NCT07642141

Brief Summary

Diastasis Recti Abdominis (DRA) is the separation of the rectus abdominis muscles along the linea alba, commonly seen after childbirth due to the mechanical and hormonal changes that occur during pregnancy. DRA can negatively affect posture, trunk stability, and breathing patterns, and may result in persistent lumbopelvic pain and weakened core muscles if not properly managed. Although hypopressive exercises and abdominal bracing have individually demonstrated positive effects in reducing inter-recti distance and improving core function, limited research exists regarding their combined effects. This randomized clinical trial aims to evaluate the combined impact of hypopressive exercises and abdominal bracing on inter-recti distance, lumbopelvic pain, and abdominal muscle strength in postpartum women with DRA. The study will include 34 postpartum women recruited from Jinnah Hospital, Lahore, who will be randomly assigned into two groups. Group A will receive both hypopressive exercises and abdominal bracing, while Group B will receive only hypopressive exercises along with standard postpartum physiotherapy. Outcome measures will include pain intensity, lumbopelvic disability, abdominal muscle strength, and inter-recti distance, with data analyzed using SPSS version 25.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress88%
Apr 2025Aug 2026

Study Start

First participant enrolled

April 2, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Lumbopelvic painHypopresive ExerciseAbdominal Bracing

Outcome Measures

Primary Outcomes (4)

  • Numerical Pain Rating Scale (NPRS)

    It is a standardized self-reporting scale consisting of a horizontal line used to estimate the subjective level of pain intensity. It is a 11 point numerical scale, corresponding to the degree of pain. 0= no pain, 1-2-3 = mild pain, 4-5-6 = moderate pain, 7-8-9-10 = severe pain. The patients will be asked to select from that 11 points numerical continuum the number that corresponds to their perceived pain intensity. NPRS is considered a valid and reliable scale for measures of pain intensity. NPRS has shown high test-retest (r=0.96 and 0.95 ) reliability.

    6 weeks

  • Pelvic Girdle Questionnaire (PGQ)

    It is a straightforward tool with 25 items, 20 of which measure activity restrictions (the activity subscale) and 5 of which measure symptoms (the symptom subscale). Every item is worth four points and is graded on a Likert scale with a range of 0 to 3. The PGQ has a maximum possible score of 75, which includes 15 for the symptom subscale and 60 for the activity subscale. Three points are deducted from the maximum possible score for an item that has no response or a response of "not applicable." The final figures are displayed as a percentage, with 0 denoting no disability and 100 denoting severe disability. A worse result is indicated by a higher score. PGQ is considered a valid and reliable scale for measuring disability. PGQ has shown test-retest reliability ( 0.93 (activity), .91 (symptom).

    6 weeks

  • Manual muscle testing (MMT)

    Manual muscle testing (MMT) is a widely used clinical method for assessing muscle strength by applying manual resistance to specific muscles or muscle groups and grading the response on a standardized 0-5 scale. It is considered a valid and reliable tool, particularly effective in detecting moderate to severe muscle weakness. Studies report high inter-rater reliability (ICC = 0.85-0.98) and good intra-rater consistency when performed by trained clinicians, especially for muscle grades 3 and above.

    6 weeks

  • Tape measure and Finger-Width Method

    The finger-width method and tape measure are commonly used clinical tools to assess diastasis recti postpartum. The finger-width method shows good intra-rater reliability (Kappa \> 0.7) but only moderate inter-rater reliability (Kappa ≈ 0.53) and limited validity compared to ultrasound. In contrast, the tape measure method demonstrates excellent intra- and inter-rater reliability (ICC = 0.80-1.00) and strong validity, with high correlation to ultrasound (r = 0.82-0.98). While ultrasound remains the 14 gold standard, the tape measure is a more accurate and reliable clinical alternative than the finger-width method.

    6 weeks

Study Arms (2)

Group A: Hypopressive Exercise and Abdominal Bracing

EXPERIMENTAL

The hypopressive exercise protocol included maintaining spinal elongation, a neutral pelvis, knee flexion, and scapular muscle activation. Participants performed diaphragmatic breathing followed by full expiration and a 10-second apnea with rib cage expansion, causing inward abdominal contraction without inhalation. Exercises were performed in lying, sitting, standing, kneeling, and four-point kneeling positions. Each exercise was repeated three times with 30-second rest intervals. The intervention lasted 6 weeks with 12 sessions. Participants in Group A also used an ITA-Med postnatal abdominal binder made of breathable elastic material. The binder covered the area from the pubis to the lower ribs and was worn during waking hours for 6 weeks, except during sleep and bathing. It was applied while lying down and adjusted for a snug but comfortable fit. Participants were instructed to avoid excessive tightness and monitor the skin for irritation.

Other: Hypopressive exercise and Abdominal Bracing

Group B: Hypopressive Exercise only

ACTIVE COMPARATOR

Each exercise was performed during the expiratory phase and required the contraction of the pelvic floor muscles. Participants were instructed to perform between 1 to 3 sets of 10 repetitions per exercise, holding each contraction for 5 seconds followed by 10 seconds of relaxation. The number of sets and the difficult level were progressively adjusted over time.

Other: Hypopressive Exercise

Interventions

The hypopressive exercise protocol included maintaining spinal elongation, a neutral pelvis, knee flexion, and scapular muscle activation. Participants performed diaphragmatic breathing followed by full expiration and a 10-second apnea with rib cage expansion, causing inward abdominal contraction without inhalation. Exercises were performed in lying, sitting, standing, kneeling, and four-point kneeling positions. Each exercise was repeated three times with 30-second rest intervals. The intervention lasted 6 weeks with 12 sessions. Participants in Group A also used an ITA-Med postnatal abdominal binder made of breathable elastic material. The binder covered the area from the pubis to the lower ribs and was worn during waking hours for 6 weeks, except during sleep and bathing. It was applied while lying down and adjusted for a snug but comfortable fit. Participants were instructed to avoid excessive tightness and monitor the skin for irritation.

Group A: Hypopressive Exercise and Abdominal Bracing

Each exercise was performed during the expiratory phase and required the contraction of the pelvic floor muscles. Participants were instructed to perform between 1 to 3 sets of 10 repetitions per exercise, holding each contraction for 5 seconds followed by 10 seconds of relaxation. The number of sets and the difficult level were progressively adjusted over time. This treatment protocol will be performed over a time period of 6 weeks

Group B: Hypopressive Exercise only

Eligibility Criteria

Age23 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group of 23 to 30 years
  • Inter recti distance \> 2 to 5 cm
  • A women who had undergone a vaginal delivery at least 8 weeks before the first measurement
  • A postpartum female with the presence of diastasis rectus abdominis
  • BMI under or equal to 29kg/m2

You may not qualify if:

  • Pregnant females (29)
  • Subjects who underwent any recent abdominal surgeries
  • Patient diagnosed with a Fibroid uterus
  • Patient diagnosed with abdominal hernia
  • Cesarean section (C-section)
  • Chronic medical conditions such as diabetes, uncontrolled hypertension, cardiovascular disease, or thyroid disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (4)

  • Hsia M, Jones S. Natural resolution of rectus abdominis diastasis. Two single case studies. Aust J Physiother. 2000;46(4):301-307. doi: 10.1016/s0004-9514(14)60291-9.

    PMID: 11676815BACKGROUND
  • Mota P, Gil Pascoal A, Bo K. Diastasis recti abdominis in pregnancy and postpartum period. Risk factors, functional implications and resolution. Current women's health reviews. 2015;11(1):59-67

    BACKGROUND
  • Michalska A, Rokita W, Wolder D, Pogorzelska J, Kaczmarczyk K. Diastasis recti abdominis - a review of treatment methods. Ginekol Pol. 2018;89(2):97-101. doi: 10.5603/GP.a2018.0016.

    PMID: 29512814BACKGROUND
  • Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.

    PMID: 30839304BACKGROUND

Study Officials

  • Muzzammil Akhtar

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD*

CONTACT

Imran Amjad, PHD*

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start

April 2, 2025

Primary Completion (Estimated)

July 2, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations