Prehabilitation in Pancreatic Surgery

NCT ID: NCT03688867

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2021-02-18

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

At-home prehabilitation regimen

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.

Group Type: EXPERIMENTAL

Prehabilitation regimen

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE4218

Identifier Type: -

Identifier Source: org_study_id