, the exercise training's intensity will increase, plus diet advices.
Cycling ExercisesOther
the patients will perform moderate-intensity aerobic exercise by (stationary bicycling) three times a week for eight weeks.
First, Intensity: the intensity of the exercise was 60-75% of HRmax; it was monitored using a maximum heart-rate monitor and customized using Tanaka's formula. Tanaka method is a formula to estimate a person's maximum heart rate (HRmax) based on their age, using the equation (HR_{max}=208-(0.7× {age}).Then the participants will do aerobic exercise with a slow speed for 5 min to warm up. After that, they will increase their speed until they reach the target heart rate and maintain it for 20 min. Finally, they will do exercise for 5 min with a slow speed to cool down plus diet advice.
diet advicesOther
the diet advices include:
- Integrating a healthier eating habit, having food at the same time every day with regular intervals
- Never eat too little or too much.
- Staying properly hydrated
- Preventing processed, fatty, and spicy food
- Limiting caffeine, carbonated, and alcoholic drinks
- Limiting fiber intake to soluble fibers starts with a low dose and builds up gradually.
- Avoiding insoluble fibers, gas-producing foods like beans, and sweeteners
- Awareness of dietary intolerance
- additional advice for increasing physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Calisthenics exercises | Experimental | Twenty patients with IBS will be trained by calisthenics exercises, 3 times per week for 2 months with diet advices. Receives: Other: Calisthenics exercises; Other: diet advices |
| Cycling Exercises | Experimental | Twenty patients with IBS will be trained by cycling exercises, 3 times per week for 2 months, with diet advices. Receives: Other: Cycling Exercises; Other: diet advices |
| diet advices | Active comparator | Twenty patients with IBS will diet advices for 2 months Receives: Other: diet advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6)
Interleukin-6 (IL-6) is measured using methods such as ELISA kits . ELISA kits are widely used, providing reliable, sensitive, and specific measurements.The normal range for Interleukin-6 (IL-6) in healthy adults is typically less than 5 to 7 picograms per milliliter (pg/mL).
Measured: up to eight weeks
Irritable Bowel Syndrome Severity
Irritable Bowel Syndrome Severity Scoring System will be used to assess bowel severity through five clinically significant items over ten days, as follows: frequency ,severity of abdominal pain , degree of abdominal distention or tightness, dissatisfaction with bowel habits, affection of IBS on quality of life.
A greater score denotes worse conditions. Each item is rated on a visual analog scale (VAS) from 0 to 100, resulting in an overall score ranging from 0 to 500. Based on the data collected, the IBS-SSS scores are divided into three categories: mild symptoms (from 75 to 174), moderate symptoms (from 175 to 299), and severe symptoms (from 300 to 500) Additionally, a 95-point reduction in total IBS-SSS scores is clinically meaningful, indicating an improvement in symptoms.
Measured: up to eight weeks
Frequency of complete spontaneous bowel movements
Defined as a sense of complete evacuation without laxatives, enemas, or suppositories on the day of the bowel movement or the preceding day. A participant with a weekly complete spontaneous bowel movement frequency rate of three or more and an increase of one or more from baseline is considered a responder. The patients reported the number of their complete spontaneous bowel movements per week at baseline and post-intervention
Measured: up to eight weeks
life disability
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Instrument will be used to assess life disability.A 34-item, patient-reported questionnaire used to assess the health-related quality of life (HRQOL) and the impact of IBS and its treatments on patients' lives. The questionnaire covers eight domains:
dysphoria, interference with activity, body image, health worry, food avoidance, social reactions, sexual concerns, and relationships. Responses are given on a 5-point Likert scale, with scores summed and transformed to a 0-100 scale, where higher scores indicate a better quality of life.
Measured: up to eight weeks
Secondary outcomes (3)
aerobic capacity
6 min walk test (6 MWT) : To assess aerobic capacity and endurance, a submaximal exercise test will used. The distance travelled in 6 minutes will used as the outcome to compare changes in performance capacity. The 6 MWT should ideally will be done indoors on a hard-surfaced, straight, and flat corridor that is at least 30 meters long. The patient will instructed to dress and walk comfortably
Measured: up to eight weeks
Academic achievement
Academic achievement will be measured by Academic Achievement Questionnaire (AAQ).The AAQ is a concise tool for measuring three aspects of academic achievement: study performance, handling of study demands, and social adaptation . The first study with a pilot version of AAQ confirmed the three-factor structure using an exploratory factor analysis and specified 9 items for the final version of questionnaire.Higher total = better academic performance
Measured: up to eight weeks
sleep disability
The Pittsburgh Sleep Quality Index (PSQI) uses 19 self-rated questions to yield seven clinical component scores. Each component is scored from 0 (no difficulty) to 3 (severe difficulty). These seven scores are added together to create a global score from 0 to 21, where a total score above 5 indicates significant sleep trouble.
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Calisthenics and Cycling Exercises
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Gamal Ali Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760298
- Sponsor's protocol ID
- P.T.REC/012/006436
- Acronym
- IBS
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calisthenics Versus Cycling Exercises on Interleukin-6 and Quality of Life in Benha University Students With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07760298
- Acronym / sponsor ID
- IBS / P.T.REC/012/006436
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Calisthenics, Cycling Exercises, Interleukin-6, Quality of Life, Benha University Students With Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 12 Aug 2026 (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.
this study will be conducted to compare between the effect of calisthenics versus cycling exercises on interleukin-6 and quality of life in Benha University students with irritable bowel syndrome.
Detailed description
Irritable bowel syndrome (IBS) is one of the most common chronic gastro-intestinal disorders affecting up to 20 % of the population all over the world and affecting approximately 9-22% of the European adult population and affecting female more than male.Irritable bowel syndrome (IBS) is one of the most common functional bowel disorders, and has substantial implications for the lives of patients, as well as a huge economic impact on society. The high prevalence of Irritable bowel syndrome (IBS) is associated with a marked reduction in health-related quality of life, higher rates of somatisation, increased likelihood of psychological comorbidity, including depression and suicidal ideation, and work impairment, as well as greater medical and prescription medicine costs per year .Students, especially those who are undergraduates, are highly liable to IBS that is linked to increased stresses as exams and because they always rely on fast foods for their diet. Similarly, dietary pattern has significant negative effect on IBS. IBS can affect the academic performance of the studying students.Physical exercises help people with IBS by increasing the motility of the stomach and encouraging regular bowel movements, lowering stress and anxiety by releasing endorphins, and strengthening the gut microbiota to reduce inflammation and improve barrier function. Additionally, using bodyweight activities can help people with IBS improve their overall quality of life by reducing bloating and improving gas evacuation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Calisthenics and Cycling Exercises
| Arm | Type | Receives |
|---|---|---|
| Calisthenics exercises | Experimental | Other: Calisthenics exercises, Other: diet advicesTwenty patients with IBS will be trained by calisthenics exercises, 3 times per week for 2 months with diet advices. |
| Cycling Exercises | Experimental | Other: Cycling Exercises, Other: diet advicesTwenty patients with IBS will be trained by cycling exercises, 3 times per week for 2 months, with diet advices. |
| diet advices | Active comparator | Other: diet advicesTwenty patients with IBS will diet advices for 2 months |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- females will be aged from 18 to 25 years old
- diagnosis by Rome IV diagnostic criteria
- BMI will be 18.5- 29.5 kg\m2
- (Moderate-severe) severity of IBS.
Key exclusion criteria (10 listed)
- organic gastro -intestinal disorders
- thyroid dysfunctions
- concurrent cardio vascular?
- respiratory, renal, hepatic disorders
- neurological/musculoskeletal problems,
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 |
|---|---|---|
| Calisthenics exercisesThe training regimen included stretching, calisthenic exercises (25 minutes), cooling down, and warming up (10 min) every patient will perform one to three sets of eight exercise stations (crunches, push-ups, planks, front leg raises, upper back extensions, bicycle crunches, squats, and lunges). With a 10-second break in between stations, each exercise (exercise training) was done for 20 seconds. One set of callisthenic exercises lasted four minutes. The workout intensity was determined by the number of sets, repetitions, and rest interval. With the progression of exercises, week by week, the exercise training's intensity will increase, plus diet advices. | Other | Calisthenics exercises |
| Cycling Exercisesthe patients will perform moderate-intensity aerobic exercise by (stationary bicycling) three times a week for eight weeks. First, Intensity: the intensity of the exercise was 60-75% of HRmax; it was monitored using a maximum heart-rate monitor and customized using Tanaka's formula. Tanaka method is a formula to estimate a person's maximum heart rate (HRmax) based on their age, using the equation (HR_{max}=208-(0.7× {age}).Then the participants will do aerobic exercise with a slow speed for 5 min to warm up. After that, they will increase their speed until they reach the target heart rate and maintain it for 20 min. Finally, they will do exercise for 5 min with a slow speed to cool down plus diet advice. | Other | Cycling Exercises |
| diet advicesthe diet advices include: 1. Integrating a healthier eating habit, having food at the same time every day with regular intervals 2. Never eat too little or too much. 3. Staying properly hydrated 4. Preventing processed, fatty, and spicy food 5. Limiting caffeine, carbonated, and alcoholic drinks 6. Limiting fiber intake to soluble fibers starts with a low dose and builds up gradually. 7. Avoiding insoluble fibers, gas-producing foods like beans, and sweeteners 8. Awareness of dietary intolerance 9. additional advice for increasing physical activity. | Other | Calisthenics exercises, Cycling Exercises, diet advices |
Primary outcome
Interleukin-6 (IL-6)
Time frame: up to eight weeks
Interleukin-6 (IL-6) is measured using methods such as ELISA kits . ELISA kits are widely used, providing reliable, sensitive, and specific measurements.The normal range for Interleukin-6 (IL-6) in healthy adults is typically less than 5 to 7 picograms per milliliter (pg/mL).
Irritable Bowel Syndrome Severity
Time frame: up to eight weeks
Irritable Bowel Syndrome Severity Scoring System will be used to assess bowel severity through five clinically significant items over ten days, as follows: frequency ,severity of abdominal pain , degree of abdominal distention or tightness, dissatisfaction with bowel habits, affection of IBS on quality of life. A greater score denotes worse conditions. Each item is rated on a visual analog scale (VAS) from 0 to 100, resulting in an overall score ranging from 0 to 500. Based on the data collected, the IBS-SSS scores are divided into three categories: mild symptoms (from 75 to 174), moderate symptoms (from 175 to 299), and severe symptoms (from 300 to 500) Additionally, a 95-point reduction in total IBS-SSS scores is clinically meaningful, indicating an improvement in symptoms.
Frequency of complete spontaneous bowel movements
Time frame: up to eight weeks
Defined as a sense of complete evacuation without laxatives, enemas, or suppositories on the day of the bowel movement or the preceding day. A participant with a weekly complete spontaneous bowel movement frequency rate of three or more and an increase of one or more from baseline is considered a responder. The patients reported the number of their complete spontaneous bowel movements per week at baseline and post-intervention
life disability
Time frame: up to eight weeks
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Instrument will be used to assess life disability.A 34-item, patient-reported questionnaire used to assess the health-related quality of life (HRQOL) and the impact of IBS and its treatments on patients' lives. The questionnaire covers eight domains: dysphoria, interference with activity, body image, health worry, food avoidance, social reactions, sexual concerns, and relationships. Responses are given on a 5-point Likert scale, with scores summed and transformed to a 0-100 scale, where higher scores indicate a better quality of life.
3 secondary outcomes
aerobic capacity
Time frame: up to eight weeks
Academic achievement
Time frame: up to eight weeks
sleep disability
Time frame: up to eight weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Calisthenics exercises, Cycling Exercises and diet advices in people with Irritable Bowel Syndrome, run by Cairo University.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact heba gamal, master (20 12 79657700, heba.gamal@fpt.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (IL-6) (time frame: up to eight weeks). The study lists 4 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 12 Aug 2026.