- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05439668
Comparison of Two Abdominal Exercise Programs on the Interrect Distance
Comparison of Two Abdominal Exercise Programs on the Interrect Distance in Postpartum Woman
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diastasis recti abdominisis the separation of the two rectus abdominis muscles along the linea alba with a consequent separation of fibres and widening of the same. The linea alba has different functions which include supporting the proximal anterior recti, guaranteeing the stability of the vertebral column, pelvis and the pelvic floor, and intervening in the function of the abdominal muscles since it serves as their anterior anchorage.
The crunch abdominal exercise (classic abdominal) is the most studied exercise used to test the behaviour of the linea alba, and in most cases, a decrease in the inter-rectus distance is observed when compared to the resting stage. In the oder hand, Abdominal hypopresives exercises were designed for women in the postpartum period but the effects over the abdominal muscles is unknown and the authors are unaware of any study that evaluates the effect of a hypopressive exercise program on the interrectus distance.
The objective of the research is to compare two programs of exercises in postpartum woman, one based in abdominal strengthening exercises and the other based in abdominal hypopresive exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pontevedra, Spain, 36005
- Iria Da Cuña Carrera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women having given birth 8 weeks before starting the study treatment
- Women agree to participate in the study
- Women with vaginal delivery.
Exclusion Criteria:
- Women with abdominal hernia
- Pregnancy woman
- Previus Abdominal Surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Classic abdominal exercises Group
This group will carry out an abdominal strengthening exercise program based on the classic abdominal exercises.
|
Classic abdominal strengthening exercises (Curl-up, sit-ups and leg-rise), balance exercises, general mobility and upper limb strengthening exercises.
|
|
Experimental: Abdominal hypopresives exercise Group
This group will carry out an abdominal strengthening exercise program based on the abdominal hypopressives exercises.
|
Hypopressive abdominal exercises, balance exercises, general mobility and upper limb strengthening exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interrectus distance measure
Time Frame: Baseline, preintervention
|
he participants will be placed in supine decubitus with the knees flexed to 90º with the feet resting on the stretcher and the arms along the body.
After receiving the instructions to perform an abdominal crunch, subjects are asked to lift their heads and lift shoulders until the scapula lifts off the table.
The ultrasound images will be recorded with an ultrasound scanner (GE Logic and; 4 12MHz, 39mm linear transducer; mode B), in a position of supine rest and a position of muscle activation (isometric contraction), 2 cm and 5 cm above the navel.
Centimeters are the unit of measurement.
|
Baseline, preintervention
|
|
Interrectus distance measure
Time Frame: After the intervention
|
he participants will be placed in supine decubitus with the knees flexed to 90º with the feet resting on the stretcher and the arms along the body.
After receiving the instructions to perform an abdominal crunch, subjects are asked to lift their heads and lift shoulders until the scapula lifts off the table.
The ultrasound images will be recorded with an ultrasound scanner (GE Logic and; 4 12MHz, 39mm linear transducer; mode B), in a position of supine rest and a position of muscle activation (isometric contraction), 2 cm and 5 cm above the navel.
Centimeters are the unit of this measurement.
|
After the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal age
Time Frame: Preintervention
|
Age when the woman gave birth.
This variable will be managed by the midwives through their clinical history.
Years are the unit of this measurement.
|
Preintervention
|
|
Fetal weight
Time Frame: Preintervenrion
|
Weight baby This variable will be managed by the midwives through their clinical history.
Kilogrames are the unit of this measurement.
|
Preintervenrion
|
|
Number of deliveries
Time Frame: Preintervention
|
Total of number of deliveries.
This variable will be managed by the midwives through their clinical history.
Absolut number are the unit of this measurement.
|
Preintervention
|
|
Weight gain during pregnancy
Time Frame: Preintervention
|
Weight gain during pregnancy.
This variable will be managed by the midwives through their clinical history.
Kilogrames are the unit of this measurement.
|
Preintervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iria Da Cuña-carrera, PHD, Universitu of Vigo
Publications and helpful links
General Publications
- Da Cuna-Carrera I, Alonso-Calvete A, Soto-Gonzalez M, Lantaron-Caeiro EM. How Do the Abdominal Muscles Change during Hypopressive Exercise? Medicina (Kaunas). 2021 Jul 9;57(7):702. doi: 10.3390/medicina57070702.
- Lee D, Hodges PW. Behavior of the Linea Alba During a Curl-up Task in Diastasis Rectus Abdominis: An Observational Study. J Orthop Sports Phys Ther. 2016 Jul;46(7):580-9. doi: 10.2519/jospt.2016.6536.
- Carrera Perez C, Da Cuna Carrera I, Gonzalez Gonzalez Y. [What is the best exercise for rehabilitation of abdominal diastasis rehabilitation?]. Rehabilitacion (Madr). 2019 Jul-Sep;53(3):198-210. doi: 10.1016/j.rh.2018.12.004. Epub 2019 Apr 11. Spanish.
- Da Cuna-Carrera I, Alonso-Calvete A, Lantaron-Caeiro EM, Soto-Gonzalez M. Are There Any Differences in Abdominal Activation between Women and Men during Hypopressive Exercises? Int J Environ Res Public Health. 2021 Jun 29;18(13):6984. doi: 10.3390/ijerph18136984.
- Mota P, Pascoal AG, Carita AI, Bo K. The Immediate Effects on Inter-rectus Distance of Abdominal Crunch and Drawing-in Exercises During Pregnancy and the Postpartum Period. J Orthop Sports Phys Ther. 2015 Oct;45(10):781-8. doi: 10.2519/jospt.2015.5459. Epub 2015 Aug 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- 17062022
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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