Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Number of steps per day
研究概览
简要总结
A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.
详细描述
The goal of the PreAct study is to test whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy with a daily activity goal and feedback on the achievement of this goal improves the participants' physical activity up to the day of radical cystectomy.
In addition to the fitness tracker, we provide each patient with a smartphone. For each fitness tracker a separate account in a fitness application is set up for (e.g. name: tracker1.0 with the corresponding e-mail address and password). Neither the patients in the Daily activity Goal and Feedback arm nor the No Daily Activity Goal or Feedback arm receive the access data to the accounts. However, the patients in the intervention group receive the access PIN for the smartphone. On this smartphone a messaging service and the fitness application are installed. The patient thus receives, for example the wristband tracker1.0, which is registered with the corresponding access data in the fitness application of the smartphone given to them. For the entire preoperative period, the Bluetooth function on the smartphone must always stay activated so that the fitness application and the fitness tracker are continuously connected to each other. A detailed description of the timing and implementation of the intervention are described in "Study design" and "Arm and Interventions".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned radical cystectomy with bilateral pelvic lymphadenectomy and one of the different forms of urinary diversion (continent vs. incontinent; orthotopic vs. heterotopic) in patients with bladder cancer
- •Participants age ≥ 18 years and capacity to consent
- •Mobile participant who is not dependent on a walking aid
- •The participant declares his or her consent to participate in this study by signing and dating the informed consent form prior to the surgical procedure
排除标准
- •Karnofsky performance status scale ≤ 70% (with 70%: Care for self. Unable to carry on normal activity or to do active work (Ambulatory and capable of all selfcare but unable to carry out any work activities). ) (Range: 0 - 100 percent with 0 percent "participant´s death" and 100 percent "no disabilities"
- •ASA Physical Status Classification: ASA > 3 (3: A patient with severe systemic disease)
- •ASA 1, 2, 3 if acute or chronic diseases of the musculoskeletal system or the central nervous system are involved that result in a symptomatic restriction of motor and / or, in the last case, neurological function (healing ruptures and fractures, Parkinson's disease, multiple sclerosis, etc.)
- •Emergency intervention
研究组 & 干预措施
Daily Activity Goal and Feedback
The participants in the Daily Activity Goal and Feedback arm receive a defined daily activity goal in the form of a defined number of steps, feedback on the achievement of this goal, and push-up notifications sent directly to the wristband to encourage them to remain active.
干预措施: Daily Activity Goal and Feedback (Device)
No Daily Activity Goal or Feedback
The display of the fitness wristbands of the No Daily Activity Goal or Feedback arm is covered up. The participants in this arm neither receive a daily activity goal nor get feedback on the achievement of the activity goal/push-up notifications.
结局指标
主要结局
Number of steps per day
时间窗: Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.
Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
次要结局
- Operating time(On the day of surgery)
- Reoperation rate(On postoperative day 90 if occured)
- Blod loss(On the day of surgery)
- Length of stay in the intensive care unit (ICU)(On postoperative day 90 if occured)
- Total number of steps(Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down.)
- Patient Reported Outcome Measures (PROMs)(On the day of randomization at the premedication appointment and on the day of discharge which is on average 2 weeks after the surgery and postoperative day 30 and 90)
- Readmission rate(On postoperative day 90 if occured)
- Postoperative physical activity(Morning of postoperative day 4 at 7 PM)
- Postoperative Complications(On postoperative day 30 and 90)
- Required transfusion of blood products(On the day of surgery)
- Length of hospital stay (LOS)(On the day of discharge which is on average 2 weeks after the surgery)
- Feasibility of the planned urinary diversion(On the day of surgery)
- Conversion rate(On the day of surgery)
研究者
Karl-Friedrich Kowalewski
Managing Senior Physician
Universitätsmedizin Mannheim