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Impact of Exercise on Diastasis Rectus Abdominus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04049487
Recruitment Status : Terminated (Covid)
First Posted : August 8, 2019
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jennifer Y Stone, University of Missouri-Columbia

Brief Summary:
The aim with this research project is to evaluate the success of diastasis recti closure after a 4-week group exercise class that includes: strengthening of each abdominal muscle group, hip strengthening and stabilization, and pelvic floor activation and cueing during exercises. Success will be evaluated by measuring width and depth of linea alba laxity before and after completion of the 4 sessions as well as other outcome measures such as lumbopelvic pain, pain with intercourse, and incontinence. Intervention will be compared to a control group that participates in an exercise program geared toward general health and wellness.

Condition or disease Intervention/treatment Phase
Diastasis Recti and Weakness of the Linea Alba Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be matched and randomly assigned to two groups: a general exercise group and a diastasis specific group. Each group will participate in a 4 week long exercise program.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants will be matched and sorted by a non clinical research staff member. The participant will not know which group they are in, nor will the outcomes assessor. The people who are leading the 2 exercise groups will know which the groups are, but will take care not to mention to participants which group they are in.
Primary Purpose: Treatment
Official Title: Targeted Exercise in a Group Setting Compared to General Group Fitness Class: Impact on Diastasis Recti in Postpartum Women
Actual Study Start Date : October 14, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

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Arm Intervention/treatment
Active Comparator: Generalized Exercise
General wellness/exercise program designed to replicate a generic wellness program that one would find in a gym setting. Will be led by an exercise instructor.
Other: Exercise
Both groups will participate in group exercise as previously described

Experimental: Diastasis Specific Exercise
Diastasis specific exercise program incorporating multiple muscle groups and based on research findings of exercises that are shown to be effective for reducing size and impact of diastasis rectus.
Other: Exercise
Both groups will participate in group exercise as previously described




Primary Outcome Measures :
  1. Diastasis width comparison [ Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention ]
    Measured by the same outcomes assessor, reported in centimeters

  2. Diastasis depth comparison [ Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention ]
    Measured by the same outcomes assessor, reported in centimeters


Secondary Outcome Measures :
  1. Back pain comparison [ Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention ]
    Measured using the Numeric Pain Rating scale. This scale measures pain on a spectrum from 0 (no pain) to 10 (worst pain you can imagine) and is validated for use in comparison within an individual.

  2. Incontinence comparison [ Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention ]
    Measured by presence or absence, frequency of leaking, need for pads

  3. Dyspareunia comparison [ Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention ]
    Using the Marinoff Dyspareunia Scale Score. This scale measures level of dyspareunia (pain with sex) on a spectrum from 0 (no limitations to sex) to 3 (unable to participate in penetrative intercourse due to pain).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 60
  • Has had a vaginal or cesarean delivery between 12 weeks and 2 years ago
  • Has a diastasis measured at least 2 cm wide

Exclusion Criteria:

  • Cardiovascular problems precluding exercise
  • Exercise-induced asthma
  • History of stroke
  • History of abdominal surgery other than a cesarean section
  • Current pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049487


Locations
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United States, Missouri
MU Healthcare
Columbia, Missouri, United States, 65202
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Jennifer Y Stone, DPT University of Missouri Health Care
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Responsible Party: Jennifer Y Stone, Manager, Clinical Rehabilitative Services, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04049487    
Other Study ID Numbers: 2016673
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only the person who is doing data input will have access to IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Y Stone, University of Missouri-Columbia:
postpartum
diastasis recti
diastasis rectus
Additional relevant MeSH terms:
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Diastasis, Muscle
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries