Clinical trial NCT03688867: Prehabilitation in Pancreatic Surgery
Official title: Prehabilitation in Pancreatic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Resection
Preoperative Frailty
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in grip strength
timeFrame: 4 weeks
measure: Change in number of chair stands in 30 seconds (chair stand test)
timeFrame: 4 weeks
measure: Change in vitals and distance walked via 6-minute walk test
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of grip exercises
timeFrame: 4 weeks
measure: Number of chair sit stands performed
timeFrame: 4 weeks
measure: Number of steps walked
timeFrame: 4 weeks
measure: Heart rate
timeFrame: 4 weeks
measure: Energy expenditure
timeFrame: 4 weeks
measure: Weight change from the baseline
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Matthew Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: