Effect of Hypopressive Exercise Versus General Strengthening in Postpartum Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Hypopressive Abdominal Exercise Versus General Strengthening Exercise on Abdominopelvic and Lumbar Function in Postpartum Women

Conditions
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Postpartum Women

Intervention / Treatment
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* Other: hypopressive abdominal exercise
* Other: general strengthening exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged between 18-45 years old in the 6th-8th week postpartum both vaginal or caesarean delivery both primiparous or multiparous women Exclusion Criteria: previous abdominal or pelvic surgery reasons to suspect metabolic, neurological or neuromuscular disease multiple birth delivery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypopressive abdominal exercise<br>Participants 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<br>* Participants will perform an hypopressive abdominal exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session.<br>|
| Active Comparator: general strengthening exercise<br>Participants 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<br>* Participants will perform a general strengthening exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | 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. | 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. | 3-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | 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. | 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. | 3-months follow-up | 
| Lumbar disability | Lumbar disability will be evaluated by the Oswestry Disability Index (ODI) | pre-intervention | 
| Lumbar disability | Lumbar disability will be evaluated by the Oswestry Disability Index (ODI) | immediately post-intervention | 
| Lumbar disability | Lumbar disability will be evaluated by the Oswestry Disability Index (ODI) | 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). | 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). | 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). | 3-months follow-up | 
| Sexual dysfunction | Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30). | pre-intervention | 
| Sexual dysfunction | Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30). | immediately post-intervention | 
| Sexual dysfunction | Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30). | 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. | 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. | 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. | 3-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum, inter-rectus distance, diastasis recti, Lumbar disability, urinary incontinence, pelvic floor, quality of life