Effect of Aerobic Training Versus Relaxation Techniques on Quality of Life in Patients With Post Covid-19 Irritable Bowel Syndrome

NCT06795854 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005264
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effect of aerobic training and relaxation techniques on quality of life in Post covid-19 patients with irritable bowel syndrome .

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• IBS Severity Scoring System (IBS-SSS)

  The questionnaire consists of five questions; abdominal pain intensity, abdominal distension, life interference, bowel habit dissatisfaction and abdominal pain frequency. Each item can be scored from 0-100 (according to the value marked by the patient on the visual analog scale or the number of days multiplied by 10), thus the overall IBS severity score ranges from 0 to 500; which according to the original validation can be classified as: \< 75 healthy subjects or disease in remission; 75-175 mild disease; 175-300 moderate and \> 300 severe disease.

  6 weeks

• IBS Quality of Life (IBS-QOL)

  The questionnaire includes 34 question concerning IBS's impact on psychological, social, and daily living activities. The scale can be subdivided into subscales such as dysphoria, activity interference, avoidance of food, health worry, image of body, social, sexual, as well as relationships. Items 1, 2, 4, 8-10, 12, 13, 16, 25-29, and 34 use the following response scale (1=not at all, 2= slightly, 3=moderately, 4=quite a bit, and 5= extremely). Items 3, 5-7, 11, 14, 15, 17-24 and 30- 33 use the following response scale: (1=not at all, 2=slightly, 3=moderately, 4=quite a bit, and 5=a great deal).

  6 weeks

Secondary Outcomes (2)

• The Pittsburgh Sleep Quality Index (PSQI)

  6 weeks

• Perceived Stress Questionnaire (PSQ)

  6 weeks

Study Arms (3)

Aerobic training+ Low fodmap diet

EXPERIMENTAL

This group will include 20 patients. The participants will perform aerobic training (walking on treadmill 25-40 minutes 3 times per week) in addition they will follow a low fodmap diet three times/week for 6 weeks.

Other: Aerobic training; Other: Low fodmap diet

Relaxation techniques + Low fodmap diet

EXPERIMENTAL

This group will include 20 patients. The participants will perform the relaxation techniques in the form of mindfulness meditation and slow deep breathing in addition they will follow a low fodmap diet for 6 weeks

Other: Relaxation techniques; Other: Low fodmap diet

Low fodmap diet

ACTIVE COMPARATOR

This group will include 20 patients. The participants will receive a low fodmap diet only for 6 weeks.

Other: Low fodmap diet

Interventions

Aerobic training OTHER

Sessions will be conducted 3 times per week. Each 40-minute session will include a 5-minute warm-up involving fast walking, slow running, and stretching, followed by an active phase of continuous running. The running period will start at 15 minutes and increase by 2 minutes every two sessions until reaching 30 minutes. The session will conclude with a 5-minute cool-down of slow running and stretching. Exercise intensity will be maintained at 13-15 on the Borg Rate of Perceived Exertion, with continuous walking performed on a treadmill.

Aerobic training+ Low fodmap diet

Relaxation techniques OTHER

Relaxation techniques will include slow deep breathing and mindfulness meditation exercises. The breathing exercise will involve six cycles per minute, with a 4-second inhalation and a 6-second exhalation, repeated for 30 minutes, three sessions per week. Mindfulness meditation will include a stress and pain management program with sessions starting at 10-15 minutes and gradually increasing to 20-30 minutes, three times per week. Sessions will be conducted in a quiet, comfortable space, focusing on breath awareness, body scanning, thought observation, and optional loving-kindness meditation, concluding with a reflection period.

Relaxation techniques + Low fodmap diet

Low fodmap diet OTHER

All groups will follow a low-FODMAP diet (LFD). The LFD will exclude foods that commonly aggravate IBS symptoms, such as those containing lactose (dairy), fructose (e.g., apples, pears), and sweeteners like sorbitol and xylitol. Female participants with a BMI of 25 to 29 will aim for a daily calorie intake of 1,800 to 2,200 calories, adjusted based on age, activity level, and metabolism, to maintain weight while managing IBS symptoms effectively.

Aerobic training+ Low fodmap diet; Low fodmap diet; Relaxation techniques + Low fodmap diet

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index range from 25 to 29.9 kg/m2.
• Patients meeting the Rome IV diagnostic criteria for IBS, it is characterized by the presence of recurrent abdominal pain, on average, at least 1 day a week in the last 3 months with onset of symptoms at least 6 months before diagnosis, associated with 2 or more factors: related to defecation and/or associated with change in stool frequency and/or associated with change in stool form.
• Clinically and medically stable.
• Baseline IBS-SSS score from 75 to 299(mild and moderate).
• No medication for IBS (except for emergencies) within at least 2 weeks ago.
• All patients are not following any type of diet protocol within 3 months prior to the treatment.

You may not qualify if:

• The patient has a history of rheumatic diseases in the lower limb.
• Having a history of metabolic, neurologic, cardiovascular, respiratory, renal, and lung problems which would prevent them from participating in aerobic exercises.
• Having a history of knee injury or knee surgery during the past year
• Having a history of fracture in the lower limb during the past six months
• Major vision disorders.
• Hereditary or acquired musculoskeletal disorders in the lower limb.
• Organic gastrointestinal disorders.
• Using drugs that would affect metabolism
• Intestinal organic diseases or systemic diseases affecting gastrointestinal motility (such as gallbladder pancreatitis, hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases).
• History of abdominal or rectal anus surgery.
• Pregnancy or breastfeeding, and post-partum 12 months
• Patient undergoes chemotherapy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Relaxation Therapy; FODMAP Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hany Ezzat Obaya, PhD

  Assistant Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Alae Ahmed Salem Ismail, M.Sc

CONTACT

+20 10 03242511; alaeahmedsalemismail@gmail.com

Rana Hesham Mohamed Elbanna, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 15, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

EG (1)