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Diastasis, MuscleTraechoNCT04501302

Effect of Four Exercises on the Inter-recti Distance in Women

An observational study of Diastasis, Muscle, run by APOR B de Gasquet.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Diastasis, Muscle
How many people
54 participants
Where
No sites listed yet
Study dates
25 Sep 2020to 1 May 2021
Phase
Observational
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 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Montserrat Rejano-Campo, MSc contact

0033627083914

montserejano@gmail.com

About this study

Official title: Effect of Four Abdominal and Pelvic Exercises on the Inter-recti Distance in Women: an Observational Study

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.

Read more

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.

Keywords
transversus abdominis, diastasis rectus abdominis, exercise, pelvic floor muscles
Medical subject headings
Diastasis, Muscle, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inter-recti distance

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

    Measured: During the exercise

Secondary outcomes (2)
  1. Linea alba thickness

    Linea alba thickness is measured using ultrasound

    Measured: During the exercise

  2. Distortion index of the linea alba

    Average deviation of the linea alba from the shortest path between the recti measured using ultrasound

    Measured: During the exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start25 Sep 2020 (estimated)
  3. Primary completion1 Feb 2021 (estimated)
  4. Study completion1 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501302
Sponsor's protocol ID
TrAEcho01
Acronym
Traecho
Status last verified
Aug 2020
First submitted
9 Jul 2020
Last updated
6 Aug 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rejano-Campo M, Fuentes-Aparicio L, de Gasquet B. Immediate Effect of Four Exercises on Linea Alba Thickness, Distortion and Inter-Recti Distance in Parous Women. Physiother Res Int. 2026 Apr;31(2):e70185. doi: 10.1002/pri.70185.

    PubMed 41794408

Questions about this trial

What is this clinical trial studying?

An observational study of Diastasis, Muscle, run by APOR B de Gasquet.

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 10 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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Montserrat Rejano-Campo, MSc (0033627083914, montserejano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inter-recti distance (time frame: During the exercise). 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 NCT04501302, which also lists 1 linked publication.

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 6 Aug 2020.

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