Prehabilitation for Ventral Hernia

Overseen By Abby M Birrell, BA

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Prisma Health-Upstate

Disqualifiers: Age <65, Joint pain, BMI >50, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if physical exercise can help elderly patients with frailty recover better after ventral hernia surgery. Participants will either follow standard care, engage in a pre-surgery exercise program (prehabilitation), or have their activity monitored. The trial targets individuals 65 or older with a ventral hernia who can use a smartphone and wish to improve their post-surgery outcomes. Participants should not have severe joint or muscle pain, and their body mass index (BMI) should be 50 or lower. As an unphased trial, this study offers participants the opportunity to contribute to understanding how exercise can enhance recovery, potentially benefiting future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation program is safe for elderly patients with frailty?

Research has shown that prehabilitation, involving physical exercises before surgery, is generally safe for patients. One study found that patients who performed these exercises before ventral hernia surgery experienced fewer complications 30 days post-operation. This suggests that the program is safe and may help reduce risks. Another study found that patients who engaged in prehabilitation were more likely to remain free of hernias and other issues over time. These findings support the idea that prehabilitation is a safe method to enhance surgical outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how prehabilitation, including physical exercise and respiratory training, might enhance recovery from ventral hernia surgery, especially in elderly patients with frailty. Unlike standard surgical preparation, which typically involves general instructions for care, this approach uses a structured exercise program through the SilverSneakers Program, combined with daily respiratory training using an incentive spirometer. This method is unique because it leverages physical conditioning and respiratory exercises to potentially improve surgical outcomes and speed up recovery, offering a proactive way to strengthen patients before surgery. By monitoring activity levels with wearable devices, the trial seeks to uncover how preoperative fitness might impact postoperative success, which could revolutionize the way we prepare patients for surgery.

What evidence suggests that prehabilitation might be an effective treatment for ventral hernia?

Research has shown that getting fit before surgery, known as prehabilitation, can be beneficial. In one study, patients who engaged in prehabilitation walked 61 meters more in a 6-minute test, indicating better physical improvement. Another study with nearly 3,000 patients found that those who exercised before surgery experienced better results. While the exact effects on recovery can vary, prehabilitation often enhances physical activity and healing. In this trial, one group of elderly patients with frailty will participate in a specific exercise program before surgery, which could improve outcomes for those undergoing ventral hernia repair. ^{1 6 7 8 9}

Who Is on the Research Team?

Jeremy Warren, MD

Principal Investigator

Prisma Health

Are You a Good Fit for This Trial?

This trial is for elderly, frail patients who need ventral hernia repair surgery. Participants should be physically able to engage in a targeted exercise program before their surgery.

Inclusion Criteria

Group 3: Uses a smartphone that is capable of downloading the Health Kit application

Group 3: Willing to consent to activity data capture

I am somewhat frail according to a specific health scale.

Exclusion Criteria

I cannot do exercises on my own due to my health condition.

I am under 65 years old.

Groups 1 & 2: Score of < 6 or >11 on Edmonton Frail Scale

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a targeted physical exercise program for 6-8 weeks prior to ventral hernia repair, monitored by wearable activity monitors

6-8 weeks

Regular monitoring via wearable devices

Surgery and Immediate Recovery

Participants undergo ventral hernia repair surgery and immediate postoperative recovery

1-2 weeks

Follow-up

Participants are monitored for postoperative outcomes, including quality of life, complications, and return to baseline activity

2-4 weeks

Follow-up assessments at 14-30 days postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation

Trial Overview The study is testing if doing specific physical exercises and breathing muscle training (prehabilitation) before the surgery can help improve recovery compared to the usual care given without special pre-surgery exercises.

How Is the Trial Designed?

Group I: Group 2 - Physical Exercise Arm Experimental Treatment 1 Intervention

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 II: Group 1 - Standard of Care Active Control 1 Intervention

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

Group III: Group 3 - Observational Cohort Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

Published Research Related to This Trial

A systematic review of 33 studies involving 3167 citations found that prehabilitation did not significantly improve postoperative function, quality of life, or pain in patients undergoing knee or hip arthroplasty for osteoarthritis.

However, prehabilitation programs lasting over 500 minutes may reduce the need for postoperative rehabilitation, indicating a potential benefit in healthcare utilization, even though no significant reductions in readmissions or nursing home placements were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. Cabilan, CJ., Hines, S., Munday, J.[2022]

This systematic review aims to evaluate the effectiveness of various prehabilitation interventions, such as physical activity and nutritional support, in improving surgical outcomes for patients undergoing elective surgery, based on randomized controlled trials (RCTs).

The review will follow rigorous guidelines and assess the quality of studies to identify which specific prehabilitation strategies are most effective in reducing postoperative complications and enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-admission interventions to improve outcome after elective surgery-protocol for a systematic review. Perry, R., Scott, LJ., Richards, A., et al.[2021]

Prehabilitation, which includes physical exercise, nutritional, and psychological support before surgery, has been shown to improve cardiopulmonary fitness and reduce postoperative complications, leading to better recovery outcomes.

Current evidence suggests that individualized prehabilitation programs, which can be home-based or supervised in hospitals, are essential for maximizing effectiveness, although more research is needed to determine the optimal structure of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation, improving postoperative outcomes. Chmelo, J., Chmelová, I., Phillips, AW.[2021]

Prehabilitation, which involves physical exercise before surgery, can significantly improve postoperative recovery and reduce complications, especially in elderly patients with poor preoperative functional status.

An effective prehabilitation program typically includes three sessions per week of endurance and muscle reinforcement exercises for six to eight weeks prior to surgery, enhancing overall patient management and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prehabilitation. Preparing patients for surgery to improve functional recovery and reduce postoperative morbidity]. Debes, C., Aissou, M., Beaussier, M.[2014]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40113616/

Effectiveness of prehabilitation for patients undergoing ... Patients showed functional improvement (mean + 61 m in 6MWT), with no significant differences in postoperative outcomes. Conclusion: Prehabilitation positively ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06874413

Targeted Prehabilitation With Physical Exercise and ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0039606021001987#!

Preoperative exercise and outcomes after ventral hernia ... A total of 2,994 patients were included in the study, out of which 1,519 (50.7%) patients reported no preoperative exercise, 662 (22.1%) sporadic exercise, 467 ...

4. journals.plos.org journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0324002

Effect of tailored, intensive prehabilitation for risky lifestyles ... This trial will compare the effect of combined and individually tailored prehabilitation with standard care on postoperative outcomes, health, ...

5. link.springer.com link.springer.com/article/10.1007/s10029-025-03392-x

Obesity-focused prehabilitation strategies in ventral hernia This study evaluated the impact of different preoperative weight loss strategies on ventral hernia repair outcomes as well as postoperative ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30048306/

Modifying Risks in Ventral Hernia Patients With Prehabilitation Prehabilitation patients have a higher likelihood of being hernia-free and complication-free postoperatively. Although further trials and long-term outcomes ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0324002

Effect of tailored, intensive prehabilitation for risky lifestyles ... This trial will compare the effect of combined and individually tailored prehabilitation with standard care on postoperative outcomes, health, and cost- ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33201119/

Two-year Outcomes of Prehabilitation Among Obese Patients ... Primary outcome was percentage of hernia-free and complication-free patients at 2 years. Complications included recurrence, reoperation, and ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039606021001987

Making the case for prehabilitation in ventral hernia patients A preliminary study involving prehabilitation for VHR patients found individuals who participated in prehabilitation had decreased complications at 30-days ...