Efficacy of Hypopressive Exercises Versus Pilates in Women with Abdominal Diastasis in the Postpartum Period: a Randomized Controlled Trial (AD-HE-PI)

September 16, 2024 updated by: Adrián Rosales Torrejón, University of Alcala
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28943
        • Campus Científico Tecnológico UAH. Av. de León, 3A
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primiparous women over 18 years of age who are within 3 months postpartum.
  • AD with values >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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HE group
Participants with AD who are going to perform hypopressive exercises
Behavioral: Hypopressive Exercise
A hypopressive exercise program will be carry out.
Experimental: Pilates group
Participants with AD who are going to perform pilates exercises.
Behavioral: Pilates Exercise
A pilates exercise program will be carry out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance between rectus abdominis.
Time Frame: The measurements will be collected at baseline, immediately after the treatment and 12 weeks after the end of treatment.
The distance between both muscle bellies of the rectus abdominis will be measured with an ultrasound (linear probe). It will be measured at two reference points: 2 cm supraumbilical and 2 cm infraumbilical.
The measurements will be collected at baseline, immediately after the treatment and 12 weeks after the end of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: The scale will be passed at baseline, immediately after the treatment and 12 weeks after the end of treatment.
The SF-36 consists of a health questionnaire composed of 36 items for the characterization of a person´s health. The total score ranges between 0 and 100 points. A higher score reflects more optimal health.
The scale will be passed at baseline, immediately after the treatment and 12 weeks after the end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Adrián Rosales Torrejón, MSc, University of Alcala
  • Study Director: Ana Serrano Imedio, PdH, University of Alcala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Abdominal diastasis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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