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Completed

NCT Number: NCT04084119

Effect of Hypopressive Exercise Versus General Strengthening 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mercè Balasch i Bernat

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Lumbopelvic and abdominal pain

    Time frame: pre-intervention

    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).

  2. Lumbopelvic and abdominal pain

    Time frame: immediately post-intervention

    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. Lumbopelvic and abdominal pain

    Time frame: 3-months follow-up

    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).

  4. Lumbopelvic and abdominal muscles function

    Time frame: pre-intervention

    Lumbopelvic and abdominal muscles function will be tested with the supine bridge test, the prone bridge test and the lateral bridge test.

  5. Lumbopelvic and abdominal muscles function

    Time frame: immediately post-intervention

    Lumbopelvic and abdominal muscles function will be tested with the supine bridge test, the prone bridge test and the lateral bridge test.

  6. Lumbopelvic and abdominal muscles function

    Time frame: 3-months follow-up

    Lumbopelvic and abdominal muscles function will be tested with the supine bridge test, the prone bridge test and the lateral bridge test.

  7. Lumbar disability

    Time frame: pre-intervention

    Lumbar disability will be evaluated by the Oswestry Disability Index (ODI)

  8. Lumbar disability

    Time frame: immediately post-intervention

    Lumbar disability will be evaluated by the Oswestry Disability Index (ODI)

  9. Lumbar disability

    Time frame: 3-months follow-up

    Lumbar disability will be evaluated by the Oswestry Disability Index (ODI)

  10. Severity of the urinary incontinence

    Time frame: pre-intervention

    The severity of the urinary incontinence will be assessed using the Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-IU-SF) (0-21).

  11. Severity of the urinary incontinence

    Time frame: immediately post-intervention

    The severity of the urinary incontinence will be assessed using the Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-IU-SF) (0-21).

  12. Severity of the urinary incontinence

    Time frame: 3-months follow-up

    The severity of the urinary incontinence will be assessed using the Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-IU-SF) (0-21).

  13. Sexual dysfunction

    Time frame: pre-intervention

    Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30).

  14. Sexual dysfunction

    Time frame: immediately post-intervention

    Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30).

  15. Sexual dysfunction

    Time frame: 3-months follow-up

    Sexual dysfunction will be assessed using the 6-item Female Sexual Function Index (FSFI-6) (5-30).

  16. Self-reported quality of life

    Time frame: pre-intervention

    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.

  17. Self-reported quality of life

    Time frame: immediately post-intervention

    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.

  18. Self-reported quality of life

    Time frame: 3-months follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Sep 10, 2019
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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