Abdominal DiastasisAD-HE-PINCT06599541
Efficacy of Hypopressive Exercises Versus Pilates in Women with Abdominal Diastasis in the Postpartum Period: a Randomized Controlled Trial
A study testing Hypopressive Exercise and Pilates Exercise in people with Abdominal Diastasis, run by University of Alcala at 1 site in Spain.
Trial summary
The aim of this study is to compare the effects of two exercise programs in women with abdominal diastasis (AD) during the postpartum. One group will receive hypopressive exercises (HE) and the other will receive pilates exercise. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abdominal Diastasis
- What is being tested?
- Hypopressive Exercise and Pilates Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2024to Jan 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primiparous women over 18 years of age who are within 3 months postpartum.
- AD with values \>2.5 cm in any of the following reference points: 2 cm supraumbilical or 2 cm infraumbilical.
- Vaginal birth.
Who cannot join
- Abdominal or umbilical hernia.
- Previous abdominal surgery.
- Be receiving any other treatment for your AD
Trial locations and contacts
1 site in 1 country.
Ana Serrano Imedio, PhD contact
Spain1 site
Campus Científico Tecnológico UAH. Av. de León, 3A
Fuenlabrada, Madrid, 28943
Adrián Rosales Torrejón, MSc, +34629488253, adrian.rosales@edu.uah.es
About this study
The aim of this study is to compare the effects of two exercise programs in women with abdominal diastasis (AD) during the postpartum. One group will receive hypopressive exercises (HE) and the other will receive pilates exercise. The hypothesis of this study is that the execution of both protocols will offer benefits in the ultrasound values of the AD and in the data collected on the quality of life in the short term and 12 weeks after its completion.
Read the detailed description
Objective: To compare the efficacy of hypopressive exercises (HE) versus pilates exercise in women with abdominal diastasis (AD) during the postpartum, and to know the effects of each of the exercises independently.
Design: Single-blind randomized controlled trial.
Setting: Faculty of Physical Therapy of Alcalá de Henares (UAH).
Participants: Primiparous women with DA who have vaginal delivery and are in the 3 months postpartum (N=40).
Interventions: Participants will be randomly assigned to perform either a HE program focused on freediving work (n=20) or a pilates program focused on exhalation (n=20). The intervention will consist of 3 weekly sessions lasting 30 minutes over 12 weeks, where they will receive a weekly face-to-face and group session and two home sessions.
Main outcome measures: The primary outcome will be measurement of the distance between rectus abdominis through ultrasound to be assessed at baseline, immediately after the intervention and 12 weeks later. The secondary outcome measure will correspond to the measurement of quality of life using the SF-36 Health Questionnaire. It will be collected through masked evaluations by 2 physiotherapists at baseline, at the end of the intervention and at 12 weeks.
- Conditions
- Abdominal Diastasis
- Being tested
- Hypopressive Exercise, Pilates Exercise
- Keywords
- Hypopressive Exercise, Pilates, Abdominal Diastasis, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypopressive ExerciseBehavioural
A hypopressive exercise program will be carry out.
Pilates ExerciseBehavioural
A pilates exercise program will be carry out.
| Study group | Role | What they receive |
|---|---|---|
| HE group | Experimental | Participants with AD who are going to perform hypopressive exercises Receives: Behavioral: Hypopressive Exercise |
| Pilates group | Experimental | Participants with AD who are going to perform pilates exercises. Receives: Behavioral: Pilates Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between rectus abdominis.
The distance between both muscle bellies of the rectus abdominis will be measured with an ultrasound (linear probe). It will be measured at two reference points: 2 cm supraumbilical and 2 cm infraumbilical.
Measured: The measurements will be collected at baseline, immediately after the treatment and 12 weeks after the end of treatment.
Secondary outcomes (1)
Quality of life
The SF-36 consists of a health questionnaire composed of 36 items for the characterization of a person´s health. The total score ranges between 0 and 100 points. A higher score reflects more optimal health.
Measured: The scale will be passed at baseline, immediately after the treatment and 12 weeks after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Abdominal DiastasisStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Rosales Torrejón, University of Alcala
- Investigators
- Adrián Rosales Torrejón, MSc, Principal investigator, University of AlcalaAna Serrano Imedio, PdH, Study director, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599541
- Sponsor's protocol ID
- Abdominal diastasis
- Acronym
- AD-HE-PI
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gluppe S, Engh ME, Bo K. What is the evidence for abdominal and pelvic floor muscle training to treat diastasis recti abdominis postpartum? A systematic review with meta-analysis. Braz J Phys Ther. 2021 Nov-Dec;25(6):664-675. doi: 10.1016/j.bjpt.2021.06.006. Epub 2021 Jul 21.
PubMed 34391661Liaw LJ, Hsu MJ, Liao CF, Liu MF, Hsu AT. The relationships between inter-recti distance measured by ultrasound imaging and abdominal muscle function in postpartum women: a 6-month follow-up study. J Orthop Sports Phys Ther. 2011 Jun;41(6):435-43. doi: 10.2519/jospt.2011.3507. Epub 2011 Feb 2.
PubMed 21289454Mazzarino M, Kerr D, Wajswelner H, Morris ME. Pilates Method for Women's Health: Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2015 Dec;96(12):2231-42. doi: 10.1016/j.apmr.2015.04.005. Epub 2015 Apr 23.
PubMed 25912668Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008.
PubMed 29351646Mota 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 26304639Vicente-Campos D, Sanchez-Jorge S, Terron-Manrique P, Guisard M, Collin M, Castano B, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Chicharro JL, Calvo-Lobo C. The Main Role of Diaphragm Muscle as a Mechanism of Hypopressive Abdominal Gymnastics to Improve Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial. J Clin Med. 2021 Oct 27;10(21):4983. doi: 10.3390/jcm10214983.
PubMed 34768502Ramirez-Jimenez M, Alburquerque-Sendin F, Garrido-Castro JL, Rodrigues-de-Souza D. Effects of hypopressive exercises on post-partum abdominal diastasis, trunk circumference, and mechanical properties of abdominopelvic tissues: a case series. Physiother Theory Pract. 2023 Jan;39(1):49-60. doi: 10.1080/09593985.2021.2004630. Epub 2021 Nov 15.
PubMed 34779692Navarro Brazalez B, Sanchez Sanchez B, Prieto Gomez V, De La Villa Polo P, McLean L, Torres Lacomba M. Pelvic floor and abdominal muscle responses during hypopressive exercises in women with pelvic floor dysfunction. Neurourol Urodyn. 2020 Feb;39(2):793-803. doi: 10.1002/nau.24284. Epub 2020 Jan 27.
PubMed 31985114Gluppe SB, Ellstrom Engh M, Bo K. Curl-up exercises improve abdominal muscle strength without worsening inter-recti distance in women with diastasis recti abdominis postpartum: a randomised controlled trial. J Physiother. 2023 Jul;69(3):160-167. doi: 10.1016/j.jphys.2023.05.017. Epub 2023 Jun 5.
PubMed 37286390Lee N, Bae YH, Fong SSM, Lee WH. Effects of Pilates on inter-recti distance, thickness of rectus abdominis, waist circumference and abdominal muscle endurance in primiparous women. BMC Womens Health. 2023 Nov 27;23(1):626. doi: 10.1186/s12905-023-02775-5.
PubMed 38008749
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hypopressive Exercises Versus Pilates in Women with Abdominal Diastasis in the Postpartum Period: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06599541
- Acronym / sponsor ID
- AD-HE-PI / Abdominal diastasis
- Conditions
- Abdominal Diastasis
- Keywords
- Hypopressive Exercise, Pilates, Abdominal Diastasis, Postpartum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Sep 2024 (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 aim of this study is to compare the effects of two exercise programs in women with abdominal diastasis (AD) during the postpartum. One group will receive hypopressive exercises (HE) and the other will receive pilates exercise. The hypothesis of this study is that the execution of both protocols will offer benefits in the ultrasound values of the AD and in the data collected on the quality of life in the short term and 12 weeks after its completion.
Detailed description
Objective: To compare the efficacy of hypopressive exercises (HE) versus pilates exercise in women with abdominal diastasis (AD) during the postpartum, and to know the effects of each of the exercises independently.
Design: Single-blind randomized controlled trial.
Setting: Faculty of Physical Therapy of Alcalá de Henares (UAH).
Participants: Primiparous women with DA who have vaginal delivery and are in the 3 months postpartum (N=40).
Interventions: Participants will be randomly assigned to perform either a HE program focused on freediving work (n=20) or a pilates program focused on exhalation (n=20). The intervention will consist of 3 weekly sessions lasting 30 minutes over 12 weeks, where they will receive a weekly face-to-face and group session and two home sessions.
Main outcome measures: The primary outcome will be measurement of the distance between rectus abdominis through ultrasound to be assessed at baseline, immediately after the intervention and 12 weeks later. The secondary outcome measure will correspond to the measurement of quality of life using the SF-36 Health Questionnaire. It will be collected through masked evaluations by 2 physiotherapists at baseline, at the end of the intervention and at 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HE group | Experimental | Behavioral: Hypopressive ExerciseParticipants with AD who are going to perform hypopressive exercises |
| Pilates group | Experimental | Behavioral: Pilates ExerciseParticipants with AD who are going to perform pilates exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primiparous women over 18 years of age who are within 3 months postpartum.
- AD with values \>2.5 cm in any of the following reference points: 2 cm supraumbilical or 2 cm infraumbilical.
- Vaginal birth.
Key exclusion criteria (3 listed)
- Abdominal or umbilical hernia.
- Previous abdominal surgery.
- Be receiving any other treatment for your AD
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 |
|---|---|---|
| Hypopressive ExerciseA hypopressive exercise program will be carry out. | Behavioural | HE group |
| Pilates ExerciseA pilates exercise program will be carry out. | Behavioural | Pilates group |
Primary outcome
Distance between rectus abdominis.
Time frame: The measurements will be collected at baseline, immediately after the treatment and 12 weeks after the end of treatment.
The distance between both muscle bellies of the rectus abdominis will be measured with an ultrasound (linear probe). It will be measured at two reference points: 2 cm supraumbilical and 2 cm infraumbilical.
1 secondary outcome
Quality of life
Time frame: The scale will be passed at baseline, immediately after the treatment and 12 weeks after the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 34391661Gluppe S, Engh ME, Bo K. What is the evidence for abdominal and pelvic floor muscle training to treat diastasis recti abdominis postpartum? A systematic review with meta-analysis. Braz J Phys Ther. 2021 Nov-Dec;25(6):664-675. doi: 10.1016/j.bjpt.2021.06.006. Epub 2021 Jul 21.
- Background: PubMed 21289454Liaw LJ, Hsu MJ, Liao CF, Liu MF, Hsu AT. The relationships between inter-recti distance measured by ultrasound imaging and abdominal muscle function in postpartum women: a 6-month follow-up study. J Orthop Sports Phys Ther. 2011 Jun;41(6):435-43. doi: 10.2519/jospt.2011.3507. Epub 2011 Feb 2.
- Background: PubMed 25912668Mazzarino M, Kerr D, Wajswelner H, Morris ME. Pilates Method for Women's Health: Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2015 Dec;96(12):2231-42. doi: 10.1016/j.apmr.2015.04.005. Epub 2015 Apr 23.
- Background: PubMed 29351646Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008.
- 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 34768502Vicente-Campos D, Sanchez-Jorge S, Terron-Manrique P, Guisard M, Collin M, Castano B, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Chicharro JL, Calvo-Lobo C. The Main Role of Diaphragm Muscle as a Mechanism of Hypopressive Abdominal Gymnastics to Improve Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial. J Clin Med. 2021 Oct 27;10(21):4983. doi: 10.3390/jcm10214983.
- Background: PubMed 34779692Ramirez-Jimenez M, Alburquerque-Sendin F, Garrido-Castro JL, Rodrigues-de-Souza D. Effects of hypopressive exercises on post-partum abdominal diastasis, trunk circumference, and mechanical properties of abdominopelvic tissues: a case series. Physiother Theory Pract. 2023 Jan;39(1):49-60. doi: 10.1080/09593985.2021.2004630. Epub 2021 Nov 15.
- Background: PubMed 31985114Navarro Brazalez B, Sanchez Sanchez B, Prieto Gomez V, De La Villa Polo P, McLean L, Torres Lacomba M. Pelvic floor and abdominal muscle responses during hypopressive exercises in women with pelvic floor dysfunction. Neurourol Urodyn. 2020 Feb;39(2):793-803. doi: 10.1002/nau.24284. Epub 2020 Jan 27.
- Background: PubMed 37286390Gluppe SB, Ellstrom Engh M, Bo K. Curl-up exercises improve abdominal muscle strength without worsening inter-recti distance in women with diastasis recti abdominis postpartum: a randomised controlled trial. J Physiother. 2023 Jul;69(3):160-167. doi: 10.1016/j.jphys.2023.05.017. Epub 2023 Jun 5.
- Background: PubMed 38008749Lee N, Bae YH, Fong SSM, Lee WH. Effects of Pilates on inter-recti distance, thickness of rectus abdominis, waist circumference and abdominal muscle endurance in primiparous women. BMC Womens Health. 2023 Nov 27;23(1):626. doi: 10.1186/s12905-023-02775-5.
- 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.
Ana Serrano Imedio, PhD contact
Adrián Rosales Torrejón, MSc principal investigator
University of Alcala
Ana Serrano Imedio, PdH study director
University of Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypopressive Exercise and Pilates Exercise in people with Abdominal Diastasis, run by University of Alcala 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrián Rosales Torrejón, MSc (+34629488253, adrian.rosales@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between rectus abdominis. (time frame: The measurements will be collected at baseline, immediately after the treatment and 12 weeks after the end of treatment.). 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 NCT06599541, which also lists 10 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 19 Sep 2024.