Postpartum PeriodNCT05439668
Comparison of Two Abdominal Exercise Programs on the Interrect Distance
A study testing Classic abdominal strengthening exercises and Hypopressive abdominal exercises program in people with Postpartum Period, run by University of Vigo at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period
- What is being tested?
- Classic abdominal strengthening exercises and Hypopressive abdominal exercises program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 3 Dec 2022
- Phase
- Interventional
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women having given birth 8 weeks before starting the study treatment
- Women agree to participate in the study
- Women with vaginal delivery.
Who cannot join
- Women with abdominal hernia
- Pregnancy woman
- Previus Abdominal Surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Abdominal Exercise Programs on the Interrect Distance in Postpartum Woman
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.
Read the 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.
- Conditions
- Postpartum Period
- Being tested
- Classic abdominal strengthening exercises, Hypopressive abdominal exercises program
- Keywords
- Abdominal muscle, Interrectus distance, Abdominal hypopressive exercise, Abdominal crunch exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic abdominal strengthening exercisesOther
Classic abdominal strengthening exercises (Curl-up, sit-ups and leg-rise), balance exercises, general mobility and upper limb strengthening exercises.
Hypopressive abdominal exercises programOther
Hypopressive abdominal exercises, balance exercises, general mobility and upper limb strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Classic abdominal exercises Group | Experimental | This group will carry out an abdominal strengthening exercise program based on the classic abdominal exercises. Receives: Other: Classic abdominal strengthening exercises |
| Abdominal hypopresives exercise Group | Experimental | This group will carry out an abdominal strengthening exercise program based on the abdominal hypopressives exercises. Receives: Other: Hypopressive abdominal exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interrectus distance measure
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.
Measured: Baseline, preintervention
Interrectus distance measure
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.
Measured: After the intervention
Secondary outcomes (4)
Maternal age
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.
Measured: Preintervention
Fetal weight
Weight baby This variable will be managed by the midwives through their clinical history. Kilogrames are the unit of this measurement.
Measured: Preintervenrion
Number of deliveries
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.
Measured: Preintervention
Weight gain during pregnancy
Weight gain during pregnancy. This variable will be managed by the midwives through their clinical history. Kilogrames are the unit of this measurement.
Measured: Preintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jul 2022
- Primary completion10 Oct 2022
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iria Da Cuña Carrera, University of Vigo
- Investigators
- Iria Da Cuña-carrera, PHD, Principal investigator, Universitu of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439668
- Sponsor's protocol ID
- 17062022
- Status last verified
- Aug 2023
- First submitted
- 17 Jun 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34356983Carrera 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.
PubMed 31370947Da 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.
PubMed 34210004Mota 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.
PubMed 26304639Lee 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.
PubMed 27363572Soto-Gonzalez M, Da Cuna-Carrera I, Lantaron-Caeiro EM, Pascoal AG. Effect of hypopressive and conventional abdominal exercises on postpartum diastasis recti: A randomized controlled trial. PLoS One. 2024 Dec 12;19(12):e0314274. doi: 10.1371/journal.pone.0314274. eCollection 2024.
PubMed 39666696
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Abdominal Exercise Programs on the Interrect Distance in Postpartum Woman
- ClinicalTrials.gov ID
- NCT05439668
- Acronym / sponsor ID
- 17062022
- Conditions
- Postpartum Period
- Keywords
- Abdominal muscle, Interrectus distance, Abdominal hypopressive exercise, Abdominal crunch exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic abdominal exercises Group | Experimental | Other: Classic abdominal strengthening exercisesThis group will carry out an abdominal strengthening exercise program based on the classic abdominal exercises. |
| Abdominal hypopresives exercise Group | Experimental | Other: Hypopressive abdominal exercises programThis group will carry out an abdominal strengthening exercise program based on the abdominal hypopressives exercises. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women having given birth 8 weeks before starting the study treatment
- Women agree to participate in the study
- Women with vaginal delivery.
Key exclusion criteria (3 listed)
- Women with abdominal hernia
- Pregnancy woman
- Previus Abdominal Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classic abdominal strengthening exercisesClassic abdominal strengthening exercises (Curl-up, sit-ups and leg-rise), balance exercises, general mobility and upper limb strengthening exercises. | Other | Classic abdominal exercises Group |
| Hypopressive abdominal exercises programHypopressive abdominal exercises, balance exercises, general mobility and upper limb strengthening exercises | Other | Abdominal hypopresives exercise Group |
Primary outcome
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.
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.
4 secondary outcomes
Maternal age
Time frame: Preintervention
Fetal weight
Time frame: Preintervenrion
Number of deliveries
Time frame: Preintervention
Weight gain during pregnancy
Time frame: Preintervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 34356983Da 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.
- Background: PubMed 31370947Carrera 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.
- Background: PubMed 34210004Da 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.
- Background: PubMed 26304639Mota 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.
- Background: PubMed 27363572Lee 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.
- Derived from this study: PubMed 39666696Soto-Gonzalez M, Da Cuna-Carrera I, Lantaron-Caeiro EM, Pascoal AG. Effect of hypopressive and conventional abdominal exercises on postpartum diastasis recti: A randomized controlled trial. PLoS One. 2024 Dec 12;19(12):e0314274. doi: 10.1371/journal.pone.0314274. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iria Da Cuña-carrera, PHD principal investigator
Universitu of Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic abdominal strengthening exercises and Hypopressive abdominal exercises program in people with Postpartum Period, run by University of Vigo at 1 site in Spain.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interrectus distance measure (time frame: Baseline, preintervention). The study lists 2 primary outcomes in all. 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 NCT05439668, which also lists 6 linked publications.
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 14 Aug 2023.