Status:
ENROLLING_BY_INVITATION
Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
Lead Sponsor:
Prisma Health-Upstate
Conditions:
Frailty
Ventral Hernia
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the physical fitness of patients undergoing hernia repair and correlate the postoperative outcomes and recovery as well as assess the impact of a targeted physic...
Detailed Description
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 monito...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06874413
Start Date
March 19 2025
End Date
June 30 2026
Last Update
April 9 2025
Active Locations (1)
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1
Prisma Health
Greenville, South Carolina, United States, 29615