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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Irritable Bowel Syndrome

Treatments

Other: Relaxation techniques
Other: Aerobic training
Other: Low fodmap diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06795854
P.T.REC/012/005264

Details and patient eligibility

About

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 .

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 30 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Aerobic training+ Low fodmap diet
Experimental group
Description:
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.
Treatment:
Other: Low fodmap diet
Other: Aerobic training
Relaxation techniques + Low fodmap diet
Experimental group
Description:
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
Treatment:
Other: Low fodmap diet
Other: Relaxation techniques
Low fodmap diet
Active Comparator group
Description:
This group will include 20 patients. The participants will receive a low fodmap diet only for 6 weeks.
Treatment:
Other: Low fodmap diet

Trial contacts and locations

1

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Central trial contact

Alae Ahmed Salem Ismail, M.Sc; Rana Hesham Mohamed Elbanna, PhD

Data sourced from clinicaltrials.gov

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