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

Hernia, Ventral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559190
• Other study ID #: P.T.REC/012/002965
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 11, 2023

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 11, 2023
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Intervention

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.
• Graduated abdominal strengthening exercises
Four specific muscle core exercises were performed

Locations

Country	Name	City	State
Egypt	Shaimaa Mohamed Ahmed Elsayeh	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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