Prehabilitation in Pancreatic Surgery

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Preoperative Frailty; Pancreatic Resection

Treatments: Behavioral: Prehabilitation regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT03688867

CASE4218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing pancreatic resection over a six-month enrollment

Exclusion criteria

• unable to sign a consent
• require a translator in order to sign the consent
• Non-pancreatic resection candidates

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

At-home prehabilitation regimen

Experimental group

Description:

1. Grip strength: Squeeze a stress ball in your hand, holding it squeezed for 5 seconds. Perform this at least thirty times with each hand over the course of a day. 2. Lower body strength: Perform at least one hundred chair sit-stands in a day. 3. Endurance: Walking at least 7,500 steps in a day.

Treatment:

Behavioral: Prehabilitation regimen