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

NCT06874413 | Enrolling By Invitation

• 1 other identifier: 2290314
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Activity levels

  Amount of time spent active measured by data from wearable activity monitors

  6-8 weeks preoperatively

Secondary Outcomes (6)

• Quality of Life Pre- and Postoperative Assessment

  14-30 days postoperatively

• Quality of Life Pre- and Postoperative Outcomes

  14-30 days postoperatively

• Postoperative Outcomes - Surgical Complications

  14-30 days postoperatively

• Postoperative Outcomes - Length of Stay

  14-30 days postoperatively

• Postoperative Outcomes - Discharge Location

  14-30 days postoperatively

Study Arms (3)

Group 1 - Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care (SOC)

Group 2 - Physical Exercise Arm

EXPERIMENTAL

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

Group 3 - Observational Cohort

NO INTERVENTION

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

Interventions

Prehabilitation 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 2 - Physical Exercise Arm

Standard of Care (SOC) OTHER

Patients will receive standard of care preoperative instructions.

Group 1 - Standard of Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Frailty; Hernia, Ventral

Interventions

Preoperative Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jeremy Warren, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 13, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)