Effect of Whole-body Vibration on Postmenopausal Constipation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient Assessment of Constipation Symptom (PAC - SYM)
研究概览
简要总结
This study will be conducted to investigate the effect of whole-body vibration on postmenopausal constipation
详细描述
Constipation is common in menopause with prevalence ranging from 4% to 29% in various parts of the world. The incidence of constipation among postmenopausal women has been reported to be 37.3%. It can affect the physical, mental and social well-being of women; it reduces individual productivity and creates a significant burden on society and disrupting women's quality of life.
Postmenopausal constipation needs to be treated as it can cause serious problems as hemorrhoids, anal fissures, pelvic organ prolapse and severe pain during defecation.
Laxatives can prevent constipation but its overuse may lead to dependency and decreased bowel function . Also, it may cause some side effects as rectal bleeding, bloody stools, severe cramps or pain, weakness or unusual tiredness, unexplained changes in bowel patterns, severe diarrhea, weakness or unusual tiredness.
Whole body vibration strengthens smooth muscles through oscillation, which causes muscles to rapidly contract and relax. This has been shown to significantly improve the condition of those with chronic functional constipation.
Whole body vibration can aid in minimizing the build up of toxins because it increases blood flow and prevent accumulation of wastes in the colon. Also, it improves gut microbiota that aid in digestion due to increased intestinal permeability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fifty postmenopausal women are clinically diagnosed as having functional constipation after menopause (at least one year after stoppage of last menstrual cycle)
- •Their age will be ranged from 50 to 60 years old.
- •Their body mass index will not exceed 30 kg/m
- •They will not receive any medical treatment.
- •All of them should have at least two criteria of Rome III diagnostic criteria of constipation.
排除标准
- •Irritable bowel syndrome or anal fissures.
- •Genital organ prolapse as rectocele.
- •Any neurological diseases, spinal diseases or spinal deformities.
- •History of bowel surgery.
结局指标
主要结局
Patient Assessment of Constipation Symptom (PAC - SYM)
时间窗: 6 weeks
It is a reliable and valid tool to measure the patient's perspective constipation symptoms in terms of frequency and severity. It is a 12- item that is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Like scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.
次要结局
- Patient Assessment of Constipation quality of life (PAC - QOL)(6 weeks)
研究者
Nouran Mohamed Sabry
Principal investigator
Cairo University