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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Department of Urology, University Medical Center Mannheim, University of Heidelberg
RECRUITING
Mannheim
Urologische Klinik München Planegg (UKMP)
RECRUITING
München
Contact Information
Primary
Karl-Friedrich Kowalewski, PD Dr. med.
karl-friedrich.kowalewski@umm.de
0152-53404943
Backup
Johannes Kilz
johanneskilz@stud.uni-heidelberg.de
0162-5297396
Time Frame
Start Date: 2023-03-14
Estimated Completion Date: 2026-03-14
Participants
Target number of participants: 164
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Universitätsmedizin Mannheim
Collaborators: Dr. Rolf M. Schwiete Foundation

This content was sourced from clinicaltrials.gov