Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID04652830

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

Led by Karolinska Institutet · Updated on 2025-01-03

70

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

H

Hela Kvinnans Klinik

Collaborating Sponsor

AI-Summary

What this Trial Is About

Diastasis of the rectus abdominis muscles (DRAM) is a common condition after pregnancy and significant weight loss, involving the stretching of the linea alba. Although DRAM often improves postpartum, some women experience persistent muscle separation, leading to trunk instability, back pain, and reduced abdominal strength. This trial examines the effectiveness of a specific naprapathy training program to prevent symptoms related to DRAM in postpartum women. The study is a randomized single-blind controlled trial including women with more than 3 cm diastasis. Participants are divided into two groups: one performs a naprapathy training program for three months with exercises lasting ten minutes six days a week plus short exercises three times a day, while the control group maintains their usual routines. Ultrasound and physical measurements of the abdominal wall, along with questionnaires on physical activity, pain, function, back pain, urinary incontinence, and quality of life, are collected at the start, six months, and twelve months. Participants will undergo ultrasound assessments of the linea alba width and laxity, abdominal circumference measurements, and complete several questionnaires at three time points. The primary outcome is abdominal trunk function after one year, with secondary outcomes including disability, urinary incontinence, quality of life, and anatomical changes of the diastasis. The study monitors changes over time and evaluates the impact of the training program on symptoms and anatomy, with a total follow-up of one year.

CONDITIONS

Brief Title

Naprapathy Training for Postpartum DRAM Prevention

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Age between 18 and 50 years
Not Eligible

You will not qualify if you...

  • Ongoing pregnancy
  • Age <18 years or >50 years
  • Less than 3 months or more than 12 months postpartum
  • History of neurologic, musculoskeletal or psychiatric disorders
  • Interrectal diastasis less than 3 cm

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 3 months

Participants randomized to the training program perform abdominal muscle exercises for three months, while control participants continue their usual routines without added training.

Daily exercise sessions with a few brief exercises throughout each day

Follow-up

Duration - Up to 12 months after enrollment

All participants attend follow-up visits at 6 and 12 months after starting the study to assess abdominal wall condition and complete questionnaires on physical function and quality of life.

2 visits (in-person) at 6 and 12 months

Trial Site Locations

Total: 1 location

1

Hela Kvinnans Klinik

Stockholm, Sweden, 116 37

Actively Recruiting

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Research Team

K

Katarina Woxnerud, Naprapath

G

Gabriel Sandblom, Ass Prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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