Clinical trial NCT05947929: Aerobic Exercise Verus Acupuncture on the Quality of Life in Women Suffering From Irritable Bowel Syndrome
Official title: Aerobic Exercise Verus Acupuncture on the Quality of Life in Women Suffering From Irritable Bowel Syndrome [NCT ID Not Yet Assigned]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Acupuncture
Aerobic exercise
Quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To compare the effect of aerobic exercise and the acupuncture on the quality of life in women with irritable bowel syndrome

Detailed description: Patients with IBS have a higher prevalence of migraine, fibromyalgia and depression.

Donald et al. have shown that physically active elderly participants were less likely to be constipated than their less active counterparts.

On the quality of life Physical activity has also been shown to reduce mouth-to-anus transit time and among individuals with constipation, higher levels of physical activity were found to be associated with improved physical functioning and health perceptions. Similarly, other finding studies are not consistent with some small observational studies which have failed to report positive associations between exercise and constipation, reported that orocecal transit time was accelerated during mild exercise. Of some relevance to the findings reported here is a recent randomized controlled trials (RCT) that found walking to be an effective intervention for improving the degree of bowel cleansing in preparation for a colonoscopy. There is a contradiction between studies.

However, study results on acupuncture in IBS are mixed, and more larger trials are needed to fully support the claims of acupuncture in helping with IBS there's a contradiction between the studies so, the present study will be conducted to compare the effect of aerobic exercise and acupuncture on women with irritable bowel syndrome and to solve the contradiction. .

Eligibility criteria: Inclusion Criteria:1- Sixcity Females with mild and moderate IBS from Owsim General Hospital. Being able to increase the level of physical activity.

2- Their age will be 35 to45 years old 3- Stable vital signs ( blood pressure , respiratory rate and temperature) 4- BMI \<30 (Fani et al., 2019) 5- Patients meeting the Rome III diagnostic criteria for IBS. 6- Baseline IBS-SSS score from 75to 299(mild and moderate) 7- No medication for IBS (except for emergency) within at least 2 weeks ago. 8- No acupuncture therapy within 3 months prior to study recruitment (Lixia et al., 2018).

9- NO following any type of diet within 3 months prior to the treatment

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Exclusion Criteria: Patients meeting any of the following criteria will be excluded

1. The patient has a history of rheumatic diseases in the lower limb.
2. Having a history of metabolic, neurologic, cardiovascular, respiratory, renal, and lung problems which would prevent them from participating in aerobic exercises.
3. Having a history of knee injury or knee surgery during the past year or having a history of joint replacement in any of the joints of the lower limb.
4. Having a history of fracture in the lower limb during the past six months
5. Major vision disorders.
6. Hereditary or acquired musculoskeletal disorders in the lower limb.
7. Organic gastrointestinal disorders.
8. Using drugs that would affect metabolism or balance.
9. Using assistive devices for walking (Fani et al., 2019)
10. Intestinal organic diseases or systemic diseases affecting gastrointestinal motility (such as gallbladder pancreatitis, hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases).
11. History of abdominal or rectal anus surgery.
12. pregnancy or breastfeeding, and post-partum 12 months,
13. Installation of the cardiac pacemaker.
14. metal allergy, and fear of the needle.

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Primary outcomes:
measure: Assessing the change in pain intensity
timeFrame: at baseline and after 3 months of intervention
measure: Assessing the change in level of exertion during physical activity
timeFrame: at baseline and after 3 months of intervention
measure: Assessing the change in Irritable Bowel Syndrome Symptom Severity
timeFrame: at baseline and after 3 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physical therapy cairo university
Study officials:
affiliation: Cairo University
name: Manal Nasser Hussein
role: PRINCIPAL_INVESTIGATOR
References: