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

NCT ID: NCT05947929

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2022-06-25

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. .

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

treadmill exercise Group

30 women will perform treadmill exercise following low food map diet three times \\weak for 3 months

Group Type: EXPERIMENTAL

Aerobic excise

Intervention Type: OTHER

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)\].

acupuncture Group

30 women will receive acupuncture session following low food map diet three times \\ weak for 3 months.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

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).

Interventions

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)\].

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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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• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

manal nasser husain

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manal Nasser Hussein

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Outpatient clinic faculty of physical therapy cairo university

Dokki, , Egypt

Countries

Egypt

Other Identifiers

IBS

Identifier Type: -

Identifier Source: org_study_id