Aerobic Exercise Verus Acupuncture on the Quality of Life in Women Suffering From Irritable Bowel Syndrome [NCT ID Not Yet Assigned]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessing the change in Irritable Bowel Syndrome Symptom Severity
研究概览
简要总结
To compare the effect of aerobic exercise and the acupuncture on the quality of life in women with irritable bowel syndrome
详细描述
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. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Assessing the change in Irritable Bowel Syndrome Symptom Severity
时间窗: 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.
Assessing the change in pain intensity
时间窗: 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)
Assessing the change in level of exertion during physical activity
时间窗: 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.
次要结局
未报告次要终点
研究者
manal nasser husain
Principal Investigator
Cairo University