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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Prehabilitation for ventral hernia?

Research suggests that prehabilitation, which includes nutritional counseling and exercise, can help reduce complications and improve outcomes for patients undergoing ventral hernia repair. This approach has been shown to make patients healthier before surgery, potentially leading to fewer complications and a smoother recovery. ^{1 2 3 4 5}

How does the treatment Prehabilitation differ from other treatments for ventral hernia?

Prehabilitation is unique because it focuses on improving a patient's physical fitness and overall health before surgery through a combination of exercises, nutritional counseling, and sometimes psychological support. This approach aims to reduce surgical risks and enhance recovery, unlike traditional treatments that typically address the condition only during or after surgery. ^{1 2 6 7 8}

Research Team

Jeremy Warren, MD

Principal Investigator

Prisma Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

The European Hernia Society Prehabilitation Project: a systematic review of patient prehabilitation prior to ventral hernia surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Predictors of poor outcomes in functionally dependent patients undergoing ventral hernia repair. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Pre-admission interventions to improve outcome after elective surgery-protocol for a systematic review. [2021]

5. Denmark pubmed.ncbi.nlm.nih.gov

Nationwide analysis of prolonged hospital stay and readmission after elective ventral hernia repair. [2016]

6. Australia pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Prehabilitation. Preparing patients for surgery to improve functional recovery and reduce postoperative morbidity]. [2014]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

Prehabilitation, improving postoperative outcomes. [2021]