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

NCT ID: NCT06795854

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-05-15

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 .

Detailed Description

GI symptoms during active COVID-19 infection increase the chances of developing post-COVID-19 IBS. The risk of developing post-COVID-19 IBS increases in female patients.

The COVID-19 outbreak has caused significant global concern and presents a major challenge for healthcare professionals and public health authorities. Gastrointestinal symptoms are observed in (11-61%) of COVID-19 patients, varying in onset and severity. GI epithelial cells express ACE-2, the primary receptor for SARS-CoV-2.

COVID-19 impacts IBS pathophysiology by disturbing gut microbes. The gut-lung axis, influenced by immune system molecules, often links GI and respiratory disorders.

Post-SARS-CoV-2 infection, IBS prevalence varies by region and study type. In Europe, it's 31%, in North America 16%, and in Asia 7%. A multinational study found a 3% prevalence, cross-sectional studies showed 13%, and longitudinal studies reported 16%.

IBS affects 10-25% of the global population and is a common reason for primary healthcare visits. In the US alone, 2.4-3.5 million people seek medical help yearly for IBS. Recent studies across 38 countries with 395,385 participants reported a 9.2% prevalence. In Western nations, it's 10-18%, while non-Western countries show less attention, with prevalence reaching 35-43% in some developing nations. IBS tends to affect younger individuals more.

IBS is the condition with the highest prevalence among gastrointestinal functional diseases (between 7-10% of the general population, globally).

Prevalence of irritable bowel syndrome by Rome IV. Prevalence of an Internet survey conducted by the Rome Foundation in multiple centers worldwide based on Rome IV. Asia, 1.3%-4.7%; Europe, 3.5%-5.9%; America, 3.5%-5.3%; Australia, 3.5%; Egypt, 7.6%; and South Africa, 5.9%.

IBS prevalence is higher in low- and middle-income countries, particularly among Africans. It increases in the fourth decade by 32.1% and in the fifth decade by 31.1%. Besides known risk factors like female sex, smoking, and stress, previous COVID-19 infection is now recognized as a risk factor. Modifiable risk factors include abnormal BMI, smoking, rich diets, caffeine intake, and low physical activity.

The rising disease rates, particularly in women, require in-depth investigation into their underlying mechanisms. While the exact pathophysiology remains unclear, factors such as altered GI motility, visceral hypersensitivity, microbiota imbalance, brain-gut axis dysfunction, digestive tract inflammation, and psychological factors seem to influence the onset and progression of IBS.

So, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aerobic training+ Low fodmap diet

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.

Group Type: EXPERIMENTAL

Aerobic training

Intervention Type: 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.

Low fodmap diet

Intervention Type: 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.

Relaxation techniques + Low fodmap diet

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

Group Type: EXPERIMENTAL

Relaxation techniques

Intervention Type: 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.

Low fodmap diet

Intervention Type: 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.

Low fodmap diet

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

Group Type: ACTIVE_COMPARATOR

Low fodmap diet

Intervention Type: 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.

Interventions

Aerobic training

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.

Intervention Type: OTHER

Relaxation techniques

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.

Intervention Type: OTHER

Low fodmap diet

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alae Ahmed Salem Ismail

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany Ezzat Obaya, PhD

Role: STUDY_CHAIR

Assistant Professor, Cairo university

Locations

Faculty of physical therapy, Cairo University

Giza, , Egypt

Countries

Egypt

Central Contacts

Alae Ahmed Salem Ismail, M.Sc

Role: CONTACT

alaeahmedsalemismail@gmail.com

+20 10 03242511

Rana Hesham Mohamed Elbanna, PhD

Role: CONTACT

Facility Contacts

Alae Ahmed Salem Ismail, M.Sc

Role: primary

alaeahmedsalemismail@gmail.com

+20 10 03242511

Rana Hesham Mohamed Elbanna

Role: backup

Other Identifiers

P.T.REC/012/005264

Identifier Type: -

Identifier Source: org_study_id