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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.
The goals of this study are to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Group 3 - Observational Cohort | No Intervention | Patient's physical activity is monitored prior to receiving ventral or inguinal hernia repair surgery and postoperative outcomes are measured. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Activity levels | Amount of time spent active measured by data from wearable activity monitors | 6-8 weeks preoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Pre- and Postoperative Assessment | 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. | 14-30 days postoperatively |
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Inclusion Criteria:
Groups 1 & 2:
Group 3:
Exclusion Criteria:
Group 1 &2:
Group 3:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Warren, MD | Prisma Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health | Greenville | South Carolina | 29615 | United States |
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| Standard of Care (SOC) | Other | Patients will receive standard of care preoperative instructions. |
|
| Quality of Life Pre- and Postoperative Outcomes |
Quality of life as measured by the Patient-Reported Outcome Measurement Information System (PROMIS-3). |
| 14-30 days postoperatively |
| Quality of Life Pre- and Postoperative Outcomes | Quality of life as measured by the Patient-Reported Outcome Measurement Information System (EuraHS). | 14-30 days postoperatively |
| Postoperative Outcomes - Surgical Complications | Postoperative complications | 14-30 days postoperatively |
| Postoperative Outcomes - Length of Stay | Number of days staying in the hospital prior to discharge | 14-30 days postoperatively |
| Postoperative Outcomes - Discharge Location | Discharge location | 14-30 days postoperatively |
| Postoperative Outcomes - Return to Baseline | Ability to return to baseline activity | 14-30 days postoperatively |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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