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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-25
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

organic gastro -intestinal disorders

thyroid dysfunctions

concurrent cardio vascular?

respiratory, renal, hepatic disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calisthenics exercises

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Calisthenics exercisesExperimental treatment 2 interventions
Group B: Cycling ExercisesExperimental treatment 2 interventions
Group C: diet advicesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
up to eight weeks
2

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.

Time frame
up to eight weeks
3

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

Time frame
up to eight weeks
4

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.

Time frame
up to eight weeks

Secondary outcomes

1

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

Time frame
up to eight weeks
2

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

Time frame
up to eight weeks
3

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.

Time frame
up to eight weeks

Other outcomes

Locations

This trial has no locations.

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