Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

NCT ID: NCT06078085

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2028-12-31

Brief Summary

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The goal of this randomised controlled trial is to evaluate the effect of a postoperative rehabilitation program after surgical correction of abdominal rectus diastasis. The main questions to answer are:

1. Does structured postoperative abdominal exercise improve abdominal wall function in three months and twelve months after surgical correction of abdominal rectus diastasis
2. Does connective tissue components differ in patients with abdominal rectus diastasis when compared to healthy individuals?

Detailed Description

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The investigators want to include patients in Sweden that are eligible for surgical correction of their abdominal rectus diastasis. Patients will be recruited at the surgical clinic at four hospitals in Sweden. After being informed about the study and potential risks, all patient give written informed consent. Randomisation is performed upon inclusion.

All patients undergo surgery by plication of the linea alba. A blood sample is collected prior to the surgery. During the surgery the skin, connective tissue and rectus muscle are biopsied. On the first postoperative day, another blood sample is collected. Follow up is conducted three and twelve months after surgery.

Conditions

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Abdominal Rectus Diastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One intervention group that receive a postoperative rehabilitation programme. One control group that can train freely.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

24 patients that receive a postoperative rehabilitation program to follow after they undergo surgery for abdominal rectus diastasis.

Group Type EXPERIMENTAL

Postoperative rehabilitation program

Intervention Type OTHER

The rehabilitation program is created by a physical therapist

Control

24 patients that undergo surgery for abdominal rectus diastasis and can exercise freely after surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Postoperative rehabilitation program

The rehabilitation program is created by a physical therapist

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diastasis \> 3 cm
* At least 1 year since child birth
* One year of steady weight after weightloss
* BMI \< 30
* Males with diastasis above and below umbilicus

Exclusion Criteria

* New planned pregnancy
* Smoker
* Connective tissue disease
* Immunosuppressive treatment
* Umbilical hernia \> 2 cm
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Karin Strigård

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Surgical clinic at Mora Hospital

Mora, Dalarna County, Sweden

Site Status RECRUITING

Surgical clinic at Gällivare Hospital

Gällivare, Norrbotten County, Sweden

Site Status RECRUITING

Surgical clinic at the district hospital of Skellefteå

Skellefteå, Västerbotten County, Sweden

Site Status RECRUITING

University Hospital of Umeå

Umeå, Västerbotten County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Annie Silfvenius, Phd-student

Role: CONTACT

+46703078690

Karin Strigård, Professor

Role: CONTACT

+46907853583

Facility Contacts

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Anna Nordin, Research assistent

Role: primary

+460250-493313

Gunnar Nordqvist

Role: primary

Annie Silfvenius, Phd-student

Role: primary

+46703078690

Annie Silfvenius, Phd-student

Role: primary

+46703078690

Other Identifiers

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2022-06512-01

Identifier Type: -

Identifier Source: org_study_id

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