Effect of Hypopressive Exercise Versus General Strengthening in Postpartum Women

Postpartum Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084119
• Other study ID #: H1545907781766
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: February 15, 2023

Study information

• Verified date: May 2023
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. To evaluate the effects of the interventions, the subjects will be assessed at pre-intervention, immediately post-intervention and at 3-months follow-up.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 15, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postpartum Women

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Mercè Balasch i Bernat	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

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