Ventral HerniaABVENTURE-PNCT05142618
Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
A study testing Supervised Physical Therapy and Post-operative Precautions in people with Ventral Hernia and Hernia, run by Ohio State University at 1 site in United States.
Trial summary
This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Hernia, Herniorrhaphy
- What is being tested?
- Supervised Physical Therapy and Post-operative Precautions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18+
- Diagnosis of ventral hernia
- Scheduled for elective ventral hernia repair
- Independent functional status
- Transverse hernia width of 2cm or greater
Who cannot join
- Previously diagnosed movement or balance disorder
- Use of ambulatory assistive device (walker or cane)
- Not currently undergoing or planning to undergo physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will perform assessments of several activities of daily living and complete several surveys detailing their pre-surgical abilities, quality of life, and pain. Immediately after their surgical procedure, patients will be randomized in a single-blind manner (investigator) in a 1:1 ratio to supervised physical therapy (8 weeks, twice weekly) or standard post-surgical precautions. Assessments and surveys will be repeated by the blinded investigator at 30 days, 10 weeks, 6 months, and 1 year after surgery.
- Conditions
- Ventral Hernia, Hernia, Herniorrhaphy, Abdominal Wall, Postoperative Period, Physical Therapy Modalities
- Being tested
- Supervised Physical Therapy, Post-operative Precautions
- Keywords
- ventral hernia repair, abdominal core health, physical therapy
- Medical subject headings
- Hernia, Ventral, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Physical TherapyOther
The twice-per-week 8-week course of supervised physical therapy begins 2 weeks after surgery. It targets abdominal core function through progressive muscle retraining and strengthening, and patient-specific posture and body mechanics education.
Post-operative PrecautionsOther
This intervention includes standard of care post-operative instructions typically given to patients undergoing ventral hernia repair across the world. These include limiting strenuous physical activity and a lifting restriction of no more than 10 pounds for 6 weeks. Binder use is also encouraged for 4-6 weeks after the operation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Post-operative Instructions | Active comparator | Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. Receives: Other: Post-operative Precautions |
| Supervised Physical Therapy | Experimental | Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. Receives: Other: Supervised Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Five Times Sit-to-stand Time
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
Measured: Baseline before surgery, 10 weeks after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
Measured: Baseline before surgery, 10 weeks after surgery
Change From Baseline in Quiet Unstable Sitting Test
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
Measured: Baseline before surgery, 10 weeks after surgery
Secondary outcomes (12)
Change in Hernia Related Quality of Life Survey From Baseline
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
Measured: baseline before surgery, 10 weeks after surgery
Change in Timed Up-And-Go Time From Baseline
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
Measured: baseline before surgery, 10 weeks after surgery
Change From Baseline in International Physical Activity Questionnaire - Short Form
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
Measured: baseline before surgery, 10 weeks after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
Measured: baseline before surgery, 10 weeks after surgery
Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory
Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge. A recurrence is determined by if the patient reports thinking the hernia has come back, feeling or seeing a bulge, or having pain or symptoms at the site. A positive response to any of these 3 questions is considered a recurrence. A recurrence is considered a suboptimal outcome.
Measured: 1 year after surgery
Change in Hernia Related Quality of Life Survey From Baseline
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
Measured: baseline before surgery, 1 year after surgery
Change in Timed Up-And-Go Time From Baseline
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
Measured: baseline before surgery, 1 year after surgery
Change From Baseline in International Physical Activity Questionnaire - Long Form
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
Measured: baseline before surgery, 1 year after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
Measured: baseline before surgery, 1 year after surgery
Change From Baseline in Five Times Sit-to-stand Time
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
Measured: baseline before surgery, 1 year after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
Measured: baseline before surgery, 1 year after surgery
Change From Baseline in Quiet Unstable Sitting Test
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
Measured: baseline before surgery, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start19 Apr 2022
- Primary completion18 Feb 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajit Chaudhari, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142618
- Sponsor's protocol ID
- 2021H0336
- Other IDs
- R01DK131207
- Acronym
- ABVENTURE-P
- Status last verified
- May 2026
- First submitted
- 3 Nov 2021
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT05142618
- Acronym / sponsor ID
- ABVENTURE-P / 2021H0336
- Conditions
- Ventral Hernia, Hernia, Herniorrhaphy, Abdominal Wall, Postoperative Period, Physical Therapy Modalities
- Keywords
- ventral hernia repair, abdominal core health, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will perform assessments of several activities of daily living and complete several surveys detailing their pre-surgical abilities, quality of life, and pain. Immediately after their surgical procedure, patients will be randomized in a single-blind manner (investigator) in a 1:1 ratio to supervised physical therapy (8 weeks, twice weekly) or standard post-surgical precautions. Assessments and surveys will be repeated by the blinded investigator at 30 days, 10 weeks, 6 months, and 1 year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Post-operative Instructions | Active comparator | Other: Post-operative PrecautionsParticipants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions. |
| Supervised Physical Therapy | Experimental | Other: Supervised Physical TherapyParticipants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18+
- Diagnosis of ventral hernia
- Scheduled for elective ventral hernia repair
- Independent functional status
- Transverse hernia width of 2cm or greater
Key exclusion criteria (3 listed)
- Previously diagnosed movement or balance disorder
- Use of ambulatory assistive device (walker or cane)
- Not currently undergoing or planning to undergo physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional
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 |
|---|---|---|
| Supervised Physical TherapyThe twice-per-week 8-week course of supervised physical therapy begins 2 weeks after surgery. It targets abdominal core function through progressive muscle retraining and strengthening, and patient-specific posture and body mechanics education. | Other | Supervised Physical Therapy |
| Post-operative PrecautionsThis intervention includes standard of care post-operative instructions typically given to patients undergoing ventral hernia repair across the world. These include limiting strenuous physical activity and a lifting restriction of no more than 10 pounds for 6 weeks. Binder use is also encouraged for 4-6 weeks after the operation. | Other | Standard Post-operative Instructions |
Primary outcome
Change From Baseline in Five Times Sit-to-stand Time
Time frame: Baseline before surgery, 10 weeks after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Time frame: Baseline before surgery, 10 weeks after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
Change From Baseline in Quiet Unstable Sitting Test
Time frame: Baseline before surgery, 10 weeks after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
12 secondary outcomes
Change in Hernia Related Quality of Life Survey From Baseline
Time frame: baseline before surgery, 10 weeks after surgery
Change in Timed Up-And-Go Time From Baseline
Time frame: baseline before surgery, 10 weeks after surgery
Change From Baseline in International Physical Activity Questionnaire - Short Form
Time frame: baseline before surgery, 10 weeks after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Time frame: baseline before surgery, 10 weeks after surgery
Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory
Time frame: 1 year after surgery
Change in Hernia Related Quality of Life Survey From Baseline
Time frame: baseline before surgery, 1 year after surgery
Change in Timed Up-And-Go Time From Baseline
Time frame: baseline before surgery, 1 year after surgery
Change From Baseline in International Physical Activity Questionnaire - Long Form
Time frame: baseline before surgery, 1 year after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Time frame: baseline before surgery, 1 year after surgery
Change From Baseline in Five Times Sit-to-stand Time
Time frame: baseline before surgery, 1 year after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Time frame: baseline before surgery, 1 year after surgery
Change From Baseline in Quiet Unstable Sitting Test
Time frame: baseline before surgery, 1 year after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only de-identified data will be shared with other researchers.
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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 Supervised Physical Therapy and Post-operative Precautions in people with Ventral Hernia and Hernia, run by Ohio State University at 1 site in United States.
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 5 inclusion and 3 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 3 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Five Times Sit-to-stand Time (time frame: Baseline before surgery, 10 weeks after surgery). The study lists 3 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 3 Jun 2026.