NCT05931159

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

June 26, 2023

Last Update Submit

December 26, 2023

Conditions

Diastasis Recti

Keywords

Diastasis RectiDiastasis Recti and weakness of Linea albaLow back pain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Body Shape Questionnaire

    8th Week

  • Double Leg lowering test

    8th Week

Study Arms (2)

Abdominal Hypopressive Training

EXPERIMENTAL

The Abdominal hypopressive Exercises along with home plan based on conventional exercises.

Other: Abdominal Hypopressive Training

Conventional Physical therapy for DrA

ACTIVE COMPARATOR

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

Interventions

Abdominal Hypopressive TrainingOTHER

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.

Abdominal Hypopressive Training
Conventional Physical therapy for DrAOTHER

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)

Conventional Physical therapy for DrA

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attock Hospital (Private) Limited

Rawalpindi, Punjab Province, 46220, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah Ehsan, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

June 13, 2023

Primary Completion

December 1, 2023

Study Completion

December 22, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)