Clinical trial NCT06078085: Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)
Official title: Abdominal Rectus Diastasis Microscopy and Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Rectus Diastasis
Keywords: Randomised controlled trial
Rehabilitation
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One intervention group that receive a postoperative rehabilitation programme. One control group that can train freely.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 5 times sit to stand test time
timeFrame: Three and twelve months after surgery
measure: Number of repetitions of deadlift with 20 kilograms
timeFrame: Three and twelve months after surgery
Secondary outcomes:
measure: VHPQ
timeFrame: Three and twelve months after surgery
measure: PDI-score
timeFrame: Three and twelve months after surgery
measure: PGPQ
timeFrame: Three and twelve months after surgery
measure: PFDI-20 short form
timeFrame: Three and twelve months after surgery
Other outcomes:
Locations:
city: Mora
country: Sweden
facility: Surgical clinic at Mora Hospital
state: Dalarna
city: Gällivare
country: Sweden
facility: Surgical clinic at Gällivare Hospital
state: Norrbotten
city: Skellefteå
country: Sweden
facility: Surgical clinic at the district hospital of Skellefteå
state: Västerbotten
city: Umeå
country: Sweden
facility: University Hospital of Umeå
state: Västerbotten
Study officials:
References: