NCT05559190

Brief Summary

The aim of this study is to investigate the impact of a preoperative pulsed electromagnetic field and abdominal exercises on muscle strength post ventral hernioplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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

January 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

September 24, 2022

Last Update Submit

February 13, 2023

Conditions

Keywords

pulsed electromagnetic fieldabdominal exercisesventral hernia repair

Outcome Measures

Primary Outcomes (1)

  • the change in the abdominal muscle torque

    measured by biodex isokinetic

    Baseline and six weeks after the intervention preoperatively and after four weeks postoperative as follow up

Study Arms (4)

Pulsed electromagnetic field and selected graduated abdominal exercises (group A)

EXPERIMENTAL

The interventions were done preoperatively, received pulsed electromagnetic therapy (PEMFT) on abdominal muscles,15 Hz frequency, 20 gauss amplitude with a rectangular waveform, for 20 minutes then they performed the selected graduated abdominal strengthening exercises for 30 minutes, three sessions per week for six weeks.

Other: Pulsed electromagnetic fieldOther: Graduated abdominal strengthening exercises

Selected graduated abdominal exercises (group B)

ACTIVE COMPARATOR

The interventions were done preoperatively, patients performed the selected graduated abdominal strengthening exercises for 30 minutes, three sessions per week for six weeks.

Other: Graduated abdominal strengthening exercises

Pulsed electromagnetic field (group C)

ACTIVE COMPARATOR

The interventions were done preoperatively, they received pulsed electromagnetic therapy (PEMFT) on abdominal muscles,15 Hz frequency, 20 gauss amplitude with a rectangular waveform, for 20 minutes only.

Other: Pulsed electromagnetic field

Control group

NO INTERVENTION

Patients were instructed to presume in normal activities of daily living preoperatively, without any abdominal exercises or PEMFT.

Interventions

Pulsed electromagnetic field therapy was applied directly over the abdominal muscle from a supine position after the removal of metals or things that can be affected by a magnetic field will be assured prior to magnetic field application. The treatment parameters were set as 15 Hz frequency, 20 gauss amplitude with a rectangular waveform for 20 minutes.

Pulsed electromagnetic field (group C)Pulsed electromagnetic field and selected graduated abdominal exercises (group A)

Four specific muscle core exercises were performed

Pulsed electromagnetic field and selected graduated abdominal exercises (group A)Selected graduated abdominal exercises (group B)

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being subjects of both genders.
  • Between the age of 25-40 years.
  • Diagnosed with a ventral hernia (Grade II \& III) based on surgeon assessment and desired an elective surgical repair.
  • Able to act in the abdominal training program.

You may not qualify if:

  • Patients with a strangulated hernia.
  • Bowel obstruction, peritonitis or perforation.
  • Urgent surgery indication.
  • Less than one-year abdominal surgery.
  • Infection (local or systemic).
  • Orthopedic problem, or neurological impairment that interfere with patient ability to act in the abdominal training program.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Shaimaa MA Elsayeh, PhD

    Lecturer at Faculty of Physical Therapy, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy

Study Record Dates

First Submitted

September 24, 2022

First Posted

September 29, 2022

Study Start

January 1, 2021

Primary Completion

December 28, 2022

Study Completion

January 11, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations