Clinical trial NCT06599541: Efficacy of Hypopressive Exercises Versus Pilates in Women with Abdominal Diastasis in the Postpartum Period: a Randomized Controlled Trial
Official title: Efficacy of Hypopressive Exercises Versus Pilates in Women with Abdominal Diastasis in the Postpartum Period: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Diastasis
Keywords: Hypopressive Exercise
Pilates
Abdominal Diastasis
Postpartum
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 48
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 effects of two exercise programs in women with abdominal diastasis (AD) during the postpartum. One group will receive hypopressive exercises (HE) and the other will receive pilates exercise. The hypothesis of this study is that the execution of both protocols will offer benefits in the ultrasound values of the AD and in the data collected on the quality of life in the short term and 12 weeks after its completion.

Detailed description: Objective: To compare the efficacy of hypopressive exercises (HE) versus pilates exercise in women with abdominal diastasis (AD) during the postpartum, and to know the effects of each of the exercises independently.

Design: Single-blind randomized controlled trial.

Setting: Faculty of Physical Therapy of Alcalá de Henares (UAH).

Participants: Primiparous women with DA who have vaginal delivery and are in the 3 months postpartum (N=40).

Interventions: Participants will be randomly assigned to perform either a HE program focused on freediving work (n=20) or a pilates program focused on exhalation (n=20). The intervention will consist of 3 weekly sessions lasting 30 minutes over 12 weeks, where they will receive a weekly face-to-face and group session and two home sessions.

Main outcome measures: The primary outcome will be measurement of the distance between rectus abdominis through ultrasound to be assessed at baseline, immediately after the intervention and 12 weeks later. The secondary outcome measure will correspond to the measurement of quality of life using the SF-36 Health Questionnaire. It will be collected through masked evaluations by 2 physiotherapists at baseline, at the end of the intervention and at 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Primiparous women over 18 years of age who are within 3 months postpartum.
* AD with values \&amp;gt;2.5 cm in any of the following reference points: 2 cm supraumbilical or 2 cm infraumbilical.
* Vaginal birth.

Exclusion Criteria:

* Abdominal or umbilical hernia.
* Previous abdominal surgery.
* Be receiving any other treatment for your AD

Primary outcomes:
measure: Distance between rectus abdominis.
timeFrame: The measurements will be collected at baseline, immediately after the treatment and 12 weeks after the end of treatment.
Secondary outcomes:
measure: Quality of life
timeFrame: The scale will be passed at baseline, immediately after the treatment and 12 weeks after the end of treatment.
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Campus Científico Tecnológico UAH. Av. de León, 3A
state: Madrid
Study officials:
affiliation: University of Alcala
name: Adrián Rosales Torrejón, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alcala
name: Ana Serrano Imedio, PdH
role: STUDY_DIRECTOR
References:
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citation: Ramirez-Jimenez M, Alburquerque-Sendin F, Garrido-Castro JL, Rodrigues-de-Souza D. Effects of hypopressive exercises on post-partum abdominal diastasis, trunk circumference, and mechanical properties of abdominopelvic tissues: a case series. Physiother Theory Pract. 2023 Jan;39(1):49-60. doi: 10.1080/09593985.2021.2004630. Epub 2021 Nov 15.
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