Ventral Hernia RepairNCT07642219
Effect of Pressure Biofeedback Training After Ventral Hernioplasty
A study testing pressure biofeedback training and conventional physical therapy program in people with Ventral Hernia Repair, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the effect of pressure biofeedback training on abdominal muscle strength and quality of life in adults following ventral hernioplasty. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Ventral Hernia Repair
- What is being tested?
- pressure biofeedback training and conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2025to 30 Apr 2026
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both males and females
- Their ages ranged 35 to 50
- Their BMI ranged from 18.5 to 27
- All patients were suffering from muscles weakness post-ventral hernioplasty
- All patients began the treatment program 8 weeks post-ventral hernioplasty
- All patients received the same postoperative physical therapy program
- Informed consent was obtained from every patient enrolled in the trial.
Who cannot join
- Pregnancy
- Postpartum less than 6 months.
- Peritonitis
- Bruising or swelling of the abdominal wall.
- Infection
- Musculoskeletal impairments that may hinder the treatment process.
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- Orthopedic impairment that may hinder the treatment process.
- Lumbar surgery in the past year.
- Spinal stenosis.
- Neurological disease.
- Trauma to the lumbar spine.
- Nerve root entrapment.
- Cancer.
- Pre-existing impairment of cardiac function.
- Bone metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF PRESSURE BIOFEEDBACK ON ABDOMINAL MUSCLES STRENGTH AND QUALITY OF LIFE POST VENTRAL HERNIOPLASTY
The goal of this clinical trial is to evaluate the effect of pressure biofeedback training on abdominal muscle strength and quality of life in adults following ventral hernioplasty. The main questions it aims to answer are:
- Is there a significant effect of pressure biofeedback training on abdominal muscle strength in patients following ventral hernioplasty?
- Is there a significant effect of pressure biofeedback training on quality of life in patients following ventral hernioplasty?
Read more
Researchers will compare the effect of adding pressure biofeedback training to a conventional physical therapy program versus a conventional physical therapy program alone to determine whether pressure biofeedback training provides additional benefits in improving abdominal muscle strength and quality of life following ventral hernioplasty.
Participants in the study group will receive pressure biofeedback training in addition to the conventional physical therapy program, while participants in the control group will receive the conventional physical therapy program only.
- Conditions
- Ventral Hernia Repair
- Being tested
- pressure biofeedback training, conventional physical therapy program
- Keywords
- pressure biofeedback, quality of life, abdominal muscles strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure biofeedback trainingOther
participants in study group will receive 30 mins and 3 sessions per week for 8 weeks
conventional physical therapy programOther
A conventional physical therapy program will include abdominal muscle strengthening without pressure biofeedback device.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Other: pressure biofeedback training; Other: conventional physical therapy program |
| control group | Active comparator | Not described Receives: Other: conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
abdominal muscle strength
- Abdominal muscle strength assessment was performed using a pressure biofeedback unit (PBU) to evaluate the activation of the transversus abdominis (TrA) muscle.
- Participants were positioned in a prone lying position on a firm surface, with their arms relaxed by their sides.
- The PBU was placed under the abdomen such that the navel is centered on the device, and the distal edge is aligned with the right and left anterior superior iliac spines.
- The cuff was inflated to 70 mmHg and allowed to stabilize. Normal breathing fluctuations (approximately ±2 mmHg) will be noted, after which participants will be instructed to perform the abdominal draw-in maneuver.
- A pressure reduction of 6-10 mmHg is expected.
- A reduction in pressure held for a minimum of 10 seconds is considered a successful activation of the TrA.
- The procedure was repeated three times, and the average reduction of the three readings was used for analysis; higher scores indicate better abdominal muscle strength.
Measured: Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.
Health-Related Quality of Life
The Arabic version of the 12-Item Short Form Health Survey (SF-12) was used to assess health-related quality of life (HRQoL) before and after the intervention. The SF-12 consists of 12 items covering eight health domains: General Health, Physical Functioning, Role Physical, Bodily Pain, Mental Health, Social Functioning, Role Emotional, and Vitality. Responses were scored using the standard SF-12 scoring algorithm, which applies specific weights to each item according to its contribution to physical and mental health. Weighted scores were combined to generate the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12). Both scores are standardized on a 0-100 scale, with higher scores indicating better HRQoL. Changes in pre- and post-intervention scores were used to evaluate the intervention effect.
Measured: Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start6 Oct 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Hernia RepairStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Ayman Abdellatiff, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642219
- Sponsor's protocol ID
- P.T.REC/012/006111
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF PRESSURE BIOFEEDBACK ON ABDOMINAL MUSCLES STRENGTH AND QUALITY OF LIFE POST VENTRAL HERNIOPLASTY
- ClinicalTrials.gov ID
- NCT07642219
- Acronym / sponsor ID
- P.T.REC/012/006111
- Conditions
- Ventral Hernia Repair
- Keywords
- pressure biofeedback, quality of life, abdominal muscles strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 11 Jun 2026 (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 goal of this clinical trial is to evaluate the effect of pressure biofeedback training on abdominal muscle strength and quality of life in adults following ventral hernioplasty. The main questions it aims to answer are:
- Is there a significant effect of pressure biofeedback training on abdominal muscle strength in patients following ventral hernioplasty?
- Is there a significant effect of pressure biofeedback training on quality of life in patients following ventral hernioplasty?
Researchers will compare the effect of adding pressure biofeedback training to a conventional physical therapy program versus a conventional physical therapy program alone to determine whether pressure biofeedback training provides additional benefits in improving abdominal muscle strength and quality of life following ventral hernioplasty.
Participants in the study group will receive pressure biofeedback training in addition to the conventional physical therapy program, while participants in the control group will receive the conventional physical therapy program only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: pressure biofeedback training, Other: conventional physical therapy program |
| control group | Active comparator | Other: conventional physical therapy program |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both males and females
- Their ages ranged 35 to 50
- Their BMI ranged from 18.5 to 27
- All patients were suffering from muscles weakness post-ventral hernioplasty
- All patients began the treatment program 8 weeks post-ventral hernioplasty
Key exclusion criteria (15 listed)
- Pregnancy
- Postpartum less than 6 months.
- Peritonitis
- Bruising or swelling of the abdominal wall.
- Infection
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 |
|---|---|---|
| pressure biofeedback trainingparticipants in study group will receive 30 mins and 3 sessions per week for 8 weeks | Other | study group |
| conventional physical therapy programA conventional physical therapy program will include abdominal muscle strengthening without pressure biofeedback device. | Other | control group, study group |
Primary outcome
abdominal muscle strength
Time frame: Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.
* Abdominal muscle strength assessment was performed using a pressure biofeedback unit (PBU) to evaluate the activation of the transversus abdominis (TrA) muscle. * Participants were positioned in a prone lying position on a firm surface, with their arms relaxed by their sides. * The PBU was placed under the abdomen such that the navel is centered on the device, and the distal edge is aligned with the right and left anterior superior iliac spines. * The cuff was inflated to 70 mmHg and allowed to stabilize. Normal breathing fluctuations (approximately ±2 mmHg) will be noted, after which participants will be instructed to perform the abdominal draw-in maneuver. * A pressure reduction of 6-10 mmHg is expected. * A reduction in pressure held for a minimum of 10 seconds is considered a successful activation of the TrA. * The procedure was repeated three times, and the average reduction of the three readings was used for analysis; higher scores indicate better abdominal muscle strength.
Health-Related Quality of Life
Time frame: Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.
The Arabic version of the 12-Item Short Form Health Survey (SF-12) was used to assess health-related quality of life (HRQoL) before and after the intervention. The SF-12 consists of 12 items covering eight health domains: General Health, Physical Functioning, Role Physical, Bodily Pain, Mental Health, Social Functioning, Role Emotional, and Vitality. Responses were scored using the standard SF-12 scoring algorithm, which applies specific weights to each item according to its contribution to physical and mental health. Weighted scores were combined to generate the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12). Both scores are standardized on a 0-100 scale, with higher scores indicating better HRQoL. Changes in pre- and post-intervention scores were used to evaluate the intervention effect.
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 11 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pressure biofeedback training and conventional physical therapy program in people with Ventral Hernia Repair, 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 7 inclusion and 15 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 11 Jun 2026. 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?
abdominal muscle strength (time frame: Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.). The study lists 2 primary outcomes in all. 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 11 Jun 2026.