Effect of Hypopressive Exercise Versus General Strengthening in Postpartum Women

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Women
• Intervention / Treatment: Other: hypopressive abdominal exercise; Other: general strengthening exercise

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Mercè Balasch i Bernat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Mercè B Balasch i Bernat, PhD, PT, Department of Physiotherapy. Faculty of Physioltherapy. Universitat de València

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: May 25, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; postpartum; urinary incontinence; pelvic floor; diastasis recti; inter-rectus distance; Lumbar disability
• Other Study ID Numbers: H1545907781766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No