NCT06599541

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

September 13, 2024

Last Update Submit

September 16, 2024

Conditions

Keywords

Hypopressive ExercisePilatesAbdominal DiastasisPostpartum

Outcome Measures

Primary Outcomes (1)

  • Distance between rectus abdominis.

    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 Outcomes (1)

  • Quality of life

    The scale will be passed at baseline, immediately after the treatment and 12 weeks after the end of treatment.

Study Arms (2)

HE group

EXPERIMENTAL

Participants with AD who are going to perform hypopressive exercises

Behavioral: Hypopressive Exercise

Pilates group

EXPERIMENTAL

Participants with AD who are going to perform pilates exercises.

Behavioral: Pilates Exercise

Interventions

A hypopressive exercise program will be carry out.

HE group

A pilates exercise program will be carry out.

Pilates group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Científico Tecnológico UAH. Av. de León, 3A

Fuenlabrada, Madrid, 28943, Spain

Location

Related Publications (10)

  • Gluppe S, Engh ME, Bo K. What is the evidence for abdominal and pelvic floor muscle training to treat diastasis recti abdominis postpartum? A systematic review with meta-analysis. Braz J Phys Ther. 2021 Nov-Dec;25(6):664-675. doi: 10.1016/j.bjpt.2021.06.006. Epub 2021 Jul 21.

    PMID: 34391661BACKGROUND
  • Liaw LJ, Hsu MJ, Liao CF, Liu MF, Hsu AT. The relationships between inter-recti distance measured by ultrasound imaging and abdominal muscle function in postpartum women: a 6-month follow-up study. J Orthop Sports Phys Ther. 2011 Jun;41(6):435-43. doi: 10.2519/jospt.2011.3507. Epub 2011 Feb 2.

    PMID: 21289454BACKGROUND
  • Mazzarino M, Kerr D, Wajswelner H, Morris ME. Pilates Method for Women's Health: Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2015 Dec;96(12):2231-42. doi: 10.1016/j.apmr.2015.04.005. Epub 2015 Apr 23.

    PMID: 25912668BACKGROUND
  • Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008.

    PMID: 29351646BACKGROUND
  • Mota P, Pascoal AG, Carita AI, Bo K. The Immediate Effects on Inter-rectus Distance of Abdominal Crunch and Drawing-in Exercises During Pregnancy and the Postpartum Period. J Orthop Sports Phys Ther. 2015 Oct;45(10):781-8. doi: 10.2519/jospt.2015.5459. Epub 2015 Aug 24.

    PMID: 26304639BACKGROUND
  • Vicente-Campos D, Sanchez-Jorge S, Terron-Manrique P, Guisard M, Collin M, Castano B, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Chicharro JL, Calvo-Lobo C. The Main Role of Diaphragm Muscle as a Mechanism of Hypopressive Abdominal Gymnastics to Improve Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial. J Clin Med. 2021 Oct 27;10(21):4983. doi: 10.3390/jcm10214983.

    PMID: 34768502BACKGROUND
  • 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.

    PMID: 34779692BACKGROUND
  • Navarro Brazalez B, Sanchez Sanchez B, Prieto Gomez V, De La Villa Polo P, McLean L, Torres Lacomba M. Pelvic floor and abdominal muscle responses during hypopressive exercises in women with pelvic floor dysfunction. Neurourol Urodyn. 2020 Feb;39(2):793-803. doi: 10.1002/nau.24284. Epub 2020 Jan 27.

    PMID: 31985114BACKGROUND
  • Gluppe SB, Ellstrom Engh M, Bo K. Curl-up exercises improve abdominal muscle strength without worsening inter-recti distance in women with diastasis recti abdominis postpartum: a randomised controlled trial. J Physiother. 2023 Jul;69(3):160-167. doi: 10.1016/j.jphys.2023.05.017. Epub 2023 Jun 5.

    PMID: 37286390BACKGROUND
  • Lee N, Bae YH, Fong SSM, Lee WH. Effects of Pilates on inter-recti distance, thickness of rectus abdominis, waist circumference and abdominal muscle endurance in primiparous women. BMC Womens Health. 2023 Nov 27;23(1):626. doi: 10.1186/s12905-023-02775-5.

    PMID: 38008749BACKGROUND

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Adrián Rosales Torrejón, MSc

    University of Alcala

    PRINCIPAL INVESTIGATOR
  • Ana Serrano Imedio, PdH

    University of Alcala

    STUDY DIRECTOR

Central Study Contacts

Adrián Rosales Torrejón, MSc

CONTACT

Ana Serrano Imedio, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations