Effect of Pelvic Floor Muscle Strengthening and Aerobic Exercises on Uterus Involution
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Existence and Severity of Pain
研究概览
简要总结
The goal of this randomized controlled study was to compare the effect of aerobic exercise and pelvic floor muscle strengthening exercises on uterus involution. In the scope of study following questions will be answered at the end of the study. First which of the exercise type is more effective to enhance uterus involution? Secondly, does exercises induce changes in lactation rate during the study period? Thirdly, does exercises improve the experienced pain? Study will be consisted of three groups as control group, pelvic floor exercise group and aerobic exercise group. Control group will take routine gynaecological treatment. Pelvic floor muscle strengthening exercise group will attend to seven day pelvic floor strengthening exercise programme. Aerobic exercise group will attend to seven day aerobic exercise programme consisting of walking.
详细描述
A total of 45 mothers who satisfies the eligibility criteria of the study will be recruited to the study. Following to the recruitment process mothers will be randomly assigned to the one of the three groups. Mothers in the control group will only take routine gynecologic treatment. Mothers in the aerobic exercise group will attend to aerobic exercises starting from the second day of the hospitalization for one week. Mothers who will be in pelvic floor strengthening exercise group after the randomization will be asked to perform six exercises with moderate difficulty that are recommended by the national association for incontinence.
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)
盲法说明
Interventions and assessment will be performed by separate researchers.
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age of 19 to 35 years
- •New born APGAR score is equal or higher than 8
- •First pregnancy
- •Giving birth in 37th to 40th weeks of the pregnancy
- •Birthweight ranging from 2500 g to 4000 g
排除标准
- •Eclampsia
- •Puerperal psychosis
- •Severe preeclampsia
- •Multiple pregnancy story
- •Uterus abnormality story
- •Uterus surgery story
- •Use of artificial estrogen
- •Existence of systemic, mental or pregnancy related diseases
- •Occurrence of complication during or after the pregnancy
- •Symptoms of uterus subinvolution
结局指标
主要结局
Existence and Severity of Pain
时间窗: Change from baseline pain at one week
Pain will be assessed with visual analog scale (VAS). VAS consists of 10 cm horizontal line. At the one edge of the line 0 point is located meaning no pain, at the other edge 10 point is located meaning worst pain. Mothers will be asked to mark the point matching to their perceived pain. Minimal clinical significance of VAS is reported to be 1.1 or 1.2 cm. VAS and ultrasound imaging will be performed in first, second and eighth days of the study.
Uterus involution
时间窗: Change from baseline uterus involution at one week
To assess the uterus involution uterus volume, uterus diameters and thickness will be measured with ultrasound imaging. Ultrasound imaging will be performed in dorsal lithotomy position, without uterus activation, and with minimal uterus fullness. Uterus volume calculation will be performed with this formula: uterus anteroposterior diameter x uterus transverse diameter x uterus longitudinal diameter x 0.45.
次要结局
- Elapsed time from giving birth to first lactation(First day of the study)
- Daily Lactation Time(Change from baseline daily lactation time at one week)
- Daily Lactation Frequency(Change from baseline daily lactation frequency at one week)
研究者
Omer Dursun
Asst. Prof.
Bitlis Eren University