Irritable Bowel SyndromeNCT06795854
Effect of Aerobic Training Versus Relaxation Techniques on Quality of Life in Patients With Post Covid-19 Irritable Bowel Syndrome
A study testing Aerobic training, Relaxation techniques and Low fodmap diet in people with Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Aerobic training, Relaxation techniques and Low fodmap diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rana Hesham Mohamed Elbanna, PhD contact
Egypt1 site
Faculty of physical therapy, Cairo University
Giza
Alae Ahmed Salem Ismail, M.Sc, +20 10 03242511, alaeahmedsalemismail@gmail.com
Rana Hesham Mohamed Elbanna
About this study
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 .
Read the 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
- Being tested
- Aerobic training, Relaxation techniques, Low fodmap diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
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.
Relaxation techniquesOther
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 dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Other: Low fodmap diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 weeks
Secondary outcomes (2)
The Pittsburgh Sleep Quality Index (PSQI)
It is used to determine self-reported sleep quality and sleep disturbances for the preceding month. It is a 19-item test and consists of seven components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) sleeping medication use and (7) daytime dysfunction. Each component is scored from 0 to 3, and the total score ranges from 0 to 21. The Arabic version of the questionnaire will be used.
Measured: 6 weeks
Perceived Stress Questionnaire (PSQ)
The Perceived Stress Questionnaire (PSQ) assesses an individual's subjective experience of stress, which is crucial for evaluating stress-related symptoms in irritable bowel syndrome (IBS), especially in post-COVID patients. The PSQ includes questions about emotional, time, and social stress, with responses scored on a Likert scale (0-4). Elevated perceived stress is known to exacerbate IBS symptoms, and post-COVID patients often report increased stress due to ongoing health concerns. The PSQ can help identify stress as a key factor in symptom severity, guiding targeted interventions such as stress management techniques (e.g., cognitive behavioral therapy, mindfulness) for better clinical outcomes.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alae Ahmed Salem Ismail, Cairo University
- Investigators
- Hany Ezzat Obaya, PhD, Study chair, Assistant Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795854
- Sponsor's protocol ID
- P.T.REC/012/005264
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Training Versus Relaxation Techniques on Quality of Life in Patients With Post Covid-19 Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06795854
- Acronym / sponsor ID
- P.T.REC/012/005264
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic training+ Low fodmap diet | Experimental | Other: Aerobic training, Other: Low fodmap dietThis 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. |
| Relaxation techniques + Low fodmap diet | Experimental | Other: Relaxation techniques, Other: Low fodmap dietThis 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 |
| Low fodmap diet | Active comparator | Other: Low fodmap dietThis group will include 20 patients. The participants will receive a low fodmap diet only for 6 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingSessions 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. | Other | Aerobic training+ Low fodmap diet |
| Relaxation techniquesRelaxation 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. | Other | Relaxation techniques + Low fodmap diet |
| Low fodmap dietAll 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. | Other | Aerobic training+ Low fodmap diet, Low fodmap diet, Relaxation techniques + Low fodmap diet |
Primary outcome
IBS Severity Scoring System (IBS-SSS)
Time frame: 6 weeks
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.
IBS Quality of Life (IBS-QOL)
Time frame: 6 weeks
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).
2 secondary outcomes
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 weeks
Perceived Stress Questionnaire (PSQ)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rana Hesham Mohamed Elbanna, PhD contact
Hany Ezzat Obaya, PhD study chair
Assistant Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training, Relaxation techniques and Low fodmap diet in people with Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alae Ahmed Salem Ismail, M.Sc (+20 10 03242511, alaeahmedsalemismail@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS Severity Scoring System (IBS-SSS) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.