Diastasis Recti AbdominisNCT04960800
Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis
A study testing Specific exercises in people with Diastasis Recti Abdominis and Pregnancy Related, run by University of Bergen at 1 site in Norway.
Trial summary
Diastasis Rectus abdominis is a common condition in pregnant and postpartum women, where the connective tissue between the two muscle bellies of the rectus abdominis muscle is stretched and weakened, causing an increased inter-rectus distance. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diastasis Recti Abdominis, Pregnancy Related
- What is being tested?
- Specific exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy pregnant women
- in gestation week 25
- presenting with an inter-rectus distance of 28 mm or more at the level of the umbilicus, and/or 2 cm above and below the umbilicus at rest on initial assessment. Participants presenting with a protrusion along the Linea Alba will also be included, even if they do not meet the inclusion criteria with an inter-rectus distance of 28 mm or more
- Both primi- and multigravida women will be included, and there will be no limitations on number of fetuses
Who cannot join
- pregnancies where exercise is contraindicated
- serious illnesses regarding both mother and fetus
- inability to understand Scandinavian languages
- failure to complete and present an informed consent form
- presence of chronic physical or mental illness incompatible with the intervention
- Exclusion criteria during the study period is stillbirth or premature birth before gestation week 37; onset of serious illnesses regarding both mother and foetus; and pregnancies where exercise is contraindicated
Trial locations and contacts
1 site in 1 country.
Inger Haukenes, PhD contact
About this study
Official title: Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis: Study Protocol for a Randomized Controlled Trial
Diastasis Rectus abdominis is a common condition in pregnant and postpartum women, where the connective tissue between the two muscle bellies of the rectus abdominis muscle is stretched and weakened, causing an increased inter-rectus distance. Treatment of this condition aim to reduce the inter-rectus distance, and conservative treatment including therapeutic exercise is the primary treatment of choice. To date, there is no generally accepted protocol of therapeutic exercises for this condition, and the evidence as to which exercise modality is the most effective and feasible in reducing the inter-rectus distance in women presenting with diastasis rectus abdominis is both sparse and weak. As this condition occur during the last two trimesters of pregnancy and as there is a paucity of high-quality studies on a pregnant population, investigators will conduct a randomized controlled trial on the effect of a specific exercise program during pregnancy on diastasis rectus abdominis.
100 pregnant women in gestation week 25 presenting with diastasis rectus abdominis of ≥ 28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomization. The intervention group will participate in a 12-week specific exercise program, consisting of two group sessions and two self-managed sessions weekly. The control group will not participate in any exercise intervention; however, participants will be recommended to follow national guidelines for general exercise during pregnancy. Participants will be assessed prior to intervention, post intervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-rectus distance in mm, measured by two-dimensional ultrasonography.
- Conditions
- Diastasis Recti Abdominis, Pregnancy Related
- Being tested
- Specific exercises
- Keywords
- pregnancy, ultrasonography, exercise, diastasis recti abdominis, inter-recti distance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific exercisesOther
Specific exercises which aims to contract the recti abdominis combined with functional exercises with the aim to contract all the layers of the anterior abdominal wall. Strengthening dosage will be applied with 3 sets, containing between 8 and 12 repetitions of maximal load.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The participants in the intervention group will participate in a 12- week specific exercise programme led by an experienced women's health physiotherapist. These groups will take place at a private physiotherapy clinic twice a week. In addition, the participants will carry out a self-managed exercise program twice weekly for the same 12-week period. They will be provided with an exercise diary so that adherence to the intervention can be registered and monitored. This exercise diary will be sent to the participants once a week as an electronic questionnaire; this will ensure that the information recorded is standardized and that the research assistant can aid the participants to register their activity and encourage the participants to adhere to the intervention. Receives: Other: Specific exercises |
| Control group | No intervention | The control group will not participate in any exercise intervention. The participants in the control group will be explained the importance of a control group in RCTs and will be recommended to continue with their normal activity levels. They will however, be recommended to follow national guidelines for general exercise during pregnancy and will receive information about these guidelines (15). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be change in inter-rectus distance in mm, measured by two-dimensional ultrasonography.
The inter-rectus distance is the distance between the two muscle bulks of the rectus abdominis muscle. As the two muscle bulks are connected through the connective tissue Linea Alba, the inter-rectus distance is equivalent to the width of the line alba.The inter-rectus distance is measured 2 cm above and 2 cm below the umbilicus. Images of the inter-rectus distance is taken using 2-dimensional ultrasound, and measured using the free Microdicom software. Measurements will be done in mm.
Measured: All participants will be assessed prior to intervention start in gestation week 27. They will then be reassessed at end of the intervention period at gestation week 37. Assessments will also be done 6 weeks, 6 and 12 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study startSep 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diastasis Recti AbdominisStudies of the same condition, open and under way.
- 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
- This will be an exploratory, assessor blinded, randomized, controlled, parallel group trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Inger Haukenes, PhD, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960800
- Sponsor's protocol ID
- 101944102
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Theodorsen NM, Bo K, Fersum KV, Haukenes I, Moe-Nilssen R. Pregnant women may exercise both abdominal and pelvic floor muscles during pregnancy without increasing the diastasis recti abdominis: a randomised trial. J Physiother. 2024 Apr;70(2):142-148. doi: 10.1016/j.jphys.2024.02.002. Epub 2024 Mar 11.
PubMed 38472049Theodorsen NM, Fersum KV, Moe-Nilssen R, Bo K, Haukenes I. Effect of a specific exercise programme during pregnancy on diastasis recti abdominis: study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 4;12(2):e056558. doi: 10.1136/bmjopen-2021-056558.
PubMed 35121606
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04960800
- Acronym / sponsor ID
- 101944102
- Conditions
- Diastasis Recti Abdominis, Pregnancy Related
- Keywords
- pregnancy, ultrasonography, exercise, diastasis recti abdominis, inter-recti distance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Jul 2021 (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.
Diastasis Rectus abdominis is a common condition in pregnant and postpartum women, where the connective tissue between the two muscle bellies of the rectus abdominis muscle is stretched and weakened, causing an increased inter-rectus distance. Treatment of this condition aim to reduce the inter-rectus distance, and conservative treatment including therapeutic exercise is the primary treatment of choice. To date, there is no generally accepted protocol of therapeutic exercises for this condition, and the evidence as to which exercise modality is the most effective and feasible in reducing the inter-rectus distance in women presenting with diastasis rectus abdominis is both sparse and weak. As this condition occur during the last two trimesters of pregnancy and as there is a paucity of high-quality studies on a pregnant population, investigators will conduct a randomized controlled trial on the effect of a specific exercise program during pregnancy on diastasis rectus abdominis.
100 pregnant women in gestation week 25 presenting with diastasis rectus abdominis of ≥ 28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomization. The intervention group will participate in a 12-week specific exercise program, consisting of two group sessions and two self-managed sessions weekly. The control group will not participate in any exercise intervention; however, participants will be recommended to follow national guidelines for general exercise during pregnancy. Participants will be assessed prior to intervention, post intervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-rectus distance in mm, measured by two-dimensional ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be an exploratory, assessor blinded, randomized, controlled, parallel group trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Specific exercisesThe participants in the intervention group will participate in a 12- week specific exercise programme led by an experienced women's health physiotherapist. These groups will take place at a private physiotherapy clinic twice a week. In addition, the participants will carry out a self-managed exercise program twice weekly for the same 12-week period. They will be provided with an exercise diary so that adherence to the intervention can be registered and monitored. This exercise diary will be sent to the participants once a week as an electronic questionnaire; this will ensure that the information recorded is standardized and that the research assistant can aid the participants to register their activity and encourage the participants to adhere to the intervention. |
| Control group | No intervention | –The control group will not participate in any exercise intervention. The participants in the control group will be explained the importance of a control group in RCTs and will be recommended to continue with their normal activity levels. They will however, be recommended to follow national guidelines for general exercise during pregnancy and will receive information about these guidelines (15). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy pregnant women
- in gestation week 25
- presenting with an inter-rectus distance of 28 mm or more at the level of the umbilicus, and/or 2 cm above and below the umbilicus at rest on initial assessment. Participants presenting with a protrusion along the Linea Alba will also be included, even if they do not meet the inclusion criteria with an inter-rectus distance of 28 mm or more
- Both primi- and multigravida women will be included, and there will be no limitations on number of fetuses
Key exclusion criteria (6 listed)
- pregnancies where exercise is contraindicated
- serious illnesses regarding both mother and fetus
- inability to understand Scandinavian languages
- failure to complete and present an informed consent form
- presence of chronic physical or mental illness incompatible with the intervention
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 |
|---|---|---|
| Specific exercisesSpecific exercises which aims to contract the recti abdominis combined with functional exercises with the aim to contract all the layers of the anterior abdominal wall. Strengthening dosage will be applied with 3 sets, containing between 8 and 12 repetitions of maximal load. | Other | Intervention group |
Primary outcome
The primary outcome measure will be change in inter-rectus distance in mm, measured by two-dimensional ultrasonography.
Time frame: All participants will be assessed prior to intervention start in gestation week 27. They will then be reassessed at end of the intervention period at gestation week 37. Assessments will also be done 6 weeks, 6 and 12 months postpartum.
The inter-rectus distance is the distance between the two muscle bulks of the rectus abdominis muscle. As the two muscle bulks are connected through the connective tissue Linea Alba, the inter-rectus distance is equivalent to the width of the line alba.The inter-rectus distance is measured 2 cm above and 2 cm below the umbilicus. Images of the inter-rectus distance is taken using 2-dimensional ultrasound, and measured using the free Microdicom software. Measurements will be done in mm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 38472049Theodorsen NM, Bo K, Fersum KV, Haukenes I, Moe-Nilssen R. Pregnant women may exercise both abdominal and pelvic floor muscles during pregnancy without increasing the diastasis recti abdominis: a randomised trial. J Physiother. 2024 Apr;70(2):142-148. doi: 10.1016/j.jphys.2024.02.002. Epub 2024 Mar 11.
- Derived from this study: PubMed 35121606Theodorsen NM, Fersum KV, Moe-Nilssen R, Bo K, Haukenes I. Effect of a specific exercise programme during pregnancy on diastasis recti abdominis: study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 4;12(2):e056558. doi: 10.1136/bmjopen-2021-056558.
- Individual participant dataSharing planned: No
Related trials for Diastasis Recti Abdominis
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
Risk Factors and Exercise Effects on Abdominal Separation in Seniors
Diastasis Recti Abdominis (DRA), Aging
Recruiting
Effects of Corrective Versus Plank Exercises on Diastasis Recti
Diastasis Recti
Recruiting
Effects of Pilates and Progressive Prone Plank Exercises in Diastasis Recti
Diastasis Recti
Active, not recruiting
Comparative Effects of Telerehabilitation Versus In-Person Core Stability Training in Postpartum Women
Postpartum, Diastasis Recti Abdominis (DRA)
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.
Inger Haukenes, PhD contact
Inger Haukenes, PhD study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific exercises in people with Diastasis Recti Abdominis and Pregnancy Related, run by University of Bergen at 1 site in Norway.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina- Margrethe Theodorsen, MSc (004792483509, nina-margrethe.theodorsen@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure will be change in inter-rectus distance in mm, measured by two-dimensional ultrasonography. (time frame: All participants will be assessed prior to intervention start in gestation week 27. They will then be reassessed at end of the intervention period at gestation week 37. Assessments will also be done 6 weeks, 6 and 12 months postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04960800, which also lists 2 linked publications.
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 22 Jul 2021.