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 April 23, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The goals of this study are to:
* assess the impact of a targeted physical exercise program on activity levels prior to ventral hernia repair in elderly, frail patients using wearable activity monitoring.
* correlate physical activity and the impact of physical exercise with postoperative outcomes, including quality of life, postoperative complications, length of hospital stay, discharge to home, and return to baseline activity.
The investigators intend to randomize one group of elderly, frail patients to perform an exercise program for 6-8 weeks prior to surgery and another group of elde...
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
Trial Officials
Jeremy Warren, MD
Principal Investigator
Prisma Health
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported