Clinical trial NCT06874413: Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
Official title: Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Frailty
Ventral Hernia
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Activity levels
timeFrame: 6-8 weeks preoperatively
Secondary outcomes:
measure: Quality of Life Pre- and Postoperative Assessment
timeFrame: 14-30 days postoperatively
measure: Quality of Life Pre- and Postoperative Outcomes
timeFrame: 14-30 days postoperatively
measure: Postoperative Outcomes - Surgical Complications
timeFrame: 14-30 days postoperatively
measure: Postoperative Outcomes - Length of Stay
timeFrame: 14-30 days postoperatively
measure: Postoperative Outcomes - Discharge Location
timeFrame: 14-30 days postoperatively
measure: Postoperative Outcomes - Return to Baseline
timeFrame: 14-30 days postoperatively
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Prisma Health
name: Jeremy Warren, MD
role: PRINCIPAL_INVESTIGATOR
References: