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Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

Abdominal Rectus Diastasis Microscopy and Rehabilitation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06078085
Acronym
AMIRE
Enrollment
48
Registered
2023-10-11
Start date
2023-03-29
Completion date
2028-12-31
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Rectus Diastasis

Keywords

Randomised controlled trial, Rehabilitation

Brief summary

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

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.

Interventions

OTHERPostoperative rehabilitation program

The rehabilitation program is created by a physical therapist

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
5 times sit to stand test timeThree and twelve months after surgeryAbdominal wall function measured with the 5 times sit to stand test
Number of repetitions of deadlift with 20 kilogramsThree and twelve months after surgeryAbdominal wall function measured

Secondary

MeasureTime frameDescription
VHPQThree and twelve months after surgeryVentral hernia pain questionnaire collect information on the patients experience of pain
PDI-scoreThree and twelve months after surgeryPain disability index collect information on how pain influence daily life attributes. Minimum score 0, maximum score 70. A lower score means less disability.
PGPQThree and twelve months after surgeryPatient goal priority questionnaire collect information on activities the patient wish to improve using the intervention
PFDI-20 short formThree and twelve months after surgeryPelvic floor disability index short form collect information on symptoms from the urogenital organs. Minimum score 0, maximum score 40. Absence of symptoms (score 0), symptoms with mild distress (1-15), symptoms with moderate distress (16-34), symptoms with severe distress (35-40).

Countries

Sweden

Contacts

Primary ContactAnnie Silfvenius, Phd-student
annie.silfvenius@umu.se+46703078690
Backup ContactKarin Strigård, Professor
karin.strigard@umu.se+46907853583

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026