An interventional study of Prehabilitation and Standard of Care (SOC) in Frailty and Ventral Hernia, sponsored by Prisma Health-Upstate. Enrolling by invitation at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Prisma Health-Upstate · Not applicable, Interventional, and Treatment
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.
The goals of this study are to:
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 elderly, frail patients to receive standard of care preoperative instructions.
The investigators will also collect data from a cohort of patients receiving a ventral or inguinal hernia repair who have a wearable activity monitor that are willing to download an application on their phone and allow us to monitor their activity levels prior to surgery.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 120 is above the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Prisma Health-Upstate is the lead sponsor of 76 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Groups 1 \& 2:
Group 3:
Exclusion Criteria:
Group 1 \&2:
Group 3:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient receives standard of care instructions for preparing for ventral hernia repair surgery and recovery. Postoperative outcomes are measured.
Other: Standard of Care (SOC)
Elderly patients with frailty participate in a 6-8 weeks of physical exercise program through the YMCA's SilverSneakers Program monitored by a wearable activity monitor. Patients will also complete respiratory training by using an incentive spirometer daily. Postoperative outcomes are measured
Behavioral: Prehabilitation
Patient's physical activity is monitored prior to receiving ventral or inguinal hernia repair surgery and postoperative outcomes are measured.
Physical prehabilitation or exercise conducted through the YMCA's Silver Sneaker's program prior to receiving surgery that will be assessed through the use of wearable activity monitors.
Patients will receive standard of care preoperative instructions.
Activity levels
Amount of time spent active measured by data from wearable activity monitors
Time frame: 6-8 weeks preoperatively
Quality of Life Pre- and Postoperative Assessment
Quality of life will be measured with the Hernia-Related Quality of Life Survey (HerQLes). This survey is a 12 question survey that measures how strongly the patient agrees or disagrees (strongly, moderately, and slightly agree or disagree) with the statement.
Time frame: 14-30 days postoperatively
Quality of Life Pre- and Postoperative Outcomes
Quality of life as measured by the Patient-Reported Outcome Measurement Information System (PROMIS-3).
Time frame: 14-30 days postoperatively
Quality of Life Pre- and Postoperative Outcomes
Quality of life as measured by the Patient-Reported Outcome Measurement Information System (EuraHS).
Time frame: 14-30 days postoperatively
Postoperative Outcomes - Surgical Complications
Postoperative complications
Time frame: 14-30 days postoperatively
Postoperative Outcomes - Length of Stay
Number of days staying in the hospital prior to discharge
Time frame: 14-30 days postoperatively
Postoperative Outcomes - Discharge Location
Discharge location
Time frame: 14-30 days postoperatively
Postoperative Outcomes - Return to Baseline
Ability to return to baseline activity
Time frame: 14-30 days postoperatively
Plan to share: No
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Prisma Health-Upstate