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

NCT07760298 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006436
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

Calisthenics; Cycling Exercises; Interleukin-6; Quality of Life; Benha University Students With Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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

  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.

  up to eight weeks

Secondary Outcomes (3)

• aerobic capacity

  up to eight weeks

• Academic achievement

  up to eight weeks

• sleep disability

  up to eight weeks

Study Arms (3)

Calisthenics exercises

EXPERIMENTAL

Twenty patients with IBS will be trained by calisthenics exercises, 3 times per week for 2 months with diet advices.

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.

Other: Cycling Exercises; Other: diet advices

diet advices

ACTIVE COMPARATOR

Twenty patients with IBS will diet advices for 2 months

Other: diet advices

Interventions

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.

Calisthenics exercises

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.

Cycling Exercises

diet advices OTHER

the 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.

Calisthenics exercises; Cycling Exercises; diet advices

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: females with irritable bowel syndrome with aged from 18 to 25 years old will be included in this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

heba gamal, master

CONTACT

20 12 79657700; heba.gamal@fpt.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: opaque sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator : heba gamal ali ali

Model Details: Calisthenics and Cycling Exercises

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08