Clinical trial NCT06416319: Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)
Official title: Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Bladder Neoplasm
Bladder Urothelial Carcinoma
Keywords: Cystectomy
Preoperative Exercise
Fitness Trackers
Exercise
Frailty
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
Collaborators: name: Dr. Rolf M. Schwiete Foundation
First posted: 2024-05-16
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with an indication for radical cystectomy are included in this study. Recruitment, including eligibility criteria testing and randomized allocation to the intervention or control group, will take place on the day of premedication approximately 7 to 10 days prior to surgery. This period represents the prehabilitation period.
Primary purpose: TREATMENT

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".

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of steps per day
timeFrame: Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.
Secondary outcomes:
measure: Total number of steps
timeFrame: Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down.
measure: Postoperative physical activity
timeFrame: Morning of postoperative day 4 at 7 PM
measure: Postoperative Complications
timeFrame: On postoperative day 30 and 90
measure: Operating time
timeFrame: On the day of surgery
measure: Blod loss
timeFrame: On the day of surgery
measure: Required transfusion of blood products
timeFrame: On the day of surgery
measure: Feasibility of the planned urinary diversion
timeFrame: On the day of surgery
measure: Conversion rate
timeFrame: On the day of surgery
measure: Patient Reported Outcome Measures (PROMs)
timeFrame: 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
measure: Length of hospital stay (LOS)
timeFrame: On the day of discharge which is on average 2 weeks after the surgery
measure: Readmission rate
timeFrame: On postoperative day 90 if occured
measure: Reoperation rate
timeFrame: On postoperative day 90 if occured
measure: Length of stay in the intensive care unit (ICU)
timeFrame: On postoperative day 90 if occured
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Department of Urology, University Medical Center Mannheim, University of Heidelberg
state: Baden-Württemberg
city: München
country: Germany
facility: Urologische Klinik München Planegg (UKMP)
state: Bayern
Study officials:
affiliation: Department of Urology, University Medical Center Mannheim, Heidelberg University
name: Karl-Friedrich Kowalewski, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: