Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Frailty; Ventral Hernia
• Intervention / Treatment: Other: Standard of Care (SOC); Behavioral: Prehabilitation

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 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

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 ≥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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 - Standard of Care; Patient receives standard of care instructions for preparing for ventral hernia repair surgery and recovery. Postoperative outcomes are measured.	Other: Standard of Care (SOC); Patients will receive standard of care preoperative instructions.
Experimental: Group 2 - Physical Exercise Arm; 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; 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.
No Intervention: Group 3 - Observational Cohort; Patient's physical activity is monitored prior to receiving ventral or inguinal hernia repair surgery and postoperative outcomes are measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity levels	Amount of time spent active measured by data from wearable activity monitors	6-8 weeks preoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	14-30 days postoperatively
Postoperative Outcomes - Surgical Complications	Postoperative complications	14-30 days postoperatively
Postoperative Outcomes - Length of Stay	Number of days staying in the hospital prior to discharge	14-30 days postoperatively
Postoperative Outcomes - Discharge Location	Discharge location	14-30 days postoperatively
Postoperative Outcomes - Return to Baseline	Ability to return to baseline activity	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).	14-30 days postoperatively

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: Jeremy Warren, MD, Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Frailty; Hernia, Ventral; Health Services Administration; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Surgical Procedures, Operative; Quality of Health Care; Quality Indicators, Health Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Exercise; Perioperative Care; Standard of Care; Preoperative Exercise
• Other Study ID Numbers: 2290314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No