Abdominal core rehabilitation to improve outcomes after ventral hernia repair pilot trial
What is this study about?
Hernias can affect abdominal core health by causing pain and problems with core function. Surgery is often needed to repair hernias. Recovery after surgery often involves a lot of pain and restriction of activity. In this study, we want to test if supervised rehabilitation with a physical therapist helps patients get better faster after hernia surgery and reach a higher level of comfort and ability than with standard precautions. We know this is beneficial after orthopedic surgery, but the benefit after hernia surgery is not known.
What will I have to do if I participate?
Before surgery, you’ll take some surveys and do several functional tests, where we’ll ask you to do some activities of daily living like getting up from a chair and walking.
On the day of surgery, you’ll be randomly selected to be in the Standard Precautions group or the Physical Therapy group.
Regardless of which group you’re assigned, you’ll go to your regular follow-up visits with your physician. In addition, you’ll do the surveys and functional tests again 30 days, 10 weeks, 6 months and one year after surgery. We’ll do our best to schedule these on the same day as your follow-up visits to the clinic, but you may be asked to take an extra trip to The Ohio State University Wexner Medical Center for one or more of these testing visits.
Standard precautions group: You’ll follow the instructions provided at the time of surgery to the best of your ability. You may contact your physician’s clinic if you have any questions at any time at the phone number they have given you or through MyChart.
Physical therapy group: You’ll be contacted by Ohio State Wexner Medical Center scheduling to schedule physical therapy appointments at no charge to you. All costs of physical therapy will be paid for by the research study. Several Ohio State Wexner Medical Center physical therapy clinics will be available so that you can choose the one most convenient for you. The first appointment will be approximately two weeks after your hernia repair, with approximately two visits per week over an 8-week period. At least one visit per week will be in person, but depending on how your rehabilitation is progressing and your availability, other visits may be done as a telehealth visit.
What information will you collect?
For this study specifically, we’ll be collecting the surveys and functional test scores mentioned above. We’ll have access to your electronic health record to collect data on your procedure and any visits to your physician or physical therapist. We’ll also access the surveys and phone interviews that you complete as part of the Abdominal Core Health Quality Collaborative (ACHQC) registry.
Why might I choose to participate?
All participants will be compensated for their time for coming to the 10-week ($25), 6-month ($50) and one-year ($100) testing sessions.
If you’re selected to the physical therapy group, you will receive supervised physical therapy for 8 weeks at no cost to you (no co-pays or co-insurance).
Why might I choose not to participate?
You might not want to participate if you don’t want to be assigned to one treatment group or the other, or you don’t feel you can make it to the physical therapy appointments because of your busy schedule or because the physical therapy clinics are too far away from your home or work.
How can I learn more?
If your physician has notified you that you’re eligible, we’ll contact you to discuss the study in greater detail, answer your questions and enroll you if you decide to participate. You can also email us at abventuretrial@osumc.edu (note the b, not a d!) with questions or concerns at any time.