Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
Enrolling by invitation · Not applicable
Conditions studied: Frailty, Ventral Hernia
In brief
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 physical exercise program preoperatively in a cohort of frail, elderly patients. The investigators hypothesize that physical exercise will improve activity levels in elderly patients with frailty prior to ventral hernia repair. The investigators further hypothesize that increased levels of activity preoperatively will correlate with improved postoperative outcomes.
Key facts
- Study ID
- NCT06874413
- Run by
- Prisma Health-Upstate
- People needed
- 120
- Starts
- 2025-03-19
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-27
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 or inguinal 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
You may not qualify if…
- 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 ≥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
Where it is running
- Prisma Health — Greenville, South Carolina, United States
Full record on ClinicalTrials.gov
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