Effects of AHEs on DrA in Postpartum Women

Effects of Abdominal Hypopressive Exercises on Diastasis Recti in Postpartum Women

This study is aimed to determine the effects of Abdominal Hypopressive exercises on IRD, Lumbopelvic pain, Body Image and abdominal muscle function in postpartum women.

Study Overview

• Status: Completed
• Conditions: Diastasis Recti
• Intervention / Treatment: Other: Abdominal Hypopressive Training; Other: Conventional Physical therapy for DrA

Detailed Description

Postnatal women wish to resume abdominal exercises shortly after delivery to improve trunk function and restore the pre-pregnant state of the body. Diastasis recti is a common occurrence in the postpartum period which is associated with both physical impairments and body image concerns. Despite the high prevalence, treatment options are still being explored to identify the best approach to resolve it. Exercise is a conservative method to reduce IRD and improve the associated symptoms and quality of life of postpartum females. Most of the previous studies have used either digital nylon calipers or digital palpation methods for the outcome assessment of DrA which has important implications. Fewer studies have used the gold standard US diagnosis. Despite various studies being conducted on the effect of exercise on DrA, the results are still nonconclusive with a deficiency of a standardized protocol. Multifaceted and clinically meaningful assessments have been proposed to be investigated by the previous literature.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46220
      • Attock Hospital (Private) Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 12 weeks to 36 weeks postpartum
• Both vaginal delivery and C-section
• Lumbopelvic pain (NPRS >4)
• Diagnosis of DrA by calliper: 3 cm below the umbilicus: >22 mm, at the umbilicus: >20 mm, 3 cm above the umbilicus: >14 mm
• Primiparous females

Exclusion Criteria:

• Any conditions affecting the ability to perform exercise or activity of daily living.
• Previous spinal or abdominal surgery, and neuromuscular diseases.
• Severe DrA >5cm with the herniation or requiring surgical repair.
• LBP associated with disc herniation, spondylolysis, and degenerative changes of the spine

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal Hypopressive Training; The Abdominal hypopressive Exercises along with home plan based on conventional exercises.	Other: Abdominal Hypopressive Training; Week 1 and 2 - Patient education , Hypopressive Maneuvers in Standing, Sitting and Supine 5-7 repetitions x 5 sets, with a 10-second hold each time, rest for 30 seconds between each set, 2 days/week. Week 3 and 4, Hypopressive breathing in with varying arm movements along with Week 1 and 2 protocols. Week 5 to 8 - Hypopressive breathing in kneeling, Four-point kneeling and sitting, and supine positions with varying arm movements 5-7 repetitions x 5 sets, with a 10-second hold each time, rest for 30 seconds between each set, 2 days/week.
Active Comparator: Conventional Physical therapy for DrA; Draw-in maneuver in supine, quarduped, prone lying, bent leg fall outs, curl ups, and front and side planks.	Other: Conventional Physical therapy for DrA; Week 1 to 4, Draw-in maneuver in supine, Quadruped and Prone lying, Bent knee Fallouts and Curl ups. (8 to 12 repetitions x 3 sets, 2 days/week) Week 5 to 8, Front and side planks added to week 1 to 4 exercises. (12 to 20 repetitions x e sets, 2 days/week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter Recti Distance	Changes from baseline Ultrasound imaging (US) is the gold standard for IRD assessment. USI is an accurate and valid method of measuring IRD size and location. Patient will be graded as having an IRD of > 22 mm, 3 cm below the umbilicus OR > 20 mm at the umbilicus OR >14 mm, 3 cm above the umbilicus.	8th Week
Lumbopelvic Pain	Changes from baseline The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Zero usually represents 'no pain at all' whereas the upper limit of 10 represents 'the worst pain ever possible'.	8th Week
The Oswestry Disability Index	Changes from baseline The Oswestry Disability Index (ODI) is a validated, 10-point patient-reported outcome questionnaire. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.	8th Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Shape Questionnaire	Changes from baseline the Body shape questionnaire is a self-reported measurement of body shape concerns designed for women to measure concerns about body image problems. The questionnaire has 34 items scored from 1 to 6 points. The overall total score range is between 34 to 204.	8th Week
Double Leg lowering test	Changes from baseline Double leg lowering test is used to assess abdominal muscles and the ability of muscles to maintain the posterior pelvic tilting position against the load. In this test Both legs are raised to a 90-degree angle (vertically) while keeping the upper body flat on the floor. The score is the angle of the legs in degrees from the floor. Total score ranges from 0 to 90 degrees, where 0 degree corresponds to excellent and 90 degrees is for very poor.	8th Week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sarah Ehsan, PP-DPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Low back pain; Diastasis Recti; Diastasis Recti and weakness of Linea alba
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Diastasis, Muscle
• Other Study ID Numbers: REC/01538 Fatima Iftikhar

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