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

Primary Purpose

Hernia, Ventral

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulsed electromagnetic field
Graduated abdominal strengthening exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Ventral focused on measuring pulsed electromagnetic field, abdominal exercises, ventral hernia repair

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shaimaa Mohamed Ahmed Elsayeh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

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

Selected graduated abdominal exercises (group B)

Pulsed electromagnetic field (group C)

Control group

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

the change in the abdominal muscle torque
measured by biodex isokinetic

Secondary Outcome Measures

Full Information

First Posted
September 24, 2022
Last Updated
February 13, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05559190
Brief Title
Effect of a Preoperative Pulsed Electromagnetic Field and Abdominal Exercises on Muscle Strength Post Ventral Hernioplasty
Official Title
Effect of Preoperative Pulsed Electromagnetic Field and Abdominal Exercises on Muscle Strength Post Ventral Hernioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
January 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral
Keywords
pulsed electromagnetic field, abdominal exercises, ventral hernia repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed electromagnetic field and selected graduated abdominal exercises (group A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Selected graduated abdominal exercises (group B)
Arm Type
Active Comparator
Arm Description
The interventions were done preoperatively, patients performed the selected graduated abdominal strengthening exercises for 30 minutes, three sessions per week for six weeks.
Arm Title
Pulsed electromagnetic field (group C)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients were instructed to presume in normal activities of daily living preoperatively, without any abdominal exercises or PEMFT.
Intervention Type
Other
Intervention Name(s)
Pulsed electromagnetic field
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Graduated abdominal strengthening exercises
Intervention Description
Four specific muscle core exercises were performed
Primary Outcome Measure Information:
Title
the change in the abdominal muscle torque
Description
measured by biodex isokinetic
Time Frame
Baseline and six weeks after the intervention preoperatively and after four weeks postoperative as follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA Elsayeh, PhD
Organizational Affiliation
Lecturer at Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaimaa Mohamed Ahmed Elsayeh
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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