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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое Standard of Care (SOC)
  Patients will receive standard of care preoperative instructions.

Первичные конечные точки

• Activity levels [Срок оценки: 6-8 weeks preoperatively]

Вторичные конечные точки (7)

• Quality of Life Pre- and Postoperative Assessment [Срок оценки: 14-30 days postoperatively]
• Quality of Life Pre- and Postoperative Outcomes [Срок оценки: 14-30 days postoperatively]
• Quality of Life Pre- and Postoperative Outcomes [Срок оценки: 14-30 days postoperatively]
• Postoperative Outcomes - Surgical Complications [Срок оценки: 14-30 days postoperatively]
• Postoperative Outcomes - Length of Stay [Срок оценки: 14-30 days postoperatively]
• Postoperative Outcomes - Discharge Location [Срок оценки: 14-30 days postoperatively]
• Postoperative Outcomes - Return to Baseline [Срок оценки: 14-30 days postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Prisma Health — Greenville

Идентификаторы

NCT: NCT06874413 · 2290314

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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