NCT05439668

Brief Summary

The objective of the research is to compare two programs of exercises in postpartum woman, one based in abdominal strengthening exercises and the other based in abdominal hypopresive exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 17, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

June 17, 2022

Last Update Submit

August 11, 2023

Conditions

Keywords

Abdominal muscleInterrectus distanceAbdominal hypopressive exerciseAbdominal crunch exercise

Outcome Measures

Primary Outcomes (2)

  • Interrectus distance measure

    he participants will be placed in supine decubitus with the knees flexed to 90º with the feet resting on the stretcher and the arms along the body. After receiving the instructions to perform an abdominal crunch, subjects are asked to lift their heads and lift shoulders until the scapula lifts off the table. The ultrasound images will be recorded with an ultrasound scanner (GE Logic and; 4 12MHz, 39mm linear transducer; mode B), in a position of supine rest and a position of muscle activation (isometric contraction), 2 cm and 5 cm above the navel. Centimeters are the unit of measurement.

    Baseline, preintervention

  • Interrectus distance measure

    he participants will be placed in supine decubitus with the knees flexed to 90º with the feet resting on the stretcher and the arms along the body. After receiving the instructions to perform an abdominal crunch, subjects are asked to lift their heads and lift shoulders until the scapula lifts off the table. The ultrasound images will be recorded with an ultrasound scanner (GE Logic and; 4 12MHz, 39mm linear transducer; mode B), in a position of supine rest and a position of muscle activation (isometric contraction), 2 cm and 5 cm above the navel. Centimeters are the unit of this measurement.

    After the intervention

Secondary Outcomes (4)

  • Maternal age

    Preintervention

  • Fetal weight

    Preintervenrion

  • Number of deliveries

    Preintervention

  • Weight gain during pregnancy

    Preintervention

Study Arms (2)

Classic abdominal exercises Group

EXPERIMENTAL

This group will carry out an abdominal strengthening exercise program based on the classic abdominal exercises.

Other: Classic abdominal strengthening exercises

Abdominal hypopresives exercise Group

EXPERIMENTAL

This group will carry out an abdominal strengthening exercise program based on the abdominal hypopressives exercises.

Other: Hypopressive abdominal exercises program

Interventions

Classic abdominal strengthening exercises (Curl-up, sit-ups and leg-rise), balance exercises, general mobility and upper limb strengthening exercises.

Classic abdominal exercises Group

Hypopressive abdominal exercises, balance exercises, general mobility and upper limb strengthening exercises

Abdominal hypopresives exercise Group

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women having given birth 8 weeks before starting the study treatment
  • Women agree to participate in the study
  • Women with vaginal delivery.

You may not qualify if:

  • Women with abdominal hernia
  • Pregnancy woman
  • Previus Abdominal Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iria Da Cuña Carrera

Pontevedra, 36005, Spain

Location

Related Publications (6)

  • Da Cuna-Carrera I, Alonso-Calvete A, Soto-Gonzalez M, Lantaron-Caeiro EM. How Do the Abdominal Muscles Change during Hypopressive Exercise? Medicina (Kaunas). 2021 Jul 9;57(7):702. doi: 10.3390/medicina57070702.

    PMID: 34356983BACKGROUND
  • Carrera Perez C, Da Cuna Carrera I, Gonzalez Gonzalez Y. [What is the best exercise for rehabilitation of abdominal diastasis rehabilitation?]. Rehabilitacion (Madr). 2019 Jul-Sep;53(3):198-210. doi: 10.1016/j.rh.2018.12.004. Epub 2019 Apr 11. Spanish.

    PMID: 31370947BACKGROUND
  • Da Cuna-Carrera I, Alonso-Calvete A, Lantaron-Caeiro EM, Soto-Gonzalez M. Are There Any Differences in Abdominal Activation between Women and Men during Hypopressive Exercises? Int J Environ Res Public Health. 2021 Jun 29;18(13):6984. doi: 10.3390/ijerph18136984.

    PMID: 34210004BACKGROUND
  • 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
  • Lee D, Hodges PW. Behavior of the Linea Alba During a Curl-up Task in Diastasis Rectus Abdominis: An Observational Study. J Orthop Sports Phys Ther. 2016 Jul;46(7):580-9. doi: 10.2519/jospt.2016.6536.

    PMID: 27363572BACKGROUND
  • Soto-Gonzalez M, Da Cuna-Carrera I, Lantaron-Caeiro EM, Pascoal AG. Effect of hypopressive and conventional abdominal exercises on postpartum diastasis recti: A randomized controlled trial. PLoS One. 2024 Dec 12;19(12):e0314274. doi: 10.1371/journal.pone.0314274. eCollection 2024.

Study Officials

  • Iria Da Cuña-carrera, PHD

    Universitu of Vigo

    PRINCIPAL INVESTIGATOR

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

June 17, 2022

First Posted

June 30, 2022

Study Start

July 1, 2022

Primary Completion

October 10, 2022

Study Completion

December 3, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations