Clinical trial NCT06806059: Preoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity
Official title: Prospective Randomized Interventional Study to Investigate the Impact of Preoperative Physical Activity on Perioperative Morbidity Following Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urothelial Carcinoma Bladder
Keywords: physical activity
preoperative
cystectomy
activity tracker
physical fitness
complication
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Perioperative Complications
timeFrame: From surgery to 90 days postoperatively
Secondary outcomes:
measure: Physical Fitness Gripstrength
timeFrame: From the day before the surgery as well as up to 12 months after the surgery
measure: HRQOL EORTC-QLQC30
timeFrame: postoperatively, 3 months and 12 months
measure: Patients in need for analgesia
timeFrame: From the day before the surgery up to the discharge from the hospital up to 12 months
measure: 6 Minute Walking Test
timeFrame: During the hospitalisation period until 12 months postoperatively
measure: Patients in need of laxatives
timeFrame: From the day before the surgery up to the discharge from the Hospital up to 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Urology, LMU Hospital
state: Bavaria
Study officials:
References: