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

NCT ID: NCT05559190

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-01-11

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.

Conditions

Hernia, Ventral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pulsed electromagnetic field

Intervention Type: OTHER

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

Intervention Type: OTHER

Four specific muscle core exercises were performed

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.

Group Type: ACTIVE_COMPARATOR

Graduated abdominal strengthening exercises

Intervention Type: OTHER

Four specific muscle core exercises were performed

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.

Group Type: ACTIVE_COMPARATOR

Pulsed electromagnetic field

Intervention Type: OTHER

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Graduated abdominal strengthening exercises

Four specific muscle core exercises were performed

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohamed Ahmed Elsayeh

Lecturer of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaimaa MA Elsayeh, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer at Faculty of Physical Therapy, Cairo University

Locations

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002965

Identifier Type: -

Identifier Source: org_study_id