Diastasis RectiNCT03595696
Core Strengthening for DRA in Postpartum Women
A study testing Core Muscle Strength Training in people with Diastasis Recti and Postpartum, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This study will prospectively measure the effectiveness of a core strengthening program on reducing the inter-rectus distance (IRD) and abdominal wall muscle contraction in postpartum women with diastasis rectus abdominus (DRA). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diastasis Recti, Postpartum, Low Back Pain
- What is being tested?
- Core Muscle Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 16 Jul 2019
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women who have given birth within the last 36 months but are at least 12 weeks postpartum
- Not currently pregnant
- Current DRA diagnosed using ultrasound with an IRD of at least 2.0 cm
Who cannot join
- History of ventral/umbilical hernia prior to pregnancy
- >36 months postpartum
- Currently pregnant
- Beighton's score >5/9
- Unable to participate in a regular core strengthening program
- Unable to attend the three data collection sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 11361
About this study
Official title: Effect of a Core Strengthening Program on Diastasis Rectus Abdominus in Postpartum Women
This study will prospectively measure the effectiveness of a core strengthening program on reducing the inter-rectus distance (IRD) and abdominal wall muscle contraction in postpartum women with diastasis rectus abdominus (DRA). Additionally, this study will aim to investigate and clarify the association between IRD and low back pain.
Read the detailed description
DRA is a separation of the abdominal wall muscles that commonly occurs during pregnancy and is caused by the stretching of the linea alba to accommodate a growing fetus. Separation of core muscles is thought to be factor in postpartum low back pain, stress urinary incontinence, and core strength, as well as being cosmetically undesirable. This study will evaluate the effect of a core strengthening program on shortening the IRD and improving the connectivity and strength of abdominal wall muscles in postpartum women with a DRA. It will also investigate the relationship between IRD and low back pain.
- Conditions
- Diastasis Recti, Postpartum, Low Back Pain
- Being tested
- Core Muscle Strength Training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Muscle Strength TrainingOther
Targeted weekly workouts consisting of low-impact aerobic exercises and resistance exercises designed to address muscle imbalance common in women who exhibit DRA and to prompt automatic core engagement while performing compound, multi-joint movements.
| Study group | Role | What they receive |
|---|---|---|
| Core Strengthening Exercise Intervention | Experimental | All subjects will participate in the study for a total of 24 consecutive weeks. During the first 12 weeks, subjects will participate in weekly online exercise classes for Core Muscle Strength training and will be asked to perform daily homework assignments. Following completion of the 12-week intervention, subjects will be asked to continue the exercises on their own. Receives: Other: Core Muscle Strength Training |
| Control+Core Strengthening Exercise | Active comparator | All subjects will participate in the study for a total of 24 weeks. During the first 12 weeks, subjects will serve as the control group, and they will be advised to continue their baseline level of exercise and lifestyle. During the subsequent 12 weeks, subjects will participate in the exact same program as Group A performed during the first 12 weeks (Core Muscle Strength Training). Receives: Other: Core Muscle Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inter-recti distance (IRD)
Change in IRD will be measured using palpation and musculoskeletal ultrasound.
Measured: Up to 24 weeks
Secondary outcomes (5)
Abdominal wall muscle function
Measured using musculoskeletal ultrasound at rest and during contraction (abdominal draw-in maneuver).
Measured: Up to 24 weeks
Low back pain
Measured using the Quebec Back Pain Disability Scale. Scores range from 0 to 100, with 100 representing higher disability.
Measured: Up to 24 weeks
Pelvic function
Measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function. Scores range from 0 to 48, with a higher score representing greater impairment.
Measured: Up to 24 weeks
Stress urinary incontinence
Measured using the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form. Scores range from 0 to 21, with higher scores indicating increased severity.
Measured: Up to 24 weeks
Body image
Measured using the Body Shape Questionnaire. Scores range from 16 to 96, with a higher score representing impairment.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Oct 2018
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Casey, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595696
- Sponsor's protocol ID
- 2017-1999
- Status last verified
- Nov 2019
- First submitted
- 11 Jul 2018
- Last updated
- 20 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Core Strengthening Program on Diastasis Rectus Abdominus in Postpartum Women
- ClinicalTrials.gov ID
- NCT03595696
- Acronym / sponsor ID
- 2017-1999
- Conditions
- Diastasis Recti, Postpartum, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 23 Jul 2018 (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.
This study will prospectively measure the effectiveness of a core strengthening program on reducing the inter-rectus distance (IRD) and abdominal wall muscle contraction in postpartum women with diastasis rectus abdominus (DRA). Additionally, this study will aim to investigate and clarify the association between IRD and low back pain.
Detailed description
DRA is a separation of the abdominal wall muscles that commonly occurs during pregnancy and is caused by the stretching of the linea alba to accommodate a growing fetus. Separation of core muscles is thought to be factor in postpartum low back pain, stress urinary incontinence, and core strength, as well as being cosmetically undesirable. This study will evaluate the effect of a core strengthening program on shortening the IRD and improving the connectivity and strength of abdominal wall muscles in postpartum women with a DRA. It will also investigate the relationship between IRD and low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Strengthening Exercise Intervention | Experimental | Other: Core Muscle Strength TrainingAll subjects will participate in the study for a total of 24 consecutive weeks. During the first 12 weeks, subjects will participate in weekly online exercise classes for Core Muscle Strength training and will be asked to perform daily homework assignments. Following completion of the 12-week intervention, subjects will be asked to continue the exercises on their own. |
| Control+Core Strengthening Exercise | Active comparator | Other: Core Muscle Strength TrainingAll subjects will participate in the study for a total of 24 weeks. During the first 12 weeks, subjects will serve as the control group, and they will be advised to continue their baseline level of exercise and lifestyle. During the subsequent 12 weeks, subjects will participate in the exact same program as Group A performed during the first 12 weeks (Core Muscle Strength Training). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women who have given birth within the last 36 months but are at least 12 weeks postpartum
- Not currently pregnant
- Current DRA diagnosed using ultrasound with an IRD of at least 2.0 cm
Key exclusion criteria (6 listed)
- History of ventral/umbilical hernia prior to pregnancy
- >36 months postpartum
- Currently pregnant
- Beighton's score >5/9
- Unable to participate in a regular core strengthening program
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 |
|---|---|---|
| Core Muscle Strength TrainingTargeted weekly workouts consisting of low-impact aerobic exercises and resistance exercises designed to address muscle imbalance common in women who exhibit DRA and to prompt automatic core engagement while performing compound, multi-joint movements. | Other | Control+Core Strengthening Exercise, Core Strengthening Exercise Intervention |
Primary outcome
Change in inter-recti distance (IRD)
Time frame: Up to 24 weeks
Change in IRD will be measured using palpation and musculoskeletal ultrasound.
5 secondary outcomes
Abdominal wall muscle function
Time frame: Up to 24 weeks
Low back pain
Time frame: Up to 24 weeks
Pelvic function
Time frame: Up to 24 weeks
Stress urinary incontinence
Time frame: Up to 24 weeks
Body image
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
Related trials for Diastasis Recti
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 Corrective Versus Plank Exercises on Diastasis Recti
Diastasis Recti
Recruiting
Effects of Pilates and Progressive Prone Plank Exercises in Diastasis Recti
Diastasis Recti
Recruiting
Risk Factors and Exercise Effects on Abdominal Separation in Seniors
Diastasis Recti Abdominis (DRA), Aging
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.
Ellen Casey, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Muscle Strength Training in people with Diastasis Recti and Postpartum, run by Hospital for Special Surgery, New York at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 20 Nov 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in inter-recti distance (IRD) (time frame: Up to 24 weeks). 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 20 Nov 2019.