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

NCT ID: NCT06874413

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2026-06-30

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.

Conditions

Frailty; Ventral Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 - Standard of Care

Patient receives standard of care instructions for preparing for ventral hernia repair surgery and recovery. Postoperative outcomes are measured.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: OTHER

Patients will receive standard of care preoperative instructions.

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

Group Type: EXPERIMENTAL

Prehabilitation

Intervention Type: BEHAVIORAL

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.

Group 3 - Observational Cohort

Patient's physical activity is monitored prior to receiving ventral hernia repair surgery and postoperative outcomes are measured.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of Care (SOC)

Patients will receive standard of care preoperative instructions.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Warren, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health

Locations

Prisma Health

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

2290314

Identifier Type: -

Identifier Source: org_study_id