Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair (ABVENTURE-P)
Primary Purpose
Ventral Hernia, Hernia, Herniorrhaphy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised Physical Therapy
Post-operative Precautions
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring ventral hernia repair, abdominal core health, physical therapy
Eligibility Criteria
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
Sites / Locations
- Ohio State University Wexner Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Post-operative Instructions
Supervised Physical Therapy
Arm Description
Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.
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.
Outcomes
Primary Outcome Measures
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.
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Computer-adaptive patient-reported questionnaire asking questions about physical function.
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.
Secondary Outcome Measures
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.
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.
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.
Change from baseline in Tampa Scale of Kinesiophobia - Short Form
Self-reported questions on how fear affects desire and ability to perform physical activities.
Hernia recurrence inventory
Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge.
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.
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.
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.
Change from baseline in Tampa Scale of Kinesiophobia - Short Form
Self-reported questions on how fear affects desire and ability to perform physical activities.
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.
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Computer-adaptive patient-reported questionnaire asking questions about physical function.
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.
Full Information
NCT ID
NCT05142618
First Posted
November 3, 2021
Last Updated
May 26, 2023
Sponsor
Ohio State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05142618
Brief Title
Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
Acronym
ABVENTURE-P
Official Title
Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Hernia, Herniorrhaphy, Abdominal Wall, Postoperative Period, Physical Therapy Modalities
Keywords
ventral hernia repair, abdominal core health, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Post-operative Instructions
Arm Type
Active Comparator
Arm Description
Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.
Arm Title
Supervised Physical Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised Physical Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Post-operative Precautions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Five times sit-to-stand time
Description
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Time Frame
Baseline before surgery, 10 weeks after surgery
Title
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Description
Computer-adaptive patient-reported questionnaire asking questions about physical function.
Time Frame
Baseline before surgery, 10 weeks after surgery
Title
Change from Baseline in Quiet unstable sitting test
Description
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
Time Frame
Baseline before surgery, 10 weeks after surgery
Secondary Outcome Measure Information:
Title
Change in Hernia related quality of life survey from baseline
Description
Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Time Frame
baseline before surgery, 10 weeks after surgery
Title
Change in Timed Up-And-Go time from baseline
Description
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.
Time Frame
baseline before surgery, 10 weeks after surgery
Title
Change from baseline in International Physical Activity Questionnaire - Short Form
Description
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Time Frame
baseline before surgery, 10 weeks after surgery
Title
Change from baseline in Tampa Scale of Kinesiophobia - Short Form
Description
Self-reported questions on how fear affects desire and ability to perform physical activities.
Time Frame
baseline before surgery, 10 weeks after surgery
Title
Hernia recurrence inventory
Description
Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge.
Time Frame
1 year after surgery
Title
Change in Hernia related quality of life survey from baseline
Description
Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Time Frame
baseline before surgery, 1 year after surgery
Title
Change in Timed Up-And-Go time from baseline
Description
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.
Time Frame
baseline before surgery, 1 year after surgery
Title
Change from baseline in International Physical Activity Questionnaire - Long Form
Description
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Time Frame
baseline before surgery, 1 year after surgery
Title
Change from baseline in Tampa Scale of Kinesiophobia - Short Form
Description
Self-reported questions on how fear affects desire and ability to perform physical activities.
Time Frame
baseline before surgery, 1 year after surgery
Title
Change from Baseline in Five times sit-to-stand time
Description
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Time Frame
baseline before surgery, 1 year after surgery
Title
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Description
Computer-adaptive patient-reported questionnaire asking questions about physical function.
Time Frame
baseline before surgery, 1 year after surgery
Title
Change from Baseline in Quiet unstable sitting test
Description
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
Time Frame
baseline before surgery, 1 year after surgery
Other Pre-specified Outcome Measures:
Title
Change in Hernia related quality of life survey from baseline
Description
Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Time Frame
baseline before surgery, 30 days after surgery
Title
Change in Timed Up-And-Go time from baseline
Description
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.
Time Frame
baseline before surgery, 30 days after surgery
Title
Change from baseline in International Physical Activity Questionnaire - Short Form
Description
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Time Frame
baseline before surgery, 30 days after surgery
Title
Change from baseline in Tampa Scale of Kinesiophobia - Short Form
Description
Self-reported questions on how fear affects desire and ability to perform physical activities.
Time Frame
baseline before surgery, 30 days after surgery
Title
Change from Baseline in Five times sit-to-stand time
Description
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Time Frame
baseline before surgery, 30 days after surgery
Title
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Description
Computer-adaptive patient-reported questionnaire asking questions about physical function.
Time Frame
baseline before surgery, 30 days after surgery
Title
Change from Baseline in Quiet unstable sitting test
Description
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
Time Frame
baseline before surgery, 30 days after surgery
Title
Change in Hernia related quality of life survey from baseline
Description
Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Time Frame
baseline before surgery, 6 months after surgery
Title
Change in Timed Up-And-Go time from baseline
Description
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.
Time Frame
baseline before surgery, 6 months after surgery
Title
Change from baseline in International Physical Activity Questionnaire - Long Form
Description
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Time Frame
baseline before surgery, 6 months after surgery
Title
Change from baseline in Tampa Scale of Kinesiophobia - Short Form
Description
Self-reported questions on how fear affects desire and ability to perform physical activities.
Time Frame
baseline before surgery, 6 months after surgery
Title
Change from Baseline in Five times sit-to-stand time
Description
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Time Frame
baseline before surgery, 6 months after surgery
Title
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Description
Computer-adaptive patient-reported questionnaire asking questions about physical function.
Time Frame
baseline before surgery, 6 months after surgery
Title
Change from Baseline in Quiet unstable sitting test
Description
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
Time Frame
baseline before surgery, 6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Di Stasi, PT, PhD
Phone
614-293-4220
Email
abventuretrial@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ajit Chaudhari, PhD
Phone
614-292-0558
Email
ajit.chaudhari@osumc.edu
Facility Information:
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savannah Renshaw
Email
abventuretrial@osumc.edu
First Name & Middle Initial & Last Name & Degree
Stephanie DiStasi, PhD
Email
abventuretrial@osumc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only de-identified data will be shared with other researchers.
Learn more about this trial
Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
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