Preoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity

NCT ID: NCT06806059

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-29
• Study Completion Date: 2027-11-29

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.

Detailed Description

In Europe, bladder cancer (BC) is the 6th most common tumor entity. Globally, over 540,000 new cases have been reported annually in recent years. Approximately 75% of cases are diagnosed as non-muscle-invasive BC at initial presentation, which can generally be treated in a bladder-preserving manner through transurethral resection and intravesical therapy. In cases of muscle-invasive, non-metastatic BC, guidelines recommend radical cystectomy (RC) with neoadjuvant chemotherapy in a curative setting, provided the patient is suitable for such treatment. Considering comorbidities, mortality, and quality of life, various forms of urinary diversion are employed during RC. These include incontinent diversions, such as ileal or colonic conduits, and continent diversions, such as orthotopic bladder replacement using the ileum (neobladder).

A direct comparison of these different urinary diversion methods is currently challenging due to a lack of data. RC is associated with one of the highest complication rates among urological procedures. Rehabilitation following RC must focus on addressing postoperative functional impairments, restoring physical and mental performance, and facilitating a prompt return to social and professional life. The ERAS (Enhanced Recovery After Surgery) concept, originally established in colorectal surgery, has also demonstrated reduced overall hospital stays in RC without increasing complication rates. While it remains uncertain whether the ERAS concept improves prognosis and morbidity, it is considered safe, as no studies have reported an increase in severe complications or mortality associated with its implementation.

Studies in visceral surgery involving prehabilitation for patients with colorectal, esophageal, and lung cancers have shown functional benefits, such as improved fitness, mobility, and strength, but without reductions in complication rates or mortality. In a randomized controlled trial, Minella EM et al. demonstrated the effectiveness of prehabilitation in improving functional outcomes, such as strength and endurance, in BC patients undergoing RC. However, no significant differences in postoperative complications or mortality were observed. A recent prospective study involving patients prior to RC also reported significant improvements in strength and functional fitness.

In the prospective randomized study presented here for evaluation, the investigators aim to investigate the impact of preoperative physical activity on perioperative morbidity (primary endpoint). Secondary endpoints include quality of life, length of hospital stay, mortality, and postoperative physical activity. The intervention group will undergo preoperative preparation over four weeks, targeting a daily step count of 8,000-10,000. Step counts will be self-monitored by patients using pedometers. Physical activity and quality of life will be assessed at specific time points using established fitness assessments and questionnaires. Comparative follow-ups will take place four weeks before surgery, the day before surgery, one week postoperatively, and at three and twelve months postoperatively.

The study will be conducted as a single-center trial at the Department of Urology at the University of Munich over a three-year period.

Conditions

Urothelial Carcinoma Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Yannic Volz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Urology, LMU Hospital

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Yannic Volz, PD Dr. med.

Role: CONTACT

yannic.volz@med.uni-muenchen.de

+49 089 4400 75970

Facility Contacts

Yannic Volz

Role: primary

yannic.volz@med.uni-muenchen.de

+49 089 4400 75970

Other Identifiers

24-0096

Identifier Type: -

Identifier Source: org_study_id