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Trial Title:
Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)
NCT ID:
NCT06416319
Condition:
Bladder Cancer
Bladder Neoplasm
Bladder Urothelial Carcinoma
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Cystectomy
Preoperative Exercise
Fitness Trackers
Exercise
Frailty
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Daily Activity Goal and Feedback
Description:
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.
Arm group label:
Daily Activity Goal and Feedback
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".
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Urology, University Medical Center Mannheim, University of Heidelberg
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Karl-Friedrich Kowalewski, M.D., M.Sc.
Email:
karl-friedrich-kowalewski@umm.de
Investigator:
Last name:
Karl-Friedrich Kowalewski, M.D.
Email:
Principal Investigator
Facility:
Name:
Urologische Klinik München Planegg (UKMP)
Address:
City:
München
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Maximilian C. Kriegmair, M.D.
Email:
maximilian.kriegmair@ukmp.de
Start date:
March 14, 2023
Completion date:
March 14, 2026
Lead sponsor:
Agency:
Universitätsmedizin Mannheim
Agency class:
Other
Collaborator:
Agency:
Dr. Rolf M. Schwiete Foundation
Agency class:
Other
Source:
Universitätsmedizin Mannheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06416319
