Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)
- Conditions
- Bladder NeoplasmBladder CancerBladder Urothelial Carcinoma
- Interventions
- Device: Daily Activity Goal and Feedback
- Registration Number
- NCT06416319
- Lead Sponsor
- Universitätsmedizin Mannheim
- Brief Summary
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.
- Detailed Description
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".
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 164
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daily Activity Goal and Feedback 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.
- Primary Outcome Measures
Name Time Method Number of steps per day 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.
- Secondary Outcome Measures
Name Time Method Operating time On the day of surgery In minutes, incision - surgical incision closure
Reoperation rate On postoperative day 90 if occured Reoperation due to a complication of the radical cystectomy
Blod loss On the day of surgery In millilitres
Length of stay in the intensive care unit (ICU) On postoperative day 90 if occured Days spent in the ICU after surgery
Total number of steps Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down. Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
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 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)
Readmission rate On postoperative day 90 if occured Readmissions due to a complication of the radical cystectomy
Postoperative physical activity Morning of postoperative day 4 at 7 PM 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.
Postoperative Complications On postoperative day 30 and 90 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 complicationsRequired transfusion of blood products On the day of surgery Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma
Length of hospital stay (LOS) On the day of discharge which is on average 2 weeks after the surgery LOS measured by the number of days spent in the hospital after surgery until discharge
Feasibility of the planned urinary diversion On the day of surgery Yes or no
Conversion rate On the day of surgery If the planned urinary diversion is not feasible
Trial Locations
- Locations (2)
Urologische Klinik München Planegg (UKMP)
🇩🇪München, Bayern, Germany
Department of Urology, University Medical Center Mannheim, University of Heidelberg
🇩🇪Mannheim, Baden-Württemberg, Germany