Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prehabilitation in Pancreatic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688867
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Pancreatic Resection Preoperative Frailty Behavioral: Prehabilitation regimen Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prehabilitation in Pancreatic Surgery
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Experimental: 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.
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.





Primary Outcome Measures :
  1. Change in grip strength [ Time Frame: 4 weeks ]

    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

  2. Change in number of chair stands in 30 seconds (chair stand test) [ Time Frame: 4 weeks ]

    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.

  3. Change in vitals and distance walked via 6-minute walk test [ Time Frame: 4 weeks ]

    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



Secondary Outcome Measures :
  1. Number of grip exercises [ Time Frame: 4 weeks ]

    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.


  2. Number of chair sit stands performed [ Time Frame: 4 weeks ]
    Measures lower body strength: Participants will measure the number of chair sit stands they perform in a day during the prehabilitation period.

  3. Number of steps walked [ Time Frame: 4 weeks ]
    Participants will track the number of steps they walk per day during the prehabilitation period via the provided fitness activity tracker (Garmin Vivofit 4).

  4. Heart rate [ Time Frame: 4 weeks ]
    Participants will track their heart rate during the prehabilitation period via the provided fitness activity tracker (Garmin Vivofit 4).

  5. Energy expenditure [ Time Frame: 4 weeks ]
    Participant's energy expenditure will be tracked via the data from the supplied fitness tracker (Garmin Vivofit 4).

  6. Weight change from the baseline [ Time Frame: 4 weeks ]
    Participant's weight change from the baseline initial consultation to the day of operation will be recorded.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688867


Contacts
Layout table for location contacts
Contact: Matthew Walsh, MD 886-223-8100 CancerCenterResearch@ccf.org

Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Matthew Walsh, MD The Cleveland Clinic
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03688867    
Other Study ID Numbers: CASE4218
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes