Prehabilitation in Pancreatic Surgery
Primary Purpose
Pancreatic Resection, Preoperative Frailty
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation regimen
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Resection
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
Sites / Locations
- Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
At-home prehabilitation regimen
Arm Description
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. Lower body strength: Perform at least one hundred chair sit-stands in a day. Endurance: Walking at least 7,500 steps in a day.
Outcomes
Primary Outcome Measures
Change in grip strength
Participant's grip strength will be measured before and after intervention with a Jamar Dynamometer as follows:
Hold both arms at 90-degree angles with the arms held close to the body
Perform isometric contraction for 5 seconds and measure the pressure generated from this
Both handgrips will be measured three times each and averaged. The greater of the two averages will be recorded
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
Sit in the middle of the chair
Place their hands on the opposite shoulder crossed at the wrists
Keep their feet flat on the floor
Keep their back straight and keep their arms against your chest
On "Go," rise to a full standing position and then sit back down again
Repeat this for 30 seconds
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.
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)
Participant's baseline vitals will be recorded, including pulse oximetry prior to walking
Participant will walk as far as possible in 6 minutes at a comfortable pace, but not at a run or jog.
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.
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.
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
Secondary Outcome Measures
Number of grip exercises
Participants will complete and record number of stress ball squeezes (Squeezing stress ball in hand and holding it squeezed for 5 seconds) during the prehabilitation period
Number of times squeezed with right hand and number of times squeezed with left hand will be recorded.
Number of chair sit stands performed
Measures lower body strength: Participants will measure the number of chair sit stands they perform in a day during the prehabilitation period.
Number of steps walked
Participants will track the number of steps they walk per day during the prehabilitation period via the provided fitness activity tracker (Garmin Vivofit 4).
Heart rate
Participants will track their heart rate during the prehabilitation period via the provided fitness activity tracker (Garmin Vivofit 4).
Energy expenditure
Participant's energy expenditure will be tracked via the data from the supplied fitness tracker (Garmin Vivofit 4).
Weight change from the baseline
Participant's weight change from the baseline initial consultation to the day of operation will be recorded.
Full Information
NCT ID
NCT03688867
First Posted
September 4, 2018
Last Updated
January 30, 2023
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03688867
Brief Title
Prehabilitation in Pancreatic Surgery
Official Title
Prehabilitation in Pancreatic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
February 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Resection, Preoperative Frailty
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
At-home prehabilitation regimen
Arm Type
Experimental
Arm Description
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.
Lower body strength: Perform at least one hundred chair sit-stands in a day.
Endurance: Walking at least 7,500 steps in a day.
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation regimen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in grip strength
Description
Participant's grip strength will be measured before and after intervention with a Jamar Dynamometer as follows:
Hold both arms at 90-degree angles with the arms held close to the body
Perform isometric contraction for 5 seconds and measure the pressure generated from this
Both handgrips will be measured three times each and averaged. The greater of the two averages will be recorded
Time Frame
4 weeks
Title
Change in number of chair stands in 30 seconds (chair stand test)
Description
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
Sit in the middle of the chair
Place their hands on the opposite shoulder crossed at the wrists
Keep their feet flat on the floor
Keep their back straight and keep their arms against your chest
On "Go," rise to a full standing position and then sit back down again
Repeat this for 30 seconds
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.
Time Frame
4 weeks
Title
Change in vitals and distance walked via 6-minute walk test
Description
The change in the participant's 6-minute walk test metrics (vitals and distance walked)
Participant's baseline vitals will be recorded, including pulse oximetry prior to walking
Participant will walk as far as possible in 6 minutes at a comfortable pace, but not at a run or jog.
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.
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.
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of grip exercises
Description
Participants will complete and record number of stress ball squeezes (Squeezing stress ball in hand and holding it squeezed for 5 seconds) during the prehabilitation period
Number of times squeezed with right hand and number of times squeezed with left hand will be recorded.
Time Frame
4 weeks
Title
Number of chair sit stands performed
Description
Measures lower body strength: Participants will measure the number of chair sit stands they perform in a day during the prehabilitation period.
Time Frame
4 weeks
Title
Number of steps walked
Description
Participants will track the number of steps they walk per day during the prehabilitation period via the provided fitness activity tracker (Garmin Vivofit 4).
Time Frame
4 weeks
Title
Heart rate
Description
Participants will track their heart rate during the prehabilitation period via the provided fitness activity tracker (Garmin Vivofit 4).
Time Frame
4 weeks
Title
Energy expenditure
Description
Participant's energy expenditure will be tracked via the data from the supplied fitness tracker (Garmin Vivofit 4).
Time Frame
4 weeks
Title
Weight change from the baseline
Description
Participant's weight change from the baseline initial consultation to the day of operation will be recorded.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Walsh, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prehabilitation in Pancreatic Surgery
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