RecruitingNot ApplicableNCT06806059

Preoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity

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


Sponsor

Ludwig-Maximilians - University of Munich

Enrollment

146 participants

Start Date

Nov 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Urothelial cell cancer of the bladder
  • Treatment with radical cystectomy

Exclusion Criteria4

  • Need for walking aid
  • Depression
  • cardiovascular, neuromuscular or orthopaedic deficites / disorders
  • Time to surgery < 3 Weeks

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Interventions

BEHAVIORALPhysical 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.


Locations(1)

Department of Urology, LMU Hospital

Munich, Bavaria, Germany

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NCT06806059


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