Effect of Hypopressive Exercise Versus General Strengthening in Postpartum Women

NCT04084119 | Completed

• 1 other identifier: H1545907781766
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Women

Keywords

postpartum; inter-rectus distance; diastasis recti; Lumbar disability; urinary incontinence; pelvic floor; quality of life

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (18)

• Lumbopelvic and abdominal pain

  pre-intervention

• Lumbopelvic and abdominal pain

  immediately post-intervention

• Lumbopelvic and abdominal pain

  3-months follow-up

• Lumbopelvic and abdominal muscles function

  pre-intervention

• Lumbopelvic and abdominal muscles function

  immediately post-intervention

Study Arms (2)

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.

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.

Other: general strengthening exercise

Interventions

hypopressive abdominal exercise OTHER

Participants will perform an hypopressive abdominal exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session.

hypopressive abdominal exercise

general strengthening exercise OTHER

Participants will perform a general strengthening exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session.

general strengthening exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged between 18-45 years old
• in the 6th-8th week postpartum
• both vaginal or caesarean delivery
• both primiparous or multiparous women

You may not qualify if:

• previous abdominal or pelvic surgery
• reasons to suspect metabolic, neurological or neuromuscular disease
• multiple birth delivery

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Mercè Balasch i Bernat

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mercè B Balasch i Bernat, PhD, PT

  Department of Physiotherapy. Faculty of Physioltherapy. Universitat de València

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants don't know to which intervention group they belong to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: May 25, 2019
• First Posted: September 10, 2019
• Study Start: November 1, 2018
• Primary Completion: December 30, 2022
• Study Completion: February 15, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)