Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

Sponsor

Umeå University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06078085

Collaborator

(none)

Enrollment

Locations

Arms

69.1

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Abdominal Rectus Diastasis	Other: Postoperative rehabilitation program	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Abdominal Rectus Diastasis Microscopy and Rehabilitation

Actual Study Start Date :

Mar 29, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 24 patients that receive a postoperative rehabilitation program to follow after they undergo surgery for abdominal rectus diastasis.	Other: Postoperative rehabilitation program The rehabilitation program is created by a physical therapist
No Intervention: Control 24 patients that undergo surgery for abdominal rectus diastasis and can exercise freely after surgery.

Arm

Intervention/Treatment

Experimental: Intervention

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

Other: Postoperative rehabilitation program

The rehabilitation program is created by a physical therapist

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

5 times sit to stand test time [Three and twelve months after surgery]
Abdominal wall function measured with the 5 times sit to stand test
Number of repetitions of deadlift with 20 kilograms [Three and twelve months after surgery]
Abdominal wall function measured

Secondary Outcome Measures

VHPQ [Three and twelve months after surgery]
Ventral hernia pain questionnaire collect information on the patients experience of pain
PDI-score [Three and twelve months after surgery]
Pain disability index collect information on how pain influence daily life attributes. Minimum score 0, maximum score 70. A lower score means less disability.
PGPQ [Three and twelve months after surgery]
Patient goal priority questionnaire collect information on activities the patient wish to improve using the intervention
PFDI-20 short form [Three and twelve months after surgery]
Pelvic 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surgical clinic at the district hospital of Skellefteå	Skellefteå	Västerbotten	Sweden	93141
2	University Hospital of Umeå	Umeå	Västerbotten	Sweden	90737

Sponsors and Collaborators

Umeå University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karin Strigård, Professor, Umeå University

ClinicalTrials.gov Identifier:

NCT06078085

Other Study ID Numbers:

2022-06512-01

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 11, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karin Strigård, Professor, Umeå University

Randomised controlled trial

Rehabilitation

Additional relevant MeSH terms:

Diastasis, Muscle

Study Results

No Results Posted as of Oct 11, 2023