Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair (ABVENTURE-P)

This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.

Study Overview

• Status: Completed
• Conditions: Hernia; Ventral Hernia; Physical Therapy Modalities; Abdominal Wall; Postoperative Period; Herniorrhaphy
• Intervention / Treatment: Other: Post-operative Precautions; Other: Supervised Physical Therapy

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Ages 18+
• Diagnosis of ventral hernia
• Scheduled for elective ventral hernia repair
• Independent functional status
• Transverse hernia width of 2cm or greater

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Post-operative Instructions; Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.	Other: Post-operative Precautions; 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.
Experimental: Supervised Physical Therapy; 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.	Other: Supervised Physical Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline before surgery, 10 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	baseline before surgery, 1 year after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline before surgery, 30 days 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.	baseline before surgery, 30 days 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.	baseline before surgery, 30 days 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.	baseline before surgery, 30 days 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.	baseline before surgery, 30 days 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.	baseline before surgery, 30 days 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.	baseline before surgery, 30 days 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.	baseline before surgery, 6 months 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.	baseline before surgery, 6 months 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.	baseline before surgery, 6 months after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form	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.	baseline before surgery, 6 months 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.	baseline before surgery, 6 months 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.	baseline before surgery, 6 months 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.	baseline before surgery, 6 months after surgery

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): February 18, 2025
• Study Completion (Actual): December 23, 2025

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: physical therapy; ventral hernia repair; abdominal core health
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia; Hernia, Ventral
• Other Study ID Numbers: 2021H0336; R01DK131207 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only de-identified data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No