Randomised Controlled Trial to Assess the Benefit of Naprapathy Training for Preventing Problems from Rectus Abdominis Diastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Abdominal Trunk Function
研究概览
简要总结
A randomised controlled trial with the aim of analysing the effectiveness of a training program intended to prevent symptoms related to DRAM in the postpartum period.
详细描述
Diastasis of the rectus abdominis muscles (DRAM) is a common condition after pregnancy and after great loss of weight. Distension of linea alba is a normal process during pregnancy caused by the growing fetus as well as from hormonal changes.
In the majority of cases, DRAM regresses during the postpartum period and the abdomen resumes its normal function. I some cases, however, the DRAM persists for a long period. This may result in trunk instability, back pain and decreased abdominal muscle strength. Risk factors for persisting DRAM are multiparity, high maternal age and cesarean delivery.
Little is known about how DRAM affects abdominal function. The lack of studies on the impact of DRAM on trunk instability and back pain has made it difficult to evaluate studies aiming at reducing the problems caused by DRAM.
Conservative management, including training aiming at strengthening the abdominal muscles, is usually considered the first hand alternative. There are, however, few studies on the effectiveness of training programs for the purpose of preventing DRAM.
The purpose of the present trial is to evaluate the effectiveness of a specific training program during a limited period of time postpartum in women with DRAM. The investigators also intend to study the changes in anatomy of linea alba during the postpartum period and explore whether the changes are affected by the training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors performing the follow-up ultrasound and clinical examination are blinded to the allocation
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Uni- and multiparous women 3-12 months postpartum
- •Ability to understand Swedish language
- •Ability participate in a three months follow-up program
- •Diastasis of the rectus abdominis muscles > 3 cm
排除标准
- •Ongoing pregnancy
- •Age <18 years or >50 years
- •< 3 months or >12 months post partum
- •History of neurologic, musculoskeletal or psychiatric disorders
- •Interrectal diastasis < 3 cm
结局指标
主要结局
Abdominal Trunk Function
时间窗: One year
Abdominal Trunk Function assessed with the Abdominal Trunk Function Protocol (ATFP). Six separate subscales.
次要结局
- Urinary Incontinence(One year)
- Disability(One year)
- Width of the diastasis(One year)
- Health-related Quality of Life(One year)
- Linea alba distortion index(One year)
- Urinary incontinence(One year)
研究者
Gabriel Sandblom
Research group leader
Karolinska Institutet
