Prehabilitation in Pancreatic Surgery
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|ClinicalTrials.gov Identifier: NCT03688867|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : August 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Resection Preoperative Frailty||Behavioral: Prehabilitation regimen||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
Experimental: At-home prehabilitation regimen
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.
- 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:
- 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) [ 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:
- 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 [ Time Frame: 4 weeks ]
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
- 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.
- 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.
- 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).
- 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).
- Energy expenditure [ Time Frame: 4 weeks ]Participant's energy expenditure will be tracked via the data from the supplied fitness tracker (Garmin Vivofit 4).
- 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.
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
|Contact: Matthew Walsh, MD||886-223-8100||CancerCenterResearch@ccf.org|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Matthew Walsh, MD||The Cleveland Clinic|