NCT07253844

Brief Summary

This randomized controlled trial aims to compare the effects of Transverse Abdominis (TrA) activation, Rectus Abdominis (RA) strengthening, and their combined approach on inter-rectus distance (IRD) and core stability in postpartum women diagnosed with diastasis rectus abdominis (DRA). Thirty-three participants will be randomly allocated into three groups and will complete a six-week exercise program at the Pakistan Society for the Rehabilitation of the Disabled (PSRD) Hospital, Lahore. The study will use real-time ultrasound and pressure biofeedback assessment to evaluate changes in IRD and core stability. It is hypothesized that TrA activation and the combined intervention will produce greater improvements compared to RA strengthening alone.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Nov 2025May 2026

First Submitted

Initial submission to the registry

November 19, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 19, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

Diastasis Rectus AbdominusInter rectus distanceRectus abdominus strenghtheing

Outcome Measures

Primary Outcomes (1)

  • Inter-rectus Distance (IRD)

    The Inter-rectus Distance (IRD) is the measurement of the separation between the two rectus abdominis muscles along the linea alba. It is assessed using ultrasound imaging while the participant is in a supine position with knees bent.. A high-frequency (7.5 MHz) linear probe will be placed on the abdomen while the patient lies on their back. Images will be taken at three points above, at, and below the belly button.

    Baseline: Before starting the intervention Post-intervention: At the end of 6 weeks of the exercise program

Secondary Outcomes (1)

  • Core stability

    Baseline (pre-intervention) and 6 weeks (post-intervention)

Study Arms (3)

Group A (Transverse abdominis activation)

EXPERIMENTAL
Other: Transverse Abdominis activation exercises

Group B (Rectus abdominis strengthening)

EXPERIMENTAL
Other: Rectus Abdominis Strengthening exercises

Group C (Transverse abdominis activation +rectus abdominis strengthening)

EXPERIMENTAL
Other: combined protocol of both transverse abdominis activation and rectus abdominis strengthening.

Interventions

Group A (TAA) will perform abdominal drawing-in maneuvers (ADIM) in crook lying, side lying, and quadruped positions. They will be instructed to gently draw the belly button inward toward the spine without moving the pelvis or rib cage, emphasizing breathing coordination and pelvic floor co-activation. In the supervised phase, participants will perform 3 sets of 10 repetitions, with each contraction held for 10-20 seconds, and a rest interval of 3 minutes between sets

Group A (Transverse abdominis activation)

Group B (RAS) will perform exercises in supine lying with knees bent, including partial curl-ups, reverse crunches, pelvic tilts, and leg raises with abdominal bracing. The command will be tighten your abdominals as if bracing for a punch, and lift without straining your neck. Each supervised session will include 3 sets of 10-15 repetitions per exercise, progressing in difficulty using added resistance if tolerated, with a 3-minute rest interval between sets

Group B (Rectus abdominis strengthening)

Group C (TAA+RAS) will perform a hybrid protocol integrating both TrA activation and RA strengthening exercises. Each session will begin with ADIM in crook lying, side lying, and quadruped positions, followed by RA exercises including curl-ups, pelvic tilts, and leg raises. The command will be to activate your deep core with breathing, then strengthen your outer abdominals through controlled movements. Each supervised session will consist of 3 sets of 10 repetitions for TrA exercises (10-20 seconds hold) and 3 sets of 10-15 repetitions for RA exercises, with a rest period of 3 minutes between all sets.

Group C (Transverse abdominis activation +rectus abdominis strengthening)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum women diagnosed with DRA
  • Multigravida
  • Delivered a singleton pregnancy via vaginal breech or instrumental delivery

You may not qualify if:

  • Pregnancy
  • Abdominal and pelvic hernias or severe musculoskeletal conditions
  • Patients with abdominal and pelvic surgery
  • Patients with disc herniation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lahore University of biological and applied sciences

Lahore, Punjab Province, Pakistan

Location

Pakistan Society for Rehabilitation of Differently Abled

Lahore, Punjab Province, Pakistan

Location

Related Publications (5)

  • Benjamin DR, Frawley HC, Shields N, van de Water ATM, Taylor NF. Relationship between diastasis of the rectus abdominis muscle (DRAM) and musculoskeletal dysfunctions, pain and quality of life: a systematic review. Physiotherapy. 2019 Mar;105(1):24-34. doi: 10.1016/j.physio.2018.07.002. Epub 2018 Jul 24.

    PMID: 30217494BACKGROUND
  • Olsson A, Woxnerud K, Kiwanuka O, Sandblom G, Stackelberg O. The TOR concept (training, operation, and rehabilitation) applied to a cohort of postpartum women with training-resistant symptomatic rectus diastasis: evaluation 1 year after surgery. BJS Open. 2023 Jan 6;7(1):zrac162. doi: 10.1093/bjsopen/zrac162.

    PMID: 36734959BACKGROUND
  • Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008.

    PMID: 29351646BACKGROUND
  • Pascoal AG, Dionisio S, Cordeiro F, Mota P. Inter-rectus distance in postpartum women can be reduced by isometric contraction of the abdominal muscles: a preliminary case-control study. Physiotherapy. 2014 Dec;100(4):344-8. doi: 10.1016/j.physio.2013.11.006. Epub 2014 Jan 18.

    PMID: 24559692BACKGROUND
  • Berg-Poppe P, Hauer M, Jones C, Munger M, Wethor C. Use of exercise in the management of postpartum diastasis recti: a systematic review. The Journal of Women's & Pelvic Health Physical Therapy. 2022;46(1):35-47.

    BACKGROUND

Study Officials

  • Muhammad tariq Shafi, BSPT,tDPT

    Lahore University of Biological and Applied Sciences

    STUDY CHAIR

Central Study Contacts

Attia Mehboob, Doctor of Physical Therapy

CONTACT

Muhammad Tariq Shafi, BSPT, t-DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, blinding of participants and therapists was not be feasible. However, to minimize assessment bias, outcome assessors remained blinded to group allocations which establishing a single-blind study design.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

November 25, 2025

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared, including demographic characteristics (age, parity, BMI), baseline and post-intervention ultrasound measurements of inter-rectus distance (IRD), abdominal muscle strength scores, and functional outcome or patient-reported measures related to abdominal function. Data will also include group allocation (Transverse Abdominis Activation or Rectus Abdominis Strengthening) for analysis comparison. All shared data will be stripped of any personal identifiers to ensure participant confidentiality. The shared dataset will be available in a coded format for secondary analysis and research transparency purposes only.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The de-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, and informed consent form) will be made available after completion of data analysis and publication of the main study results, approximately 6 months after study completion. The data will remain accessible for a period of 3 years following the publication date. Requests for data access must be submitted to the principal investigator and will be reviewed to ensure appropriate use consistent with ethical and confidentiality standards. No personally identifiable information will be shared at any stage.
Access Criteria
De-identified individual participant data (IPD) and supporting information (study protocol, analysis plan, and informed consent form) will be available to qualified researchers, academicians, and postgraduate students conducting studies related to abdominal rehabilitation, physiotherapy, or maternal health. Access will be provided upon reasonable written request to the principal investigator, accompanied by a brief research proposal and data use agreement ensuring confidentiality. Approved users will receive the data in an electronic, password-protected format via institutional email. The data will be shared solely for academic and non-commercial research purposes, with strict adherence to ethical and privacy standards.

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