NCT03688867

Prehabilitation in Pancreatic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to use functional studies to study the effectiveness of prehabilitation prior to surgery. The investigators know that stronger patients have better outcomes after surgery compared to weaker patients. This study will help the study team determine if prehabilitation can make patients stronger prior to surgery. It is hoped by learning more about frailty and prehabilitation strategies may be developed to minimize or prevent complications in the future. Participants are being asked to participate in this study because they are going to have a pancreatic procedure.

Detailed description

This study aims to determine if a prehabilitation program can improve three objective frailty metrics and to describe the level of physical activity of pancreatectomy patients prior to their planned resection. Patients undergoing pancreatectomy will undergo routine preoperative work up: Staging PET/CT Chest/Abdomen/Pelvis, and biochemical work up (CBC, CMP, CA 19-9, prealbumin/albumin). During the initial consultation, the patients' resting vitals (including weight) will be recorded. They will then perform the grip strength, 30s CST, and 6MWT to establish their baseline frailty metrics. Available baseline laboratory values (CBC, CMP including albumin), will also be recorded. Research personnel will then provide them with a fitness tracker, stress ball, and prehabilitation routine to follow at home until the day of surgery. They will also be asked to keep a physical log of their completed physical activities. The patients will then complete the prehabilitation program during the time between the initial consultation and date of surgery, which typically occurs 3-4 weeks after the initial consultation date. On the day of surgery, patients will turn in their physical log and their fitness tracker. Data from the fitness tracker will be downloaded onto a Cleveland Clinic encrypted computer. A set of resting vitals will be recorded (again including weight) and the patients will then be asked to perform the three-frailty metrics (grip strength, 30s CST, and 6MWT). After this, the patients will not require any additional testing.

Conditions

• Pancreatic Resection
• Preoperative Frailty

Interventions

Type	Name	Description
BEHAVIORAL	Prehabilitation regimen	The intervention targets individual behavior, specifically a patient's proclivity to exercise prior to pancreatic resection. The prehabilitation program is tailored to the three most commonly used objective frailty metrics currently available and will be implemented during the initial consultation visit in the surgery outpatient clinic, where patients will undergo baseline testing and then provided with a fitness tracker and stress ball. Additionally, they will be provided with an activity log to keep track of their daily activity. Shown below is the activity log.

Timeline

• Start date: 2019-03-19
• Primary completion: 2021-02-18
• Completion: 2021-02-18
• First posted: 2018-09-28
• Last updated: 2023-01-31

Locations

1 site across 1 country: United States