Back to resultsAerobic Exercise Verus Acupuncture on the Quality of Life in Women Suffering From Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic excise
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Acupuncture, Aerobic exercise, Quality of life
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 - Exclusion Criteria: Patients meeting any of the following criteria will be excluded 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. -
Sites / Locations
- Outpatient clinic faculty of physical therapy cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
treadmill exercise Group
acupuncture Group
Arm Description
30 women will perform treadmill exercise following low food map diet three times \weak for 3 months
30 women will receive acupuncture session following low food map diet three times \ weak for 3 months.
Outcomes
Primary Outcome Measures
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)
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05947929
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
June 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Acupuncture, Aerobic exercise, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treadmill exercise Group
Arm Type
Experimental
Arm Description
30 women will perform treadmill exercise following low food map diet three times \weak for 3 months
Arm Title
acupuncture Group
Arm Type
Experimental
Arm Description
30 women will receive acupuncture session following low food map diet three times \ weak for 3 months.
Intervention Type
Other
Intervention Name(s)
Aerobic excise
Intervention Description
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
Intervention Name(s)
acupuncture
Intervention Description
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).
Primary Outcome Measure Information:
Title
Assessing the change in pain intensity
Description
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)
Time Frame
at baseline and after 3 months of intervention
Title
Assessing the change in level of exertion during physical activity
Description
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.
Time Frame
at baseline and after 3 months of intervention
Title
Assessing the change in Irritable Bowel Syndrome Symptom Severity
Description
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.
Time Frame
at baseline and after 3 months of intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
30 female patients with IBS
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
-
Exclusion Criteria: Patients meeting any of the following criteria will be excluded
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Nasser Hussein
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy cairo university
City
Dokki
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Aerobic Exercise Verus Acupuncture on the Quality of Life in Women Suffering From Irritable Bowel Syndrome
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