Abdominal Rectus DiastasisAMIRENCT06078085
Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)
A study testing Postoperative rehabilitation program in people with Abdominal Rectus Diastasis, run by Umeå University at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Rectus Diastasis
- What is being tested?
- Postoperative rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesSweden
- Study dates
- 29 Mar 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- New planned pregnancy
- Smoker
- Connective tissue disease
- Immunosuppressive treatment
- Umbilical hernia > 2 cm
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Surgical clinic at Gällivare Hospital
Gällivare, Norrbotten County, 98234
Surgical clinic at Mora Hospital
Mora, Dalarna County, 79251
Surgical clinic at the district hospital of Skellefteå
Skellefteå, Västerbotten County, 93141
University Hospital of Umeå
Umeå, Västerbotten County, 90737
About this study
Official title: Abdominal Rectus Diastasis Microscopy and Rehabilitation
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?
Read the 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.
- Conditions
- Abdominal Rectus Diastasis
- Being tested
- Postoperative rehabilitation program
- Keywords
- Randomised controlled trial, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative rehabilitation programOther
The rehabilitation program is created by a physical therapist
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 24 patients that receive a postoperative rehabilitation program to follow after they undergo surgery for abdominal rectus diastasis. Receives: Other: Postoperative rehabilitation program |
| Control | No intervention | 24 patients that undergo surgery for abdominal rectus diastasis and can exercise freely after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 times sit to stand test time
Abdominal wall function measured with the 5 times sit to stand test
Measured: Three and twelve months after surgery
Number of repetitions of deadlift with 20 kilograms
Abdominal wall function measured
Measured: Three and twelve months after surgery
Secondary outcomes (4)
VHPQ
Ventral hernia pain questionnaire collect information on the patients experience of pain
Measured: Three and twelve months after surgery
PDI-score
Pain disability index collect information on how pain influence daily life attributes. Minimum score 0, maximum score 70. A lower score means less disability.
Measured: Three and twelve months after surgery
PGPQ
Patient goal priority questionnaire collect information on activities the patient wish to improve using the intervention
Measured: Three and twelve months after surgery
PFDI-20 short form
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).
Measured: Three and twelve months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start29 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Rectus DiastasisStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One intervention group that receive a postoperative rehabilitation programme. One control group that can train freely.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Strigård, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078085
- Sponsor's protocol ID
- 2022-06512-01
- Acronym
- AMIRE
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Rectus Diastasis Microscopy and Rehabilitation
- ClinicalTrials.gov ID
- NCT06078085
- Acronym / sponsor ID
- AMIRE / 2022-06512-01
- Conditions
- Abdominal Rectus Diastasis
- Keywords
- Randomised controlled trial, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One intervention group that receive a postoperative rehabilitation programme. One control group that can train freely.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Postoperative rehabilitation program24 patients that receive a postoperative rehabilitation program to follow after they undergo surgery for abdominal rectus diastasis. |
| Control | No intervention | –24 patients that undergo surgery for abdominal rectus diastasis and can exercise freely after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- New planned pregnancy
- Smoker
- Connective tissue disease
- Immunosuppressive treatment
- Umbilical hernia > 2 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative rehabilitation programThe rehabilitation program is created by a physical therapist | Other | Intervention |
Primary outcome
5 times sit to stand test time
Time frame: 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
Time frame: Three and twelve months after surgery
Abdominal wall function measured
4 secondary outcomes
VHPQ
Time frame: Three and twelve months after surgery
PDI-score
Time frame: Three and twelve months after surgery
PGPQ
Time frame: Three and twelve months after surgery
PFDI-20 short form
Time frame: Three and twelve months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Abdominal Rectus Diastasis
Active, not recruiting
Abdominal Rectus Diastasis (ARD) Reconstruction
Rectus Diastasis
Recruiting
Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
Diastasis Recti Abdominis, Abdominal Wall Laxity
Recruiting
Effects of Pilates and Progressive Prone Plank Exercises in Diastasis Recti
Diastasis Recti
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative rehabilitation program in people with Abdominal Rectus Diastasis, run by Umeå University at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 times sit to stand test time (time frame: Three and twelve months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.