Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct) (PreAct)

Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct)

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Bladder Urothelial Carcinoma; Bladder Neoplasm
• Intervention / Treatment: Device: Daily Activity Goal and Feedback

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".

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl-Friedrich Kowalewski, PD Dr. med.; Phone Number: 0152-53404943; Email: karl-friedrich.kowalewski@umm.de
• Study Contact Backup: Name: Johannes Kilz; Phone Number: 0162-5297396; Email: johanneskilz@stud.uni-heidelberg.de

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Recruiting
      • Department of Urology, University Medical Center Mannheim, University of Heidelberg
      • Principal Investigator: Karl-Friedrich Kowalewski, M.D.
      • Contact: Karl-Friedrich Kowalewski, M.D., M.Sc.; Email: karl-friedrich-kowalewski@umm.de
  • Bayern
    • München, Bayern, Germany
      • Recruiting
      • Urologische Klinik München Planegg (UKMP)
      • Contact: Maximilian C. Kriegmair, M.D.; Email: maximilian.kriegmair@ukmp.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Daily Activity Goal and Feedback; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of steps per day	Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.	Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of steps	Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.	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.	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	On postoperative day 30 and 90
Operating time	In minutes, incision - surgical incision closure	On the day of surgery
Blod loss	In millilitres	On the day of surgery
Required transfusion of blood products	Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma	On the day of surgery
Feasibility of the planned urinary diversion	Yes or no	On the day of surgery
Conversion rate	If the planned urinary diversion is not feasible	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)	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	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	On postoperative day 90 if occured
Reoperation rate	Reoperation due to a complication of the radical cystectomy	On postoperative day 90 if occured
Length of stay in the intensive care unit (ICU)	Days spent in the ICU after surgery	On postoperative day 90 if occured

Collaborators and Investigators

• Sponsor: Universitätsmedizin Mannheim
• Collaborators: Dr. Rolf M. Schwiete Foundation
• Investigators: Principal Investigator: Karl-Friedrich Kowalewski, PD Dr. med, Department of Urology, University Medical Center Mannheim, Heidelberg University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): March 14, 2025
• Study Completion (Estimated): March 14, 2026

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Cystectomy; Frailty; Preoperative Exercise; Fitness Trackers
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2021-677

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No