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NCT Number: NCT07760298

Calisthenics Versus Cycling Exercises on Interleukin-6 and Quality of Life in Benha University Students With Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • organic gastro -intestinal disorders
  • thyroid dysfunctions
  • concurrent cardio vascular?
  • respiratory, renal, hepatic disorders
  • neurological/musculoskeletal problems,
  • psychiatric disease,
  • hematological disease,
  • previous history of stomach or intestinal excision.
  • BMI will be >30 kg\\m2
  • Participating in any other ex progrm

Treatment and study plan

calisthenics exercises

Other

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 exercises

Other

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 advices

Other

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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

  4. 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.

Secondary outcomes

  1. aerobic capacity

    Time frame: up to eight weeks

    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

  2. Academic achievement

    Time frame: up to eight weeks

    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

  3. sleep disability

    Time frame: up to eight weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

heba gamal, master

CONTACT

[email protected]

20 12 79657700

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: IBS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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