Functional Dyspepsia Response to Relaxation Therapy Alone or Combined With Physical Activity
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- cortisol
研究概览
简要总结
Functional dyspepsia (FD) is a common gastrointestinal disease with high morbidity. Due to the drop in estrogen level, perimenopausal women with FD (PMFD) have an increase in emotional disorders such as depression, anxiety and sleep disorder.
详细描述
the research will include 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation), physical exercise (on treadmill), and proton pump inhibitors. Also, the research will include another 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation) and proton pump inhibitors
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
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •perimenopausal women With FD symptoms
排除标准
- •other gastrointestinal disease
- •Cardiovascular, metabolic, respiratory, renal complaints
- •Pregnancy
- •Women in Lactation
- •neurological / Psychic Women
研究组 & 干预措施
group A
This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose), Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time), physical activity ( five session per the week conducted on treadmill, 30 minutes in the first treatment month and 40 minutes in the second treatment month)
干预措施: relaxation and physical activity (Behavioral)
Group B
This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose) and Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time)
干预措施: relaxation (Behavioral)
结局指标
主要结局
cortisol
时间窗: It will be measured after 8 weeks
stress hormone will be measured in serum
次要结局
- depression anxiety stress scales-42(It will be measured after 8 weeks)
- Pittsburgh sleep quality index(It will be measured after 8 weeks)
- Glasgow dyspepsia severity score(It will be measured after 8 weeks)
- Visual analogue scale(It will be measured after 8 weeks)
- Estradiol(It will be measured after 8 weeks)
研究者
Ali Mohamed Ali ismail
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Cairo University