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

NCT05947929 | Completed DMC

• 1 other identifier: IBS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Keywords

Acupuncture; Aerobic exercise; Quality of life

Outcome Measures

Primary Outcomes (3)

• Assessing the change in pain intensity

  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)

  at baseline and after 3 months of intervention

• Assessing the change in level of exertion during physical activity

  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.

  at baseline and after 3 months of intervention

• Assessing the change in Irritable Bowel Syndrome Symptom Severity

  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.

  at baseline and after 3 months of intervention

Study Arms (2)

treadmill exercise Group

EXPERIMENTAL

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

Other: Aerobic excise

acupuncture Group

EXPERIMENTAL

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

Other: acupuncture

Interventions

Aerobic excise 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)\].

treadmill exercise Group

acupuncture 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).

acupuncture Group

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: 30 female patients with IBS
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• NO following any type of diet within 3 months prior to the treatment

You may not qualify if:

• 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 or having a history of joint replacement in any of the joints of the lower limb.
• 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 or balance.
• Using assistive devices for walking (Fani et al., 2019)
• 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,
• Installation of the cardiac pacemaker.
• metal allergy, and fear of the needle.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic faculty of physical therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Manal Nasser Hussein

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: July 17, 2023
• Study Start: May 20, 2021
• Primary Completion: September 15, 2021
• Study Completion: June 25, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

EG (1)