NCT07001046

Brief Summary

Diastasis recti abdominis, or rectus diastasis, is the separation of the two parts of the rectus abdominis muscle along the midline of the linea alba, without any visible defect in the fascia. Diastasis recti abdominis is most frequent during pregnancy and postpartum especially, after cesarean birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
Last Updated

August 19, 2025

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 27, 2024

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inter-recti Separation

    The distance between the medial borders of the rectus abdominis muscles measured in Centimeters (cm) by the diagnostic Ultrasound.

    Assessment was done pre treatment sessions and immediately after 8 weeks of treatment sessions

Secondary Outcomes (3)

  • Abdominal muscle strength

    Assessment was done pre treatment sessions and immediately after 8 weeks of treatment sessions

  • Girth measurements

    Assessment was done pre treatment sessions and immediately after 8 weeks of treatment sessions

  • Satisfaction level

    Assessment was done immediately after 8 weeks of treatment sessions

Study Arms (2)

Group A

EXPERIMENTAL

20 first-time mothers participated in a mobile app-guided exercise program focusing on abdominal muscles. The app was downloaded during their initial visit to supplement their treatment, which they conducted at home three times a week for eight weeks. They also attended follow-up sessions once a week.

Other: Mobile app-directed exercise program

Group B

EXPERIMENTAL

20 first-time mothers participated in a specific abdominal exercise program that included static abdominal exercises, head lifts with posterior pelvic tilting, and progressive curl-up exercises. The exercises were performed for 30 minutes, three times a week, for eight weeks as part of a home routine, along with a weekly follow-up session.

Other: Traditional Abdominal Exercises

Interventions

The mobile app-guided exercise program initially asks the mother questions to collect information. These questions were about their motivation for exercise, the main exercise goal, and the area of focus in the exercise program

Group A

The traditional abdominal exercises program consisted of simple static abdominal exercises, graduated curl-ups, and corrected abdominal crunches with posterior pelvic tilting

Group B

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study targeted the mothers who have a diastasis recti after cesarean birth
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First-time mothers who delivered by a cesarean birth
  • Post-cesarean women between 25 and 35 years old
  • Women with a Diastasis Recti of at least 1 cm separation above the umbilicus and at least 0.5 cm separation below the umbilicus

You may not qualify if:

  • First-time mothers who delivered by a vaginal birth
  • Multiparous mothers
  • Those who have not a Diastasis Recti
  • Mothers under 25 years old and those above 35 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, South Valley University

Qina, Qena Governorate, 83523, Egypt

Location

MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arms Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Women's Health

Study Record Dates

First Submitted

July 27, 2024

First Posted

June 3, 2025

Study Start

April 1, 2023

Primary Completion

October 1, 2023

Study Completion

March 26, 2024

Last Updated

August 19, 2025

Record last verified: 2024-07

Locations