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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05559190
Other study ID # P.T.REC/012/002965
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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