Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
Launched by PRISMA HEALTH-UPSTATE · Mar 11, 2025
Trial Information
Current as of November 07, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is testing whether a targeted pre-surgery exercise program, plus breathing training, can help older adults who are frail before ventral hernia repair. Researchers want to see if being more physically active before surgery leads to better recovery after surgery—things like quality of life, fewer complications, shorter hospital stays, and returning to normal activities sooner. Participants are randomly assigned to one of three groups: standard preoperative care, a 6–8 week prehabilitation program with exercise and daily breathing exercises, or an observational group where activity is monitored without the exercise program.
If you’re considering participation, you’d likely be 65 or older with a ventral hernia planned for repair with mesh, and you’d need to meet a frailty score criterion and have a smartphone to track activity data. Group 3 allows adults 18 and older in a separate observational arm. Across all groups, you’ll wear devices to monitor activity before surgery, and you’ll complete short surveys about quality of life and recovery about 14–30 days after surgery. The study is being conducted at Prisma Health in Greenville, South Carolina, and is currently enrolling by invitation with an expected completion date around mid-2026. No results are available yet.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Groups 1 \& 2:
- • Age 65 or greater
- • Presence of a ventral hernia with plans for elective hernia repair with mesh
- • Willing to consent to study and randomization, including activity data capture
- • Score of ≥6 and ≤11 on the Edmonton Frail Scale OR 5-item modified Frail Index Score \> 0
- • For patients with cardiac disease, additional referral for cardiac risk assessment may be performed at the discretion of the treating surgeon or anesthesiologist. If deemed appropriate risk, patients may still enroll.
- • Uses a smartphone that is capable of downloading the Health Kit application
- * Group 3:
- • Age 18 or older
- • Presence of a ventral hernia with plans for elective repair with mesh
- • Willing to consent to activity data capture
- • Uses a smartphone that is capable of downloading the Health Kit application
- Exclusion Criteria:
- * Group 1 \&2:
- • Age \<65
- • Unwilling or unable to consent to study or randomization
- • Joint or muscle pain with movement at a level of 5 out of 10 or higher per patient report
- • Score of ≤5 or ≥12 on Edmonton Frail Scale
- • mFI-5 positive for congestive heart failure (newly diagnosed or exacerbated within 30 days)
- • Functional dependence that prevents self-guided physical prehabilitation or other condition medically unsuitable for exercises (as determined by surgeon).
- • BMI \>50
- • Parastomal hernia repair or repair without mesh
- • Plan for concurrent procedure
- Group 3:
- • \<18 y/o
- • Unwilling or unable to consent to study
- • Joint or muscle pain with movement at a level of 5 out of 10 or higher per patient report
- • BMI \>50
- • Parastomal hernia repair or repair without mesh
- • Plan for concurrent procedure
About Prisma Health Upstate
Prisma Health-Upstate is a leading healthcare provider in South Carolina, dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. As a part of Prisma Health, the largest healthcare system in the state, Prisma Health-Upstate leverages a robust network of clinical expertise, state-of-the-art facilities, and a commitment to excellence in patient care. The organization focuses on a diverse range of therapeutic areas, fostering collaborations that enhance the development of new treatments and technologies. With a patient-centered approach, Prisma Health-Upstate aims to contribute to the scientific community while ensuring the highest standards of safety and quality in all clinical research endeavors.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Greenville, South Carolina, United States
Patients applied
Trial Officials
Jeremy Warren, MD
Principal Investigator
Prisma Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported