- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04238156
Hypopressive Abdominal Exercise in Postpartum Abdominal Diastasis (HipoDiastasi)
Hypopressive Abdominal Exercise Effectiveness in Postpartum Abdominal Diastasis, Tone of the Transverse Muscle and the Pelvic Floor Muscles - Case Series
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Córdoba, Spain, 14004
- University of Cordoba
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primiparous or multiparous
- abdominal diastasis previously diagnosed
- commitment to perform, at least, 80% of the exercises
- signed informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypopressive abdominal exercises
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. |
Three sessions per week during four consecutive weeks (Total: 12 sessions).
Each session time: 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal Diastasis - Baseline
Time Frame: Pre-intervention
|
Supraumbilical distance between the rectus abdominis
|
Pre-intervention
|
Abdominal Diastasis - post-intervention 1
Time Frame: Immediately after the intervention
|
Supraumbilical distance between the rectus abdominis
|
Immediately after the intervention
|
Abdominal Diastasis - post-intervention 2
Time Frame: One month after the intervention
|
Supraumbilical distance between the rectus abdominis
|
One month after the intervention
|
Abdominal Diastasis - post-intervention 3
Time Frame: Two months after the intervention
|
Supraumbilical distance between the rectus abdominis
|
Two months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal tonometry - Baseline
Time Frame: Pre-intervention
|
Tonometric evaluation on the white line (linea alba) and the abdominal muscles
|
Pre-intervention
|
Perineal tonometry - Baseline
Time Frame: Pre-intervention
|
Tonometric evaluation on the perineal muscles
|
Pre-intervention
|
Waist circumference - Baseline
Time Frame: Pre-intervention
|
Waist circumference
|
Pre-intervention
|
Chest circumference - Baseline
Time Frame: Pre-intervention
|
Chest circumference
|
Pre-intervention
|
Abdominal tonometry - post-intervention 1
Time Frame: Immediately after the intervention
|
Tonometric evaluation on the white line (linea alba) and the abdominal muscles
|
Immediately after the intervention
|
Perineal tonometry - post-intervention 1
Time Frame: Immediately after the intervention
|
Tonometric evaluation on the perineal muscles
|
Immediately after the intervention
|
Waist circumference - post-intervention 1
Time Frame: Immediately after the intervention
|
Waist circumference
|
Immediately after the intervention
|
Chest circumference - post-intervention 1
Time Frame: Immediately after the intervention
|
Chest circumference
|
Immediately after the intervention
|
Abdominal tonometry - post-intervention 2
Time Frame: One month after the intervention
|
Tonometric evaluation on the white line (linea alba) and the abdominal muscles
|
One month after the intervention
|
Perineal tonometry - post-intervention 2
Time Frame: One month after the intervention
|
Tonometric evaluation on the perineal muscles
|
One month after the intervention
|
Waist circumference - post-intervention 2
Time Frame: One month after the intervention
|
Waist circumference
|
One month after the intervention
|
Chest circumference - post-intervention 2
Time Frame: One month after the intervention
|
Chest circumference
|
One month after the intervention
|
Abdominal tonometry - post-intervention 3
Time Frame: Two months after the intervention
|
Tonometric evaluation on the white line (linea alba) and the abdominal muscles
|
Two months after the intervention
|
Perineal tonometry - post-intervention 3
Time Frame: Two months after the intervention
|
Tonometric evaluation on the perineal muscles
|
Two months after the intervention
|
Waist circumference - post-intervention 3
Time Frame: Two months after the intervention
|
Waist circumference
|
Two months after the intervention
|
Chest circumference - post-intervention 3
Time Frame: Two months after the intervention
|
Chest circumference
|
Two months after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Daiana Priscila Rodrigues-de-Souza, PhD, Universidad de Córdoba
- Principal Investigator: Miriam Ramírez Jiménez, Phys Ther, Universidad de Córdoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HipoDiastasis4073-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Abdominal Diastasis
-
Umeå UniversityRecruitingAbdominal Rectus DiastasisSweden
-
InMode MD Ltd.CompletedDiastasis Recti | Abdominal Wall RestorationUnited States
-
Tampere University HospitalCompletedSubcutaneous Abdominal Fat | Abdominal Skin Elasticity | Rectus Muscle Diastasis | Unpleasant Body Contour
-
University of ValenciaRecruitingAbdominal DiastasisSpain
-
University of ZurichTerminatedDiastasis Recti | Interrectal Distance | Dimensions of the Muscles of the Lateral Abdominal WallSwitzerland
-
AZ AlmaCompleted
-
University of Castilla-La ManchaNot yet recruitingDiastasis Recti | Diastasis Recti and Weakness of the Linea Alba | Diastasis Recti Abdominis | Diastasis
-
Foundation University IslamabadActive, not recruitingDiastasis Recti AbdominisPakistan
-
Norwegian School of Sport SciencesThe Norwegian Women´s Public Health AssociationCompletedDiastasis Recti | Diastasis Recti AbdominisNorway
-
Riphah International UniversityRecruiting
Clinical Trials on Hypopressive abdominal exercises
-
University of VigoCompleted
-
Riphah International UniversityCompleted
-
Kafrelsheikh UniversityNot yet recruiting
-
University of AlcalaCompletedPelvic Floor DisordersSpain
-
Rafael J. CurbeloCompletedMild Pelvic Floor Dysfunction
-
University of SevilleCompleted
-
University of ValenciaCompletedPostpartum WomenSpain
-
University of JaenCompletedMuscle Weakness | Postural; Defect | Pelvic Floor DisordersSpain
-
Riphah International UniversityCompletedUrinary IncontinencePakistan
-
University of ValenciaCompleted