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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04501302
Other study ID # TrAEcho01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 25, 2020
Est. completion date May 1, 2021

Study information

Verified date August 2020
Source APOR B de Gasquet
Contact Montserrat Rejano-Campo, MSc
Phone 0033627083914
Email montserejano@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 54
Est. completion date May 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Adults

- Parous

- Women

- Accepting to participe in the research

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
APOR B de Gasquet

Outcome

Type Measure Description Time frame Safety issue
Other Transversus abdominis thickness Transversus abdominis thickness at 1cm lateral from the fascia transversalis measured using ultrasound During the exercise
Other Current lumbopelvic pain intensity Current lumbopelvic pain will be measured using a visual analog scale During the assessement
Other Acute lumbopelvic pain severity The participants will be asked about their lumbopelvic pain mean intensity in the last week using a visual analog scale During the assessement
Other Chronic lumbopelvic pain severity The participants will be asked about their lumbopelvic pain mean intensity in the last 6 months using a visual analog scale During the assessement
Other Urinary symptoms Urinary symptoms will be measured using the Urinary Symptom Profile questionnaires During the assessement
Primary Inter-recti distance The distance between the two medial borders of rectus abdominis muscles is measured using ultrasound During the exercise
Secondary Linea alba thickness Linea alba thickness is measured using ultrasound During the exercise
Secondary Distortion index of the linea alba Average deviation of the linea alba from the shortest path between the recti measured using ultrasound During the exercise
See also
  Status Clinical Trial Phase
Recruiting NCT06286553 - Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training N/A