Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

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

Detailed Description
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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.

Official Title
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Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

Conditions
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Ventral Hernia, Hernia, Herniorrhaphy, Abdominal Wall, Postoperative Period, Physical Therapy Modalities

Intervention / Treatment
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* Other: Supervised Physical Therapy
* Other: Post-operative Precautions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. | Baseline before surgery, 10 weeks after surgery | 
| Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | Computer-adaptive patient-reported questionnaire asking questions about physical function. | 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. | 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 | Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health. | 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. | 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. | baseline before surgery, 10 weeks after surgery | 
| Change from baseline in Tampa Scale of Kinesiophobia - Short Form | Self-reported questions on how fear affects desire and ability to perform physical activities. | baseline before surgery, 10 weeks after surgery | 
| Hernia recurrence inventory | Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge. | 1 year after surgery | 
| Change in Hernia related quality of life survey from baseline | Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health. | 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. | 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. | baseline before surgery, 1 year after surgery | 
| Change from baseline in Tampa Scale of Kinesiophobia - Short Form | Self-reported questions on how fear affects desire and ability to perform physical activities. | 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. | baseline before surgery, 1 year after surgery | 
| Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | Computer-adaptive patient-reported questionnaire asking questions about physical function. | 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. | baseline before surgery, 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventral hernia repair, abdominal core health, physical therapy