Clinical trial NCT04084119: Effect of Hypopressive Exercise Versus General Strengthening in Postpartum Women
Official title: The Effect of Hypopressive Abdominal Exercise Versus General Strengthening Exercise on Abdominopelvic and Lumbar Function in Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Women
Keywords: postpartum
inter-rectus distance
diastasis recti
Lumbar disability
urinary incontinence
pelvic floor
quality of life
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inter-recti distance
timeFrame: pre-intervention
measure: Inter-recti distance
timeFrame: immediately post-intervention
measure: Inter-recti distance
timeFrame: 3-months follow-up
measure: Abdominal and lumbar muscles thickness
timeFrame: pre-intervention
measure: Abdominal and lumbar muscles thickness
timeFrame: immediately post-intervention
measure: Abdominal and lumbar muscles thickness
timeFrame: 3-months follow-up
Secondary outcomes:
measure: Lumbopelvic and abdominal pain
timeFrame: pre-intervention
measure: Lumbopelvic and abdominal pain
timeFrame: immediately post-intervention
measure: Lumbopelvic and abdominal pain
timeFrame: 3-months follow-up
measure: Lumbopelvic and abdominal muscles function
timeFrame: pre-intervention
measure: Lumbopelvic and abdominal muscles function
timeFrame: immediately post-intervention
measure: Lumbopelvic and abdominal muscles function
timeFrame: 3-months follow-up
measure: Lumbar disability
timeFrame: pre-intervention
measure: Lumbar disability
timeFrame: immediately post-intervention
measure: Lumbar disability
timeFrame: 3-months follow-up
measure: Severity of the urinary incontinence
timeFrame: pre-intervention
measure: Severity of the urinary incontinence
timeFrame: immediately post-intervention
measure: Severity of the urinary incontinence
timeFrame: 3-months follow-up
measure: Sexual dysfunction
timeFrame: pre-intervention
measure: Sexual dysfunction
timeFrame: immediately post-intervention
measure: Sexual dysfunction
timeFrame: 3-months follow-up
measure: Self-reported quality of life
timeFrame: pre-intervention
measure: Self-reported quality of life
timeFrame: immediately post-intervention
measure: Self-reported quality of life
timeFrame: 3-months follow-up
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Mercè Balasch i Bernat
Study officials:
affiliation: Department of Physiotherapy. Faculty of Physioltherapy. Universitat de València
name: Mercè B Balasch i Bernat, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: