Aerobic Exercise Verus Acupuncture on the Quality of Life in Women Suffering From Irritable Bowel Syndrome

• ClinicalTrials.gov Identifier: NCT05947929
• Recruitment Status: Completed
• First Posted: July 17, 2023
• Last Update Posted: July 18, 2023
• Sponsor: Cairo University
• Information provided by (Responsible Party): manal nasser husain, Cairo University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Other: Aerobic excise; Other: acupuncture	Not Applicable

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. .

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Aerobic Exercise Verus Acupuncture on the Quality of Life in Women Suffering From Irritable Bowel Syndrome [NCT ID Not Yet Assigned]
• Actual Study Start Date: May 20, 2021
• Actual Primary Completion Date: September 15, 2021
• Actual Study Completion Date: June 25, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: treadmill exercise Group; 30 women will perform treadmill exercise following low food map diet three times \weak for 3 months	Other: Aerobic excise; the treadmill exercises three times a week for 12 weeks) based on the Following protocol: Intensity exercise: determined by karvonen formula: Exercise heart rate = [(A-B) × desired intensity] + B [A represents maximum heart rate (220-age) and B for resting heart rate (average of three measurements)]. The desired intensity will be at 50- 70%. Heart rate was measured by pulse-meter to detect pulse rate before exercise (Resting HR)].
Experimental: acupuncture Group; 30 women will receive acupuncture session following low food map diet three times \ weak for 3 months.	Other: acupuncture; the acupuncture needles will be inserted through the adhesive pads. The acupuncture needles used in the study are 40 mm in length and 0.30 mm in diameter and manufactured by Suzhou Hwato Medical Instruments Co. Ltd (Suzhou, China). The following acupoints will be used: DU20 (Baihui), ST36 (Zusanli), ST37 (Shangjuxu), SP6 (Sanyinjiao), ST25 (Tianshu), and LR3 (Taichong).

Outcome Measures

Primary Outcome Measures :

1. Assessing the change in pain intensity [ Time Frame: at baseline and after 3 months of intervention ]
   By using visual anaglouge scale. The visual analog scale (VAS) is the VAS, which consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) , to the worst pain that could possibly feel (10)
2. Assessing the change in level of exertion during physical activity [ Time Frame: at baseline and after 3 months of intervention ]
   The Borg scale is a numerical scale that ranges from 6 to 20 where 6 means "no exertion at all" and 20 means "maximal exertion." When a measurement is taken, a number is chosen from the following scale by an individual that best describes their level of exertion during physical activity.
3. Assessing the change in Irritable Bowel Syndrome Symptom Severity [ Time Frame: at baseline and after 3 months of intervention ]
   by Irritable Bowel Syndrome Symptom Severity Score (IBS- SSS). Patients completed IBS-SSS questionnaire for assessing their eligibility for the study. IBS-SSS questionnaire contains five questions which would measure pain severity, pain frequency, abdominal bloating, bowel habit dissatisfaction, and life interference using Visual Analogue Scale (VAS). The mean score of each item ranges from 0 to 100 and the total mean score of the questionnaire ranges from 0 to 500; higher scores indicates more severe symptoms.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: 30 female patients with IBS
• Accepts Healthy Volunteers: No

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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Contacts and Locations

Locations

Egypt

Outpatient clinic faculty of physical therapy cairo university

Dokki, Egypt

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Manal Nasser Hussein; Cairo University

More Information

• Responsible Party: manal nasser husain, Principal Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT05947929
• Other Study ID Numbers: IBS
• First Posted: July 17, 2023
• Last Update Posted: July 18, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by manal nasser husain, Cairo University:

Acupuncture; Aerobic exercise; Quality of life

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases