Preoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLudwig-Maximilians - University of Munich

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Physical Activity

    Behavioral

    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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Physical ActivityExperimental treatment 1 intervention
Group B: ControllNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Perioperative Complications

Complications that occur during the postoperative hospital stay

Time frame
From surgery to 90 days postoperatively

Secondary outcomes

1

Physical Fitness Gripstrength

Kg

Time frame
From the day before the surgery as well as up to 12 months after the surgery
2

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.

Time frame
postoperatively, 3 months and 12 months
3

Patients in need for analgesia

The type of medication as well as dosage and times the patient need the medication.

Time frame
From the day before the surgery up to the discharge from the hospital up to 12 months
4

6 Minute Walking Test

Walking distance in meters in 6 minutes

Time frame
During the hospitalisation period until 12 months postoperatively

Other outcomes

Sponsors and contacts

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