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.
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".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
The daily activity target is a fixed number of steps. The exact number of steps is determined beforehand as part of the case number planning in a pilot study with ten participants and adjusted if necessary. The activity target we suggest is 8000 steps. In addition, the participants receive feedback several times a day about the steps needed to reach the goal and whether they have ultimately reached the daily goal.
Department of Urology, University Medical Center Mannheim, University of Heidelberg
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGUrologische Klinik München Planegg (UKMP)
München, Bavaria, Germany
RECRUITINGNumber of steps per day
Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
Time frame: Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.
Total number of steps
Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
Time frame: Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down.
Postoperative physical activity
The postoperative physical activity of the participants measured by the average number of steps per day and in total on postoperative days 1 to 3. Neither arm will receive a daily activity goal. However, the fitness trackers of the No Daily Activity Goal or Feedback arm are still covered.
Time frame: Morning of postoperative day 4 at 7 PM
Postoperative Complications
Postoperative complications measured by the Comprehensive Classification Index (CCI), on a scale from 0 (no complications) to 100 (death), (Slankamenac, Graf et al. 2013) and the Clavien-Dindo Classification (CDC), which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death (Clavien, Barkun et al. 2009): CDC ≥ 3a corresponding to a CCI ≥ 26.2 defined as "severe complications" including CDC = 5 and CCI = 100 defined as "patient's death" and the total number of complications
Time frame: On postoperative day 30 and 90
Operating time
In minutes, incision - surgical incision closure
Time frame: On the day of surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blod loss
In millilitres
Time frame: On the day of surgery
Required transfusion of blood products
Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma
Time frame: On the day of surgery
Feasibility of the planned urinary diversion
Yes or no
Time frame: On the day of surgery
Conversion rate
If the planned urinary diversion is not feasible
Time frame: On the day of surgery
Patient Reported Outcome Measures (PROMs)
SF-36: Health-related quality of life (Scale 0 - 100: The higher the score, the lower the disability. A score of 100 corresponds to no disability)
Time frame: 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
Length of hospital stay (LOS)
LOS measured by the number of days spent in the hospital after surgery until discharge
Time frame: On the day of discharge which is on average 2 weeks after the surgery
Readmission rate
Readmissions due to a complication of the radical cystectomy
Time frame: On postoperative day 90 if occured
Reoperation rate
Reoperation due to a complication of the radical cystectomy
Time frame: On postoperative day 90 if occured
Length of stay in the intensive care unit (ICU)
Days spent in the ICU after surgery
Time frame: On postoperative day 90 if occured