Prehabilitation in Pancreatic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in grip strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing pancreatic resection over a six-month enrollment
排除标准
- •unable to sign a consent
- •require a translator in order to sign the consent
- •Non-pancreatic resection candidates
研究组 & 干预措施
At-home prehabilitation regimen
- 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.
干预措施: Prehabilitation regimen (Behavioral)
结局指标
主要结局
Change in grip strength
时间窗: 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
Change in number of chair stands in 30 seconds (chair stand test)
时间窗: 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.
Change in vitals and distance walked via 6-minute walk test
时间窗: 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
次要结局
- 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)
- Weight change from the baseline(4 weeks)