Prospective Randomized Interventional Study to Investigate the Impact of Preoperative Physical Activity on Perioperative Morbidity Following Radical Cystectomy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Bladder cancer (BC) is the 6th most common tumor in Europe, with over 540,000 new cases globally each year. While 75% of cases are non-muscle-invasive and treated bladder-preservingly, muscle-invasive, non-metastatic BC requires radical cystectomy (RC), often with neoadjuvant chemotherapy. RC has one of the highest complication rates in urology, and rehabilitation focuses on mitigating functional impairments, restoring physical and mental capacity, and enabling a swift return to daily life. The ERAS (Enhanced Recovery After Surgery) protocol has shown benefits in reducing hospital stays without increasing complications in RC. Prehabilitation studies in cancer patients have demonstrated improvements in strength and fitness, though without significant reductions in complications or mortality. This prospective randomized study, conducted over three years at the University of Munich, will evaluate the effect of preoperative physical activity on perioperative morbidity (primary endpoint). Secondary endpoints include quality of life, hospital stay, mortality, and postoperative physical activity. The intervention group will target 8,000-10,000 daily steps for four weeks preoperatively, monitored via pedometers. Follow-ups will assess physical activity and quality of life at specific intervals pre- and post-surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Urothelial cell cancer of the bladder

• Treatment with radical cystectomy

Locations
Other Locations
Germany
Department of Urology, LMU Hospital
RECRUITING
Munich
Contact Information
Primary
Yannic Volz, PD Dr. med.
yannic.volz@med.uni-muenchen.de
+49 089 4400 75970
Time Frame
Start Date: 2024-11-29
Estimated Completion Date: 2027-11-29
Participants
Target number of participants: 146
Treatments
Experimental: Physical Activity
The intervention group will engage in increased physical activity, aiming for a daily step count of at least 8,000, with a target of 10,000 steps, over a four-week preoperative period. Weekly supervised phone consultations will be conducted to provide guidance and support.
No_intervention: Controll
The control group will track their daily physical activity without being required to meet a specific step target. Weekly phone consultations will still be conducted to monitor and support the participants.
Related Therapeutic Areas
Sponsors
Leads: Ludwig-Maximilians - University of Munich

This content was sourced from clinicaltrials.gov