Effects of AHEs on DrA in Postpartum Women

Diastasis Recti Clinical Trial

Official title:

Effects of Abdominal Hypopressive Exercises on Diastasis Recti in Postpartum Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05931159
• Other study ID #: REC/01538 Fatima Iftikhar
• Status: Completed
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 22, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastasis Recti
• Diastasis, Muscle

Intervention

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.
• 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)

Locations

Country	Name	City	State
Pakistan	Attock Hospital (Private) Limited	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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