NCT06259240

Brief Summary

The purpose of this study was to compare between the effects of prone plank exercises versus ES for DRA in postpartum women.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

February 6, 2024

Last Update Submit

April 3, 2024

Conditions

Post Partum Women

Outcome Measures

Primary Outcomes (4)

  • Ultrasound Imaging Device

    Changes in Interrectus distance above umbilicus at rest from baseline to four weeks after the beginning of intervention

    Eight weeks after the beginning of the intervention

  • Ultrasound Imaging Device

    Changes in Interrectus distance below umblicus at rest from baseline to four weeks after the beginning of intervention

    Eight weeks after the beginning of the intervention

  • Ultrasound Imaging Device

    Changes in Interrectus distance above umbilicus at contraction from baseline to four weeks after the beginning of intervention

    Eight weeks after the beginning of the intervention

  • Ultrasound Imaging Device

    Changes in Interrectus distance below umbilicus at contractionfrom baseline to four weeks after the beginning of intervention

    Eight weeks after the beginning of the intervention

Secondary Outcomes (1)

  • The measuring tape

    Eight weeks after the beginning of the intervention

Study Arms (2)

Prone Plank Exercises

ACTIVE COMPARATOR

Forty two post partum woman will recieve progressive prone plank exercises, three times a week, for eight weeks, and with a moderate hard intensity.

Other: Prone plank exercises

Electrical Stimulation

SHAM COMPARATOR

Forty two post partum woman will recieve electrical stimulation for the rectus abdominis muscle day after day for 8 weeks. The patient position was relaxed in the crook lying position. The session parameters were 30 minutes/session with a low frequency current (50-100Hz).

Device: Electrical Stimulation

Interventions

Prone plank exercisesOTHER

Patients in this group will recieve prone plank exercises, three times a week, for eight weeks, and with a moderate hard intensity. During the first four weeks, the exercises session began with light walking for five minutes followed by corrected exercises. Firstly, women will perform stable prone plank exercises. Secondly, women will be asked to apply the unilateral position of prone plank. Thirdly, using a 65 cm diameter Swiss ball, women will be asked to assume the prone bridge position. During the last four weeks, women will be asked to repeat the same program noting that the progressive prone plank exercises should be applied in a dosage of 20 repetitions, three sets, holding the contraction for one minute, and taking a break for two minutes.

Prone Plank Exercises
Electrical StimulationDEVICE

Electrical Stimulation

Electrical Stimulation

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • they had DRA 12 weeks to 36 months postpartum, and were referred to physiotherapy by a gynaecologist, multiparous with the IRD measuring greater than two cm. Age ranged between 20-35 years. Body mass index didn't exceed 30 kg/m2.

You may not qualify if:

  • they were in ongoing pregnancy, twin pregnancy, premature birth before gestation week 37, and exceeded more than thirty-six months postpartum.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy labs at kafr El sheikh University

Kafr ash Shaykh, 6850001, Egypt

RECRUITING

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Fayiz Elshamy, Professor

    Kafrelsheikh University

    STUDY DIRECTOR

Central Study Contacts

Doaa Salah, Senior

CONTACT

20 101 503 3456ptdoaasalah@gamil.com

Fayiz Elshamy, Professor

CONTACT

20 109 105 0154ff_elshamy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior at Outpatient Clinics, Faculty of Physical Therapy, Cairo University.

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

March 1, 2023

Primary Completion

April 20, 2024

Study Completion

April 30, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations

EG(1)