Postpartum WomenNCT04084119
Effect of Hypopressive Exercise Versus General Strengthening in Postpartum Women
A study testing hypopressive abdominal exercise and general strengthening exercise in people with Postpartum Women, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of this study is to compare the effect of a hypopressive abdominal exercise program versus a general strengthening exercise program on inter-recti distance, abdominal and lumbar muscle thickness, lumbopelvic and abdominal pain and function, pelvic floor dysfunction, and quality of life in postpartum women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Women
- What is being tested?
- hypopressive abdominal exercise and general strengthening exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2018to 15 Feb 2023
- 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
- women aged between 18-45 years old
- in the 6th-8th week postpartum
- both vaginal or caesarean delivery
- both primiparous or multiparous women
Who cannot join
- previous abdominal or pelvic surgery
- reasons to suspect metabolic, neurological or neuromuscular disease
- multiple birth delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hypopressive Abdominal Exercise Versus General Strengthening Exercise on Abdominopelvic and Lumbar Function in Postpartum Women
The aim of this study is to compare the effect of a hypopressive abdominal exercise program versus a general strengthening exercise program on inter-recti distance, abdominal and lumbar muscle thickness, lumbopelvic and abdominal pain and function, pelvic floor dysfunction, and quality of life in postpartum women. To evaluate the effects of the interventions, the subjects will be assessed at pre-intervention, immediately post-intervention and at 3-months follow-up.
Read the detailed description
The aim of this study is to compare the effect of a hypopressive abdominal exercise program versus a general strengthening exercise program on inter-recti distance, abdominal and lumbar muscle thickness, lumbopelvic and abdominal pain and function, pelvic floor dysfunction, and quality of life in postpartum women. To evaluate the effects of the hypopressive exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and at 3-months follow-up.
It will consist of a randomized controlled trial study. The sample will consist of women in the early postpartum period (6-8 weeks after delivery). Subjects will be randomly allocated to two different exercise programs: hypopressive abdominal exercise program and general strengthening exercise program. Both interventions will have a total duration of 6 weeks (18 sessions), 3 times a week, 30 minutes each session.
To evaluate the effects of the interventions, the subjects will be assessed at pre-intervention (6th-8th week postpartum), immediately post-intervention (12th-14th week postpartum) and at 3-months follow-up (24th-26th week postpartum). Inter-recti distance, abdominal and lumbar muscle thickness, lumbopelvic and abdominal pain and function, pelvic floor dysfunction, and quality of life will be measured.
- Conditions
- Postpartum Women
- Being tested
- hypopressive abdominal exercise, general strengthening exercise
- Keywords
- postpartum, inter-rectus distance, diastasis recti, Lumbar disability, urinary incontinence, pelvic floor, quality of life
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypopressive abdominal exerciseOther
Participants will perform an hypopressive abdominal exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session.
general strengthening exerciseOther
Participants will perform a general strengthening exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session.
| Study group | Role | What they receive |
|---|---|---|
| hypopressive abdominal exercise | Experimental | Participants will perform an hypopressive abdominal exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session. Receives: Other: hypopressive abdominal exercise |
| general strengthening exercise | Active comparator | Participants will perform a general strengthening exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session. Receives: Other: general strengthening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-recti distance
Inter-recti distance will be measured by ultrasonography at rest, during abdominal draw-in and abdominal curl-up, at 2 locations on the linea alba (2 cm above and below the umbilicus).
Measured: pre-intervention
Inter-recti distance
Inter-recti distance will be measured by ultrasonography at rest, during abdominal draw-in and abdominal curl-up, at 2 locations on the linea alba (2 cm above and below the umbilicus).
Measured: immediately post-intervention
Inter-recti distance
Inter-recti distance will be measured by ultrasonography at rest, during abdominal draw-in and abdominal curl-up, at 2 locations on the linea alba (2 cm above and below the umbilicus).
Measured: 3-months follow-up
Abdominal and lumbar muscles thickness
Transversus abdominis, obliquus internus, obliquus externus and multifidus thickness at rest and during draw-in will be measured by ultrasonography.
Measured: pre-intervention
Abdominal and lumbar muscles thickness
Transversus abdominis, obliquus internus, obliquus externus and multifidus thickness at rest and during draw-in will be measured by ultrasonography.
Measured: immediately post-intervention
Abdominal and lumbar muscles thickness
Transversus abdominis, obliquus internus, obliquus externus and multifidus thickness at rest and during draw-in will be measured by ultrasonography.
Measured: 3-months follow-up
Secondary outcomes (18)
Lumbopelvic and abdominal pain
Lumbopelvic and abdominal pain reported by the patient will be measured using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Lower values represent a better outcome (less pain).
Measured: pre-intervention
Lumbopelvic and abdominal pain
Lumbopelvic and abdominal pain reported by the patient will be measured using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Lower values represent a better outcome (less pain).
Measured: immediately post-intervention
Lumbopelvic and abdominal pain
Lumbopelvic and abdominal pain reported by the patient will be measured using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Lower values represent a better outcome (less pain).
Measured: 3-months follow-up
Lumbopelvic and abdominal muscles function
Lumbopelvic and abdominal muscles function will be tested with the supine bridge test, the prone bridge test and the lateral bridge test.
Measured: pre-intervention
Lumbopelvic and abdominal muscles function
Lumbopelvic and abdominal muscles function will be tested with the supine bridge test, the prone bridge test and the lateral bridge test.
Measured: immediately post-intervention
Lumbopelvic and abdominal muscles function
Lumbopelvic and abdominal muscles function will be tested with the supine bridge test, the prone bridge test and the lateral bridge test.
Measured: 3-months follow-up
Lumbar disability
Lumbar disability will be evaluated by the Oswestry Disability Index (ODI)
Measured: pre-intervention
Lumbar disability
Lumbar disability will be evaluated by the Oswestry Disability Index (ODI)
Measured: immediately post-intervention
Lumbar disability
Lumbar disability will be evaluated by the Oswestry Disability Index (ODI)
Measured: 3-months follow-up
Severity of the urinary incontinence
The severity of the urinary incontinence will be assessed using the Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-IU-SF) (0-21).
Measured: pre-intervention
Severity of the urinary incontinence
The severity of the urinary incontinence will be assessed using the Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-IU-SF) (0-21).
Measured: immediately post-intervention
Severity of the urinary incontinence
The severity of the urinary incontinence will be assessed using the Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-IU-SF) (0-21).
Measured: 3-months follow-up
Sexual dysfunction
Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30).
Measured: pre-intervention
Sexual dysfunction
Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30).
Measured: immediately post-intervention
Sexual dysfunction
Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30).
Measured: 3-months follow-up
Self-reported quality of life
Self-reported quality of life will be evaluated with the Short Form-36 Health Survey (SF-36). In this scale, higher scores indicate higher quality of life.
Measured: pre-intervention
Self-reported quality of life
Self-reported quality of life will be evaluated with the Short Form-36 Health Survey (SF-36). In this scale, higher scores indicate higher quality of life.
Measured: immediately post-intervention
Self-reported quality of life
Self-reported quality of life will be evaluated with the Short Form-36 Health Survey (SF-36). In this scale, higher scores indicate higher quality of life.
Measured: 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Nov 2018
- Primary completion30 Dec 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercè Balasch i Bernat, University of Valencia
- Investigators
- Mercè B Balasch i Bernat, PhD, PT, Principal investigator, Department of Physiotherapy. Faculty of Physioltherapy. Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084119
- Sponsor's protocol ID
- H1545907781766
- Status last verified
- May 2023
- First submitted
- 25 May 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypopressive Abdominal Exercise Versus General Strengthening Exercise on Abdominopelvic and Lumbar Function in Postpartum Women
- ClinicalTrials.gov ID
- NCT04084119
- Acronym / sponsor ID
- H1545907781766
- Conditions
- Postpartum Women
- Keywords
- postpartum, inter-rectus distance, diastasis recti, Lumbar disability, urinary incontinence, pelvic floor, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 10 Sep 2019 (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 effect of a hypopressive abdominal exercise program versus a general strengthening exercise program on inter-recti distance, abdominal and lumbar muscle thickness, lumbopelvic and abdominal pain and function, pelvic floor dysfunction, and quality of life in postpartum women. To evaluate the effects of the interventions, the subjects will be assessed at pre-intervention, immediately post-intervention and at 3-months follow-up.
Detailed description
The aim of this study is to compare the effect of a hypopressive abdominal exercise program versus a general strengthening exercise program on inter-recti distance, abdominal and lumbar muscle thickness, lumbopelvic and abdominal pain and function, pelvic floor dysfunction, and quality of life in postpartum women. To evaluate the effects of the hypopressive exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and at 3-months follow-up.
It will consist of a randomized controlled trial study. The sample will consist of women in the early postpartum period (6-8 weeks after delivery). Subjects will be randomly allocated to two different exercise programs: hypopressive abdominal exercise program and general strengthening exercise program. Both interventions will have a total duration of 6 weeks (18 sessions), 3 times a week, 30 minutes each session.
To evaluate the effects of the interventions, the subjects will be assessed at pre-intervention (6th-8th week postpartum), immediately post-intervention (12th-14th week postpartum) and at 3-months follow-up (24th-26th week postpartum). Inter-recti distance, abdominal and lumbar muscle thickness, lumbopelvic and abdominal pain and function, pelvic floor dysfunction, and quality of life will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypopressive abdominal exercise | Experimental | Other: hypopressive abdominal exerciseParticipants will perform an hypopressive abdominal exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session. |
| general strengthening exercise | Active comparator | Other: general strengthening exerciseParticipants will perform a general strengthening exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women aged between 18-45 years old
- in the 6th-8th week postpartum
- both vaginal or caesarean delivery
- both primiparous or multiparous women
Key exclusion criteria (3 listed)
- previous abdominal or pelvic surgery
- reasons to suspect metabolic, neurological or neuromuscular disease
- multiple birth delivery
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 abdominal exerciseParticipants will perform an hypopressive abdominal exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session. | Other | hypopressive abdominal exercise |
| general strengthening exerciseParticipants will perform a general strengthening exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session. | Other | general strengthening exercise |
Primary outcome
Inter-recti distance
Time frame: pre-intervention
Inter-recti distance will be measured by ultrasonography at rest, during abdominal draw-in and abdominal curl-up, at 2 locations on the linea alba (2 cm above and below the umbilicus).
Inter-recti distance
Time frame: immediately post-intervention
Inter-recti distance will be measured by ultrasonography at rest, during abdominal draw-in and abdominal curl-up, at 2 locations on the linea alba (2 cm above and below the umbilicus).
Inter-recti distance
Time frame: 3-months follow-up
Inter-recti distance will be measured by ultrasonography at rest, during abdominal draw-in and abdominal curl-up, at 2 locations on the linea alba (2 cm above and below the umbilicus).
Abdominal and lumbar muscles thickness
Time frame: pre-intervention
Transversus abdominis, obliquus internus, obliquus externus and multifidus thickness at rest and during draw-in will be measured by ultrasonography.
Abdominal and lumbar muscles thickness
Time frame: immediately post-intervention
Transversus abdominis, obliquus internus, obliquus externus and multifidus thickness at rest and during draw-in will be measured by ultrasonography.
Abdominal and lumbar muscles thickness
Time frame: 3-months follow-up
Transversus abdominis, obliquus internus, obliquus externus and multifidus thickness at rest and during draw-in will be measured by ultrasonography.
18 secondary outcomes
Lumbopelvic and abdominal pain
Time frame: pre-intervention
Lumbopelvic and abdominal pain
Time frame: immediately post-intervention
Lumbopelvic and abdominal pain
Time frame: 3-months follow-up
Lumbopelvic and abdominal muscles function
Time frame: pre-intervention
Lumbopelvic and abdominal muscles function
Time frame: immediately post-intervention
Lumbopelvic and abdominal muscles function
Time frame: 3-months follow-up
Lumbar disability
Time frame: pre-intervention
Lumbar disability
Time frame: immediately post-intervention
Lumbar disability
Time frame: 3-months follow-up
Severity of the urinary incontinence
Time frame: pre-intervention
Severity of the urinary incontinence
Time frame: immediately post-intervention
Severity of the urinary incontinence
Time frame: 3-months follow-up
Sexual dysfunction
Time frame: pre-intervention
Sexual dysfunction
Time frame: immediately post-intervention
Sexual dysfunction
Time frame: 3-months follow-up
Self-reported quality of life
Time frame: pre-intervention
Self-reported quality of life
Time frame: immediately post-intervention
Self-reported quality of life
Time frame: 3-months follow-up
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 9 May 2023.
- Individual participant dataSharing planned: No
Related trials for Postpartum Women
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Mercè B Balasch i Bernat, PhD, PT principal investigator
Department of Physiotherapy. Faculty of Physioltherapy. Universitat de València
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 abdominal exercise and general strengthening exercise in people with Postpartum Women, run by University of Valencia 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 4 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 9 May 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?
Inter-recti distance (time frame: pre-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.