RecruitingNot ApplicableNCT06416319

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

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


Sponsor

Universitätsmedizin Mannheim

Enrollment

164 participants

Start Date

Mar 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a fitness tracker (activity monitor) to increase physical activity before bladder removal surgery (radical cystectomy) can improve patients' fitness levels and help them recover better after the operation. **You may be eligible if...** - You have bladder cancer and are scheduled for radical cystectomy (surgical removal of the bladder) - You are 18 or older - You are mobile and can walk without a walking aid - You are willing and able to give your consent **You may NOT be eligible if...** - You have a low functional performance score (Karnofsky score at or below 70%) indicating significant health limitations - You have a severe physical health classification (ASA grade above 3) - You have conditions affecting your movement, such as active fractures, Parkinson's disease, or multiple sclerosis - You need emergency surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDaily 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.


Locations(2)

Department of Urology, University Medical Center Mannheim, University of Heidelberg

Mannheim, Baden-Wurttemberg, Germany

Urologische Klinik München Planegg (UKMP)

München, Bavaria, Germany

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NCT06416319


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