Effect of a Preoperative Pulsed Electromagnetic Field and Abdominal Exercises on Muscle Strength Post Ventral Hernioplasty

Effect of Preoperative Pulsed Electromagnetic Field and Abdominal Exercises on Muscle Strength Post Ventral Hernioplasty

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Ventral
• Intervention / Treatment: Other: Pulsed electromagnetic field; Other: Graduated abdominal strengthening exercises

Detailed Description

Sixty patients, 25-40 years old, diagnosed with a ventral hernia and consulted for surgical hernia repair, preoperatively, were randomly assigned either into pulsed electromagnetic therapy and graduated abdominal strengthening exercises group (group A), graduated abdominal strengthening exercises group (group B), pulsed electromagnetic therapy group (group C) or group D who is instructed to presume in normal activities of daily living preoperatively, without any abdominal exercises or PEMF. All treatment interventions were applied at a frequency of three sessions per week for six weeks preoperatively. Abdominal muscle torque was measured by a biodex isokinetic dynamometer preoperatively at baseline and after six weeks of intervention and after four months postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt, 02
      • Shaimaa Mohamed Ahmed Elsayeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pulsed electromagnetic field and selected graduated abdominal exercises (group A); 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 field; 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.; Other: Graduated abdominal strengthening exercises; Four specific muscle core exercises were performed
ACTIVE_COMPARATOR: Selected graduated abdominal exercises (group B); 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; Four specific muscle core exercises were performed
ACTIVE_COMPARATOR: Pulsed electromagnetic field (group C); 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; 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.
NO_INTERVENTION: Control group; Patients were instructed to presume in normal activities of daily living preoperatively, without any abdominal exercises or PEMFT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): December 28, 2022
• Study Completion (ACTUAL): January 11, 2023

Study Registration Dates

• First Submitted: September 24, 2022
• First Submitted That Met QC Criteria: September 24, 2022
• First Posted (ACTUAL): September 29, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: abdominal exercises; ventral hernia repair; pulsed electromagnetic field
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: P.T.REC/012/002965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No