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

Not Applicable

• Conditions: Frailty; Ventral Hernia

• Registration Number: NCT06874413
• Lead Sponsor: Prisma Health-Upstate

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 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.

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 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 Timeline

• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-13
• Study Start: 2025-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Activity levels	6-8 weeks preoperatively	Amount of time spent active measured by data from wearable activity monitors

Secondary Outcome Measures

Name	Time	Method
Quality of Life Pre- and Postoperative Assessment	14-30 days postoperatively	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.
Quality of Life Pre- and Postoperative Outcomes	14-30 days postoperatively	Quality of life as measured by the Patient-Reported Outcome Measurement Information System (PROMIS-3).
Postoperative Outcomes - Surgical Complications	14-30 days postoperatively	Postoperative complications
Postoperative Outcomes - Length of Stay	14-30 days postoperatively	Number of days staying in the hospital prior to discharge
Postoperative Outcomes - Discharge Location	14-30 days postoperatively	Discharge location
Postoperative Outcomes - Return to Baseline	14-30 days postoperatively	Ability to return to baseline activity

Trial Locations

Locations (1)

Prisma Health; 🇺🇸 Greenville, South Carolina, United States