NCT04501302

Brief Summary

Diastasis rectus abdominis (DRA) is defined as an excessive separation between the two abdominal rectus muscles. It is generally quantified by the inter-recti distance. In postpartum women, the prevalence of diastasis is 60% six weeks after delivery. The increase in the inter-recti distance has been associated with a decrease in strength and endurance of the trunk flexors and rotators (p \< 0.05). Exercise during pregnancy has been shown to be helpful in the treatment of DRA. Nevertheless, there is still not strong evidence to establish what kind of exercise should be recommended during pregnancy and in postpartum. The aim of this study is to compare the morphological and functional changes of the linea alba during four exercises. Inter-recti distance, linea alba thickness and distortion index will be measured at rest, as well as during 4 exercises (draw in maneuver, crunch, pelvic floor muscle contraction and a "de Gasquet" exercise). Subgroup analysis will be performed to determine if the presence or absence of an abdominal diastasis has an influence on these outcomes. A cross-sectional pilot study will be carried out. The main outcome measure will the inter-recti distance. Secondary outcomes will be the thickness of linea alba and distortion index.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

July 9, 2020

Last Update Submit

August 2, 2020

Conditions

Keywords

transversus abdominis, diastasis rectus abdominis, exercise, pelvic floor muscles

Outcome Measures

Primary Outcomes (1)

  • Inter-recti distance

    The distance between the two medial borders of rectus abdominis muscles is measured using ultrasound

    During the exercise

Secondary Outcomes (2)

  • Linea alba thickness

    During the exercise

  • Distortion index of the linea alba

    During the exercise

Other Outcomes (5)

  • Transversus abdominis thickness

    During the exercise

  • Current lumbopelvic pain intensity

    During the assessement

  • Acute lumbopelvic pain severity

    During the assessement

  • +2 more other outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult parous women attending to several physiotherapy centers in Paris will be recruited

You may qualify if:

  • Adults
  • Parous
  • Women
  • Accepting to participe in the research

You may not qualify if:

  • Under curatorship
  • Persons deprived of their liberty by judicial or administrative decision
  • Having intellectual limitations that may limit the understanding of questionnaires or exercises
  • With limitations in understanding the French language
  • Pregnant women
  • History of pelvic / spine fractures
  • History of pelvic surgery
  • History of spinal surgery
  • History of abdominal surgery
  • History of lower limbs weakness, changes in osteotendinous reflexes or loss of sensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diastasis, MuscleMotor Activity

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesBehavior

Central Study Contacts

Montserrat Rejano-Campo, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

August 6, 2020

Study Start

September 25, 2020

Primary Completion

February 1, 2021

Study Completion

May 1, 2021

Last Updated

August 6, 2020

Record last verified: 2020-08