Enhanced Recovery Program for Surgery Complications

(POWER Trial)

Overseen By Brendan Visser, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Unable to use smartphone

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

Compensation: Varies

Number of Visits: 31

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special program, called POWER, can improve recovery after major abdominal surgery. The program uses a mobile app to coach participants on exercise and a Mediterranean diet in the weeks leading up to surgery. Participants will either join this program or receive standard advice to follow a Mediterranean diet and exercise. It suits those scheduled for major abdominal surgery in more than three weeks who can use a smartphone. As an unphased trial, it provides a unique opportunity to explore innovative recovery methods before surgery.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for surgical patients?

Research has shown that prehabilitation programs, such as the POWER program, are generally safe for individuals preparing for major surgeries. These programs can reduce the risk of post-surgery complications. Specifically, one study found that prehabilitation led to fewer post-surgery issues compared to those who did not participate.

The program includes a motivational interview and a mobile app that encourages exercise and a Mediterranean diet. These activities are safe and manageable for most individuals. While research supports the benefits of prehabilitation, discussing with a doctor how it might suit specific health needs is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Recovery Program for Surgery Complications because it introduces a proactive approach to preparing patients for surgery. Unlike standard recommendations that simply advise patients to follow a Mediterranean diet and exercise, the "Prehab" intervention offers a motivational interview and a mobile-app-based coaching program. This personalized guidance aims to actively engage patients in adopting healthier lifestyles in the crucial weeks before surgery, potentially improving surgical outcomes and recovery times. By focusing on personalized motivation and technology-driven support, this program represents a significant shift from traditional pre-surgery advice.

What evidence suggests that this intervention is effective for improving surgical outcomes?

This trial will compare a prehabilitation program with a control group. Research has shown that preparing for surgery through activities like exercise and following a Mediterranean diet, known as prehabilitation, can lead to better surgical outcomes. For example, one study found that people who underwent prehabilitation before heart surgery experienced fewer complications afterward. Specifically, they faced fewer issues compared to those who did not participate in prehabilitation. While not all studies have found significant differences, increasing evidence suggests that prehabilitation can benefit patients undergoing major surgeries. ^{1 2 3 4 5}

Who Is on the Research Team?

Brendan Visser, MD

Principal Investigator

Stanford University

Cindy Kin, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English or Spanish speakers who are scheduled to have major abdominal surgery in more than three weeks and can use a smartphone. It's not suitable for those unable to interact with mobile technology.

Inclusion Criteria

I had major abdominal surgery more than 3 weeks ago.

Exclusion Criteria

Unable to use smartphone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a motivational interview and a mobile-app based coaching program to encourage exercise and a Mediterranean diet in the 3+ weeks prior to surgery

3+ weeks

1 visit (in-person), ongoing app-based interaction

Surgery and Immediate Recovery

Participants undergo major elective abdominal surgery and immediate post-operative recovery

1 week

Follow-up

Participants are monitored for surgical complications and changes in physical performance post-surgery

90 days

Assessments at 30 and 90 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• POWER

Trial Overview The study tests if a motivational interview along with a mobile-app based program promoting exercise and Mediterranean diet before surgery can improve outcomes. Participants will either receive standard care or this special intervention.

How Is the Trial Designed?

Group I: Prehab Experimental Treatment 1 Intervention

This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.

Group II: Control Arm Active Control 1 Intervention

Recommendations to follow Mediterranean diet and exercise regularly before surgery.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. withpower.com withpower.com/trial/phase-surgery-complications-10-2023-36d03

Prehabilitation for Surgery Preparation · Info for Participants In a review of 9 studies involving 549 patients, no significant differences in post-operative complications were found between prehabilitation and standard care ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144543/

Prehabilitation: Impact on Postoperative Outcomes - PMC The evidence supporting prehabilitation continues to grow, highlighting its potential to improve patient outcomes and reduce health care costs.

3. powerbreathe.com powerbreathe.com/wp-content/uploads/2021/10/prehabilitation-2021.pdf

Pre- admission interventions (prehabilitation) to improve ... Modifi- able factors increase the risk of death and complications after surgery (which affect up to 75% of patients2 and reduce quality of life.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000286

Prehabilitation Strategies: Enhancing Surgical Resilience ... Surgery imposes significant physiological and psychological stress, often leading to complications, delayed recovery, and prolonged hospital stays.

5. withpower.com withpower.com/trial/phase-postoperative-complications-2024-52f66

Prehabilitation for Postoperative Complications (Prehab Trial) Prehabilitation before cardiac surgery significantly reduces the number of postoperative complications, with an odds ratio of 0.41 based on a systematic review ...