Hernia, VentralNCT05559190
Effect of a Preoperative Pulsed Electromagnetic Field and Abdominal Exercises on Muscle Strength Post Ventral Hernioplasty
A study testing Pulsed electromagnetic field and Graduated abdominal strengthening exercises in people with Hernia, Ventral, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Pulsed electromagnetic field and Graduated abdominal strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 11 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Pulsed electromagnetic field, Graduated abdominal strengthening exercises
- Keywords
- pulsed electromagnetic field, abdominal exercises, ventral hernia repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic fieldOther
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 exercisesOther
Four specific muscle core exercises were performed
| Study group | Role | What they receive |
|---|---|---|
| Pulsed electromagnetic field and selected graduated abdominal exercises (group A) | Experimental | 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. Receives: Other: Pulsed electromagnetic field; Other: Graduated abdominal strengthening exercises |
| Selected graduated abdominal exercises (group B) | Active comparator | The interventions were done preoperatively, patients performed the selected graduated abdominal strengthening exercises for 30 minutes, three sessions per week for six weeks. Receives: Other: Graduated abdominal strengthening exercises |
| Pulsed electromagnetic field (group C) | Active comparator | 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. Receives: Other: Pulsed electromagnetic field |
| Control group | No intervention | Patients were instructed to presume in normal activities of daily living preoperatively, without any abdominal exercises or PEMFT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in the abdominal muscle torque
measured by biodex isokinetic
Measured: Baseline and six weeks after the intervention preoperatively and after four weeks postoperative as follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Jan 2021
- Primary completion28 Dec 2022
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa MA Elsayeh, PhD, Principal investigator, Lecturer at Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559190
- Sponsor's protocol ID
- P.T.REC/012/002965
- Status last verified
- Feb 2023
- First submitted
- 24 Sep 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Pulsed Electromagnetic Field and Abdominal Exercises on Muscle Strength Post Ventral Hernioplasty
- ClinicalTrials.gov ID
- NCT05559190
- Acronym / sponsor ID
- P.T.REC/012/002965
- Conditions
- Hernia, Ventral
- Keywords
- pulsed electromagnetic field, abdominal exercises, ventral hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic field and selected graduated abdominal exercises (group A) | Experimental | Other: Pulsed electromagnetic field, Other: Graduated abdominal strengthening exercisesThe 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. |
| Selected graduated abdominal exercises (group B) | Active comparator | Other: Graduated abdominal strengthening exercisesThe interventions were done preoperatively, patients performed the selected graduated abdominal strengthening exercises for 30 minutes, three sessions per week for six weeks. |
| Pulsed electromagnetic field (group C) | Active comparator | Other: Pulsed electromagnetic fieldThe 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. |
| Control group | No intervention | –Patients were instructed to presume in normal activities of daily living preoperatively, without any abdominal exercises or PEMFT. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients with a strangulated hernia.
- Bowel obstruction, peritonitis or perforation.
- Urgent surgery indication.
- Less than one-year abdominal surgery.
- Infection (local or systemic).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed electromagnetic fieldPulsed 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 | Pulsed electromagnetic field (group C), Pulsed electromagnetic field and selected graduated abdominal exercises (group A) |
| Graduated abdominal strengthening exercisesFour specific muscle core exercises were performed | Other | Pulsed electromagnetic field and selected graduated abdominal exercises (group A), Selected graduated abdominal exercises (group B) |
Primary outcome
the change in the abdominal muscle torque
Time frame: Baseline and six weeks after the intervention preoperatively and after four weeks postoperative as follow up
measured by biodex isokinetic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa MA Elsayeh, PhD principal investigator
Lecturer at Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic field and Graduated abdominal strengthening exercises in people with Hernia, Ventral, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in the abdominal muscle torque (time frame: Baseline and six weeks after the intervention preoperatively and after four weeks postoperative as follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.