Prehabilitation in Pancreatic Surgery

NCT03688867 | Completed

• 1 other identifier: CASE4218
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Resection; Preoperative Frailty

Outcome Measures

Primary Outcomes (3)

• Change in grip strength

  Participant's grip strength will be measured before and after intervention with a Jamar Dynamometer as follows: 1. Hold both arms at 90-degree angles with the arms held close to the body 2. Perform isometric contraction for 5 seconds and measure the pressure generated from this 3. Both handgrips will be measured three times each and averaged. The greater of the two averages will be recorded

  4 weeks

• Change in number of chair stands in 30 seconds (chair stand test)

  The change in the number of times the participant can fully stand up from a seated position in 30 seconds will be measured as follows: Participant will 1. Sit in the middle of the chair 2. Place their hands on the opposite shoulder crossed at the wrists 3. Keep their feet flat on the floor 4. Keep their back straight and keep their arms against your chest 5. On "Go," rise to a full standing position and then sit back down again 6. Repeat this for 30 seconds 7. If the participant must use his/her arms to stand, stop the test. A score of "0" will be recorded for the number and score. The number of times the patient comes to a full standing position in 30 seconds will be counted. If the patient is over halfway to a standing position when 30 seconds have elapsed, it will count as a stand. Number of times the patient stands in 30 seconds will be recorded.

  4 weeks

• Change in vitals and distance walked via 6-minute walk test

  The change in the participant's 6-minute walk test metrics (vitals and distance walked) 1. Participant's baseline vitals will be recorded, including pulse oximetry prior to walking 2. Participant will walk as far as possible in 6 minutes at a comfortable pace, but not at a run or jog. 3. If they become short of breath or tired, they may slow down, stop, or rest as necessary. Participant may lean against the wall while resting, but will resume walking as soon as they are able. 4. Participant will walk down to the end of the hall, turn around and walk back. They will repeat this until the six minutes have expired. 5. If the participant is unable to complete the full six-minute walk, then the time and distance walked will be recorded as well as the reason for stopping early. Vitals will be recorded immediately after walking

  4 weeks

Secondary Outcomes (6)

• Number of grip exercises

  4 weeks

• Number of chair sit stands performed

  4 weeks

• Number of steps walked

  4 weeks

• Heart rate

  4 weeks

• Energy expenditure

  4 weeks

Study Arms (1)

At-home prehabilitation regimen

EXPERIMENTAL

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.

Behavioral: Prehabilitation regimen

Interventions

Prehabilitation regimen 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.

At-home prehabilitation regimen

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing pancreatic resection over a six-month enrollment

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Matthew Walsh, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 28, 2018
• Study Start: March 19, 2019
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

US (1)