NCT04238156

Brief Summary

The prevalence of abdominal diastasis is high in postpartum. The abdominal diastasis can impair the body posture, the of lumbo-pelvic stability and movement, or breathing. Exercises focused on the transversus abdominis muscle have been proposed as a therapeutic approach for abdominal diastasis. Hypopressive abdominal exercises have been used for postpartum recovery, for specific pathologies related to pregnancy (low back pain, pelvic floor dysfunction ...) and even for the rehabilitation of spinal pathologies. However, there is a lack of studies that determine its effectiveness and clinical utility. The aim of the study will be to analyze the effects of Hypopressive abdominal exercises on postpartum abdominal diastasis, the tone of the transverse abdominal muscle and the pelvic floor musculature. A case series design will be applied, with weekly assessment of the outcomes after the intervention and two months after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

January 15, 2020

Last Update Submit

July 20, 2020

Conditions

Keywords

PostpartumHypopressive abdominal exercisesPelvic floor muscles

Outcome Measures

Primary Outcomes (4)

  • Abdominal Diastasis - Baseline

    Supraumbilical distance between the rectus abdominis * Assessment tool: caliper (electronic, calibrated, precision: 1 mm) * Subject position: supine * Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical

    Pre-intervention

  • Abdominal Diastasis - post-intervention 1

    Supraumbilical distance between the rectus abdominis * Assessment tool: caliper (electronic, calibrated, precision: 1 mm) * Subject position: supine * Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical

    Immediately after the intervention

  • Abdominal Diastasis - post-intervention 2

    Supraumbilical distance between the rectus abdominis * Assessment tool: caliper (electronic, calibrated, precision: 1 mm) * Subject position: supine * Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical

    One month after the intervention

  • Abdominal Diastasis - post-intervention 3

    Supraumbilical distance between the rectus abdominis * Assessment tool: caliper (electronic, calibrated, precision: 1 mm) * Subject position: supine * Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical

    Two months after the intervention

Secondary Outcomes (16)

  • Abdominal tonometry - Baseline

    Pre-intervention

  • Perineal tonometry - Baseline

    Pre-intervention

  • Waist circumference - Baseline

    Pre-intervention

  • Chest circumference - Baseline

    Pre-intervention

  • Abdominal tonometry - post-intervention 1

    Immediately after the intervention

  • +11 more secondary outcomes

Study Arms (1)

Hypopressive abdominal exercises

EXPERIMENTAL

Hypopressive abdominal exercises will be performed in basic postures (standing, sitting and supine position). In each posture, three slow cost-diaphragmatic respiration will be performed followed by an expiratory apnea and a rib cage opening, during 2 to 10 seconds, and an exhalation of 10 to 30 seconds. Each exercise will be repeated three times. There will be 3 stages of application throughout the 12 intervention sessions, supervised by a physical therapist: First stage: To explain the concept of hypopressive respiration and how to perform it. Second stage: To explain and apply the hypopressive abdominal exercises: 1. Axial auto-elongation (reducing curvatures in the sagittal plane); 2. Cervical auto-elongation (chin toward the neck); 3. Moving forward of gravity axis; 4. Activation of the shoulder girdle (shoulder joint decoaptation); 5. Slight knee flexion; 6. Dorsal ankle flexion. Third stage: To review and update all the exercises, increasing their intensity.

Other: Hypopressive abdominal exercises

Interventions

Three sessions per week during four consecutive weeks (Total: 12 sessions). Each session time: 30 minutes.

Hypopressive abdominal exercises

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primiparous or multiparous
  • abdominal diastasis previously diagnosed
  • commitment to perform, at least, 80% of the exercises
  • signed informed consent

You may not qualify if:

  • BMI \> 40 Kg/m2
  • pelvic floor disorders before childbirth
  • drugs with effects on continence or functional properties of the pelvic floor muscles
  • treatment for abdominal diastasis in the last 6 months
  • systemic disease that impairs pelvic floor physiology and urination
  • menopause
  • contraindications to the practice of physical exercise and physical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Córdoba

Córdoba, 14004, Spain

Location

Study Officials

  • Daiana Priscila Rodrigues-de-Souza, PhD

    Universidad de Córdoba

    STUDY DIRECTOR
  • Miriam Ramírez Jiménez, Phys Ther

    Universidad de Córdoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph D, Associate Professor

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 23, 2020

Study Start

January 20, 2020

Primary Completion

July 20, 2020

Study Completion

July 20, 2020

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations