About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Urothelial cell cancer of the bladder
Treatment with radical cystectomy
Disqualifiers
Need for walking aid
Depression
cardiovascular, neuromuscular or orthopaedic deficites / disorders
Time to surgery < 3 Weeks
Trial design
Parallel
Treatments tested in this trial
Physical Activity
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Perioperative Complications
Complications that occur during the postoperative hospital stay
Secondary outcomes
Physical Fitness Gripstrength
Kg
HRQOL EORTC-QLQC30
Score indicating quality of life in different subscales: symptoms and functioning scores. Scores reach from 0 to 100. 0 indicating no symptoms in the respective scale, 100 representing a strong symptom. For functioning scores 100 indicate a good functioning, 0 indicate no functioning.
Patients in need for analgesia
The type of medication as well as dosage and times the patient need the medication.
6 Minute Walking Test
Walking distance in meters in 6 minutes
Sponsors and contacts
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