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Enrolling by Invitation

NCT Number: NCT06874413

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.

Enrolling by Invitation

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health

Greenville, South Carolina, 29615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard of Care (SOC)

Other

Patients will receive standard of care preoperative instructions.

Primary outcomes

  1. Activity levels

    Time frame: 6-8 weeks preoperatively

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

Secondary outcomes

  1. Quality of Life Pre- and Postoperative Assessment

    Time frame: 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.

  2. Quality of Life Pre- and Postoperative Outcomes

    Time frame: 14-30 days postoperatively

    Quality of life as measured by the Patient-Reported Outcome Measurement Information System (PROMIS-3).

  3. Quality of Life Pre- and Postoperative Outcomes

    Time frame: 14-30 days postoperatively

    Quality of life as measured by the Patient-Reported Outcome Measurement Information System (EuraHS).

  4. Postoperative Outcomes - Surgical Complications

    Time frame: 14-30 days postoperatively

    Postoperative complications

  5. Postoperative Outcomes - Length of Stay

    Time frame: 14-30 days postoperatively

    Number of days staying in the hospital prior to discharge

  6. Postoperative Outcomes - Discharge Location

    Time frame: 14-30 days postoperatively

    Discharge location

  7. Postoperative Outcomes - Return to Baseline

    Time frame: 14-30 days postoperatively

    Ability to return to baseline activity

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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