Impact of Exercise on Diastasis Rectus Abdominus

NCT04049487 | Terminated DMC

• 1 other identifier: 2016673
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastasis Recti and Weakness of the Linea Alba

Keywords

postpartum; diastasis recti; diastasis rectus

Outcome Measures

Primary Outcomes (2)

• Diastasis width comparison

  Measured by the same outcomes assessor, reported in centimeters

  At enrollment (prior to intervention), within 1 week following end of intervention

• Diastasis depth comparison

  Measured by the same outcomes assessor, reported in centimeters

  At enrollment (prior to intervention), within 1 week following end of intervention

Secondary Outcomes (3)

• Back pain comparison

  At enrollment (prior to intervention), within 1 week following end of intervention

• Incontinence comparison

  At enrollment (prior to intervention), within 1 week following end of intervention

• Dyspareunia comparison

  At enrollment (prior to intervention), within 1 week following end of intervention

Study Arms (2)

Generalized Exercise

ACTIVE COMPARATOR

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

Diastasis Specific Exercise

EXPERIMENTAL

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

Interventions

Exercise OTHER

Both groups will participate in group exercise as previously described

Diastasis Specific Exercise; Generalized Exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

MU Healthcare

Columbia, Missouri, 65202, United States

Location

MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer Y Stone, DPT

  University of Missouri Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager, Clinical Rehabilitative Services

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: October 14, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)