- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07253844
Effects of Transverse Abdominis Activation and Rectus Abdominis Strengthening on Inter-rectus Distance and Core Stability (TrA RA IRD DRA)
Effects of Transverse Abdominis Activation and Rectus Abdominis Strengthening on Inter-rectus Distance and Core Stability Among Patients With Diastasis Rectus Abdominis
Study Overview
Status
Conditions
Detailed Description
Background and Rationale:
Diastasis Rectus Abdominis (DRA) is a prevalent postpartum musculoskeletal condition characterized by the separation of the rectus abdominis muscles along the linea alba, resulting in impaired trunk stability, abdominal weakness, and postural dysfunction. Despite its high prevalence, DRA remains underdiagnosed and undertreated, particularly in developing countries where structured rehabilitation protocols are lacking. Physiotherapy-based interventions focusing on abdominal muscle retraining and core stability have been shown to improve outcomes; however, the relative effectiveness of Transverse Abdominis (TrA) activation, Rectus Abdominis (RA) strengthening, and their combined approach remains uncertain.
Objectives:
This randomized controlled trial aims to compare the effects of TrA activation, RA strengthening, and their combination on inter-rectus distance (IRD) and core stability among postpartum women with DRA.
Methods:
This three-arm, parallel-group randomized controlled trial will be conducted at the Pakistan Society for the Rehabilitation of the Disabled (PSRD) Hospital, Lahore, Pakistan. A total of 33 postpartum women aged 20-40 years, diagnosed with DRA (6 months to 2 years postpartum), will be recruited using non-probability convenience sampling. Participants will be randomly assigned into three groups (n = 11 per group):
Group A (TAA): Transverse Abdominis Activation exercises
Group B (RAS): Rectus Abdominis Strengthening exercises
Group C (TAA + RAS): Combined TrA activation and RA strengthening protocol
Each participant will undergo a 6-week intervention program, including three supervised sessions per week for 3 weeks, followed by a 3-week home exercise program. Each session will last 30-45 minutes and will be supervised by a licensed physical therapist at PSRD.
Outcome Measures:
Primary Outcome: Change in Inter-Rectus Distance (IRD), measured via real-time ultrasound imaging (7.5 MHz linear probe) at three anatomical sites (4.5 cm above, at, and 4.5 cm below the umbilicus), pre- and post-intervention.
Secondary Outcome: Core stability, assessed using a Pressure Biofeedback Unit (PBU) during the abdominal drawing-in maneuver (ADIM) in crook-lying position. Participants will aim to reduce pressure by 6-10 mmHg from a 40 mmHg baseline and sustain the contraction for 10 seconds; the mean of three trials will be recorded.
Randomization and Blinding:
Participants will be randomized using Randomized Allocation Software (Version 1.0) in a 1:1:1 ratio. Due to the exercise-based nature of the interventions, blinding of participants and therapists is not feasible; however, the outcome assessor will remain blinded to group assignments, ensuring a single-blind design.
Data Analysis:
Statistical analysis will be performed using SPSS version 26. Data will first be tested for normality using the Shapiro-Wilk test. A two-way mixed ANOVA will be applied to assess both within-subject effects (time: pre vs. post) and between-subject effects (group: TAA, RAS, TAA+RAS), as well as the interaction effect (time × group) on IRD and core stability outcomes. Post-hoc pairwise comparisons with Bonferroni correction will identify specific between-group differences. Statistical significance will be set at p < 0.05 with a 95% confidence interval.
Expected Clinical Significance:
It is hypothesized that TrA activation exercises will lead to a greater reduction in IRD and improvement in core stability compared to RA strengthening alone. The combined exercise group (TAA + RAS) is expected to demonstrate the most comprehensive benefits due to synergistic activation of both deep and superficial abdominal muscles. The study outcomes are anticipated to provide evidence-based guidance for physiotherapists in postpartum rehabilitation, contributing to the development of standardized, non-invasive exercise protocols for DRA management and improved quality of life in postpartum women.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Attia Mehboob, Doctor of Physical Therapy
- Phone Number: +923230016002
- Email: attiakhan455@gmail.com
Study Contact Backup
- Name: Muhammad Tariq Shafi, BSPT, t-DPT
- Phone Number: +923454190056
- Email: muhammad.tariq@ubas.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Lahore University of Biological and Applied Sciences
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Contact:
- Muhammad tariq shafi, BSPT,tDPT
- Phone Number: +923454190056
- Email: muhammad.tariq@ubas.edu.pk
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Lahore, Punjab Province, Pakistan
- Pakistan Society for Rehabilitation of Differently Abled
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Contact:
- Dr.Aneela Amjad, M.Phil. Physiology
- Phone Number: +923434380078
- Email: draneelapcrs@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
. Postpartum women diagnosed with DRA
- Multigravida
- Delivered a singleton pregnancy via vaginal breech or instrumental delivery
Exclusion Criteria:
. Pregnancy
- Abdominal and pelvic hernias or severe musculoskeletal conditions
- Patients with abdominal and pelvic surgery
- Patients with disc herniation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Transverse abdominis activation)
|
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
|
|
Experimental: Group B (Rectus abdominis strengthening)
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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
|
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Experimental: Group C (Transverse abdominis activation +rectus abdominis strengthening)
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Other: combined protocol of both transverse abdominis activation and 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inter-rectus Distance (IRD)
Time Frame: Baseline: Before starting the intervention Post-intervention: At the end of 6 weeks of the exercise program
|
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.
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Baseline: Before starting the intervention Post-intervention: At the end of 6 weeks of the exercise program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core stability
Time Frame: Baseline (pre-intervention) and 6 weeks (post-intervention)
|
core stability was assessed using the pressure biofeedback unit (PBU), a reliable and non-invasive tool designed to evaluate the activation and control of deep abdominal muscles, particularly TrA.
The PBU consists of a pressure cuff connected to an analog pressure gauge and provides visual feedback on pressure changes in response to subtle lumbo pelvic movements (57).
For assessment, participants were positioned in a crook lying position, and the cuff was positioned under the lumbar spine (L4-L5 region).
The device was inflated to a baseline pressure of 40 mmHg, and participants will be instructed to perform the abdominal drawing-in maneuver, aiming to reduce the pressure by 6-10 mmHg without moving the pelvis or spine.
They were asked to maintain this contraction for 10 seconds, and the procedure will be repeated three times, with the average score recorded for analysis.
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Baseline (pre-intervention) and 6 weeks (post-intervention)
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Collaborators and Investigators
Investigators
- Study Chair: Muhammad tariq Shafi, BSPT,tDPT, Lahore University of Biological and Applied Sciences
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UBAS/ERB/FoRS/25/025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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