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Completed

NCT Number: NCT05931159

Effects of AHEs on DrA 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.

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Key information

Conditions

Diastasis Recti Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Attock Hospital (Private) Limited

Rawalpindi, Punjab Province, 46220, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal Hypopressive Training

Other

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.

Conventional Physical therapy for DrA

Other

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)

Primary outcomes

  1. Inter Recti Distance

    Time frame: 8th Week

    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.

  2. Lumbopelvic Pain

    Time frame: 8th Week

    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'.

  3. The Oswestry Disability Index

    Time frame: 8th Week

    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.

Secondary outcomes

  1. Body Shape Questionnaire

    Time frame: 8th Week

    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.

  2. Double Leg lowering test

    Time frame: 8th Week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Abdominal Hypopressive Exercises on Diastasis Recti in Postpartum Women

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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