Actively Recruiting
Abdominal Rectus Diastasis Microscopy and Rehabilitation
Led by Umeå University · Updated on 2025-01-15
48
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a postoperative rehabilitation program for patients undergoing surgical correction of abdominal rectus diastasis, a condition where the abdominal muscles separate. The study aims to determine if structured abdominal exercises after surgery improve abdominal wall function at three and twelve months and to compare connective tissue components in patients with this condition to healthy individuals. This randomized controlled trial is conducted in Sweden and sponsored by Umeå University. Participants will all undergo surgery to correct the abdominal rectus diastasis by plication of the linea alba. They are randomly assigned to one of two groups: one group follows a postoperative rehabilitation program designed by a physical therapist, while the other group is allowed to exercise freely without a structured program. Blood samples and tissue biopsies from skin, connective tissue, and rectus muscle are collected before and during surgery. Follow-up assessments occur at three and twelve months after surgery. During the study, participants will be evaluated using physical function tests such as the 5 times sit to stand test and repetitions of a 20-kilogram deadlift at three and twelve months post-surgery. They will also complete questionnaires assessing pain, disability, and pelvic floor distress. Safety and progress are monitored through clinical visits and sample collections. The total participation time covers pre-surgery, surgery day procedures, and follow-ups at three and twelve months.
CONDITIONS
Brief Title
Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diastasis wider than 3 cm
- At least 1 year since childbirth
- At least 1 year of stable weight after weight loss
- Body mass index (BMI) less than 30
- Males with diastasis above and below the umbilicus
You will not qualify if you...
- Planned new pregnancy
- Current smoker
- Connective tissue disease
- Receiving immunosuppressive treatment
- Umbilical hernia larger than 2 cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgery by plication of the linea alba. Blood samples are collected before surgery and on the first postoperative day. Biopsies of the skin, connective tissue, and rectus muscle are taken during surgery.
1 surgery visit and 1 postoperative visit (in-person)
Duration - 12 months
Participants are followed up to assess recovery and outcomes after surgery, including physical performance and health questionnaires.
2 visits at 3 and 12 months after surgery (in-person)
Trial Site Locations
Total: 4 locations
1
Surgical clinic at Mora Hospital
Mora, Dalarna County, Sweden, 79251
Actively Recruiting
2
Surgical clinic at Gällivare Hospital
Gällivare, Norrbotten County, Sweden, 98234
Actively Recruiting
3
Surgical clinic at the district hospital of Skellefteå
Skellefteå, Västerbotten County, Sweden, 93141
Actively Recruiting
4
University Hospital of Umeå
Umeå, Västerbotten County, Sweden, 90737
Actively Recruiting
Research Team
A
Annie Silfvenius, Phd-student
K
Karin Strigård, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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