Preoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity

NCT06806059 | Recruiting

• 1 other identifier: 24-0096
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urothelial Carcinoma Bladder

Keywords

physical activity; preoperative; cystectomy; activity tracker; physical fitness; complication

Outcome Measures

Primary Outcomes (1)

• Perioperative Complications

  Complications that occur during the postoperative hospital stay

  From surgery to 90 days postoperatively

Secondary Outcomes (5)

• Physical Fitness Gripstrength

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

• HRQOL EORTC-QLQC30

  postoperatively, 3 months and 12 months

• Patients in need for analgesia

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

• 6 Minute Walking Test

  During the hospitalisation period until 12 months postoperatively

• Patients in need of laxatives

  From the day before the surgery up to the discharge from the Hospital up to 12 months

Study Arms (2)

Physical Activity

EXPERIMENTAL

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.

Behavioral: Physical Activity

Controll

NO INTERVENTION

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.

Interventions

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.

Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Urology, LMU Hospital

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yannic Volz, PD Dr. med.

CONTACT

+49 089 4400 75970; yannic.volz@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 3, 2025
• Study Start: November 29, 2024
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): November 29, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)