Effect of Aerobic Training Versus Relaxation Techniques on Quality of Life in Patients With Post Covid-19 Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IBS Severity Scoring System (IBS-SSS)
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index range from 25 to 29.9 kg/m
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Aerobic training (Other)
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.
干预措施: Low fodmap diet (Other)
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
干预措施: Relaxation techniques (Other)
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
干预措施: Low fodmap diet (Other)
Low fodmap diet
This group will include 20 patients. The participants will receive a low fodmap diet only for 6 weeks.
干预措施: Low fodmap diet (Other)
结局指标
主要结局
IBS Severity Scoring System (IBS-SSS)
时间窗: 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)
时间窗: 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).
次要结局
- The Pittsburgh Sleep Quality Index (PSQI)(6 weeks)
- Perceived Stress Questionnaire (PSQ)(6 weeks)
研究者
Alae Ahmed Salem Ismail
Principal Investigator
Cairo University