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临床试验/NCT04652830
NCT04652830招募中不适用

Randomised Controlled Trial to Assess the Benefit of Naprapathy Training for Preventing Problems from Rectus Abdominis Diastasis

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年3月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Sandblom

Research group leader

Karolinska Institutet

研究点 (2)

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