The AfterBabyBodyStudy- Testing Manual Examination Methods and Exercise Effects on Muscular Recovery After Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Urinary incontinence
研究概览
简要总结
Exercising postpartum is important for the health of mother and child. However, there are physical changes postpartum which can prevent women from exercising postpartum. About 30% of women postpartum have problems with stress urinary incontinence. Almost as many have a remaining separation of the two parts of the muscle rectus abdominis. Over the last decenium there has been an increased interest but also disparate information about these conditions. This has led to an increased uncertainty among women who wants to resume exercising postpartum. More and more women seek help of physiotherapists to verify an appropriate function in their muscles after pregnancy. However, reliable and valid examination methods are scarce and it is unclear how to interpret the examination results to give individualized exercise advice.
The aim of this study is to test the reliability of examination methods for the pelvic floor function and separation of the rectus abdominis and the criterion validity of these examination methods regarding exercising without leaking urine and lumbopelvic pain. Another aim is to identify if exercising postpartum has effects on the function of the muscles and (less) leaking of urine and lumbopelvic pain/disability.
Recruitment of 300 women approximately 8 weeks postpartum in the Region Västra Götaland. For testing interrater reliability on manual examination of the pelvic floor and the separation of the rectus abdominis by caliper two physiotherapists will examine the participants´ pelvic floor and abdominal muscles. The examinations will be tested for criterion validity using a questionnaire for pelvic floor function, lumbopelvic pain/disability and physical activity level. In an observational component of this study the questionnaire will also be used to evaluate the effects of exercising postpartum on the recovery of pelvic floor and abdominal muscles at 6, 9 and 12 months postpartum.
This study will provide knowledge about the reliability of examination methods for pelvic floor function and separation of the rectus abdominis, their correlation to urinary leakage and pain/disability (criterion validity) and the effects of exercising on muscle function postpartum.
详细描述
Introduction Exercising postpartum is important for the health of mother [1-3] and child [4]. However, there are physical changes postpartum which can prevent women from exercising postpartum. About 30% of women postpartum have problems with stress urinary incontinence [5]. Between 20-50% of women describe that urine leakage impact their physical activity level [6-8]. Another concern is a remaining separation of the two parts of the rectus abdominis (diastasis rectus abdominis-DRA) which is present in about 30% of women one year postpartum [9]. There is an ongoing discussion about if the DRA is a cause for instability and it is controversial if a DRA is a source for low back and pelvic pain and pelvic floor dysfunction [9-12]. Discussions about how heavy lifting of the growing child and different exercises can harm or benefit the DRA [13] cause an uncertainty among women who want to exercise postpartum. In recent years an increasing number of women are seeking help from physiotherapists in primary care to get physiotherapeutic examination and advice before resuming exercising.
Physiotherapists assess the pelvic floor and abdominal muscles postpartum. Their standard method for pelvic floor muscles evaluation is vaginal palpation using the modified oxford scale [14, 15]. Vaginal palpation is the only method evaluating the ability to perform a correct contraction described as a squeeze with lift- the pelvic floor function [15]. However, researchers are still struggling to rate this function on a scale. The challenge is to rate two movements in one scale [14, 16]. Current studies often just assess the strength component of the contraction [14, 16] with just fair interrater reliability. Other researchers developed scales assessing different qualities of function [17-19] which makes them difficult to apply clinically while palpating at the same time. In the physiotherapeutic assessment the function of a muscle is important. In this study functional components like in the Devreese [17] or Brink scale [20] will be added to the modified oxford scale. Defining the values of the oxford scale more functionally creates the hypothesis that physiotherapists will have easier to agree in their assessments. Another question is which function in the pelvic floor is requested to resume exercising postpartum without leaking urine. The assumption that a strong pelvic floor leads to less stress urinary incontinence is discussed [21, 22]. However, pelvic floor training shows good effect against urinary incontinence [23], According to our knowledge is the correlation between function and exercising postpartum without leaking urine not investigated yet.
For examination of the DRA 96 % of physiotherapists specialized in women´s health use the finger-width method [9, 13]. This method has weaker interrater reliability than instrumental measurement methods [24] and is inaccurate due to variations of finger-width [25]. Assessment of the DRA with a caliber shows almost equally good accuracy like ultrasound assessment [24, 26], it allows the documentation of changes eg the recovery postpartum. However, below 2 % of physiotherapists are using caliper for assessment of postpartum women [13], the interrater reliability is not tested yet. Furthermore there is no international consensus about how to classify the DRA [24], and it is still discussed which width of the DRA can be associated with a dysfunction such as lumbopelvic pain or stress urinary incontinence [9, 10].
The recovery of the pelvic floor and the abdominal muscles occur under the first year after giving birth [9, 27]. International guidelines for exercise postpartum are still scarce and not based on results of RCT´s; especially when it comes to exercises which put high strain on the pelvic floor [28-30]. If and when exercising affects the recovery of pelvic floor function and DRA postpartum is not yet known [6, 22, 31-35]. There are two different hypothesis regarding effects of physical training on the pelvic floor a) physical training is strengthening or b) physical training is weakening the pelvic floor [22, 36]. If physical training in the early postpartum period leads to a better pelvic floor function and less urinary incontinence needs to be investigated.
The effects of different abdominal exercises on the recovery of the DRA is controversy discussed [34, 37, 38]. A review based on low quality studies suggest that all physical activity improves the DRA postpartum [34]. Little is known about the effects of different types of exercising on the recovery of the DRA and further research is needed [39, 40].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women -over 18 years, ability to understand Swedish in spoken and written terms, gave birth to a child approximately 3 months ago via vaginal delivery or cesarean section will be included.
排除标准
- •chronic pain in the pelvis or back (defined as pain in pelvic or back in more than 3 months before pregnancy),
- •major rupture of the pelvic floor at delivery e.g. sphincter rupture grade III/IV
- •other diseases or surgery that prevents examination of the pelvic floor or abdominal muscles.
结局指标
主要结局
Urinary incontinence
时间窗: From baseline to 12 month follow upp
Urinary incontinence assessed by ICIQ-UI short form (rated from 0-21, + questions about functional leakage)
Lumbopelvic pain/disability
时间窗: From baseline to 12 month follow upp
assessed by oswestry disability index/Roland morris disability index (0-100% function)/pelvic girdle pain questionnaire (0-100% function)
Pelvic floor function
时间窗: From baseline to 12 month follow upp
Pelvic floor function will be rated on a modified oxford scale (0 = no contraction, 1 = flicker, 2 = weak, no lift, 3 = good contraction with lift, 4 = maximal contraction (with lift) and 5 = maximal contraction with lift over 5 seconds.
Diastasis recti abdominis
时间窗: From baseline to 12 month follow upp
measured in mm by a caliper
次要结局
未报告次要终点
研究者
Maria Larsson
Associate Professor
Vastra Gotaland Region
