- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501302
Effect of Four Exercises on the Inter-recti Distance in Women (Traecho)
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.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Montserrat Rejano-Campo, MSc
- Phone Number: 0033627083914
- Email: montserejano@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inter-recti distance
Time Frame: During the exercise
|
The distance between the two medial borders of rectus abdominis muscles is measured using ultrasound
|
During the exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Linea alba thickness
Time Frame: During the exercise
|
Linea alba thickness is measured using ultrasound
|
During the exercise
|
Distortion index of the linea alba
Time Frame: During the exercise
|
Average deviation of the linea alba from the shortest path between the recti measured using ultrasound
|
During the exercise
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transversus abdominis thickness
Time Frame: During the exercise
|
Transversus abdominis thickness at 1cm lateral from the fascia transversalis measured using ultrasound
|
During the exercise
|
Current lumbopelvic pain intensity
Time Frame: During the assessement
|
Current lumbopelvic pain will be measured using a visual analog scale
|
During the assessement
|
Acute lumbopelvic pain severity
Time Frame: During the assessement
|
The participants will be asked about their lumbopelvic pain mean intensity in the last week using a visual analog scale
|
During the assessement
|
Chronic lumbopelvic pain severity
Time Frame: During the assessement
|
The participants will be asked about their lumbopelvic pain mean intensity in the last 6 months using a visual analog scale
|
During the assessement
|
Urinary symptoms
Time Frame: During the assessement
|
Urinary symptoms will be measured using the Urinary Symptom Profile questionnaires
|
During the assessement
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TrAEcho01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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