Department of Urology, LMU Hospital
Munich, Bavaria, 81377, Germany
Location status: Recruiting
NCT Number: NCT06806059
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.
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All sexes
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Munich, Bavaria, 81377, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From surgery to 90 days postoperatively
Complications that occur during the postoperative hospital stay
Time frame: From the day before the surgery as well as up to 12 months after the surgery
Kg
Time frame: postoperatively, 3 months and 12 months
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: From the day before the surgery up to the discharge from the hospital up to 12 months
The type of medication as well as dosage and times the patient need the medication.
Time frame: During the hospitalisation period until 12 months postoperatively
Walking distance in meters in 6 minutes
Time frame: From the day before the surgery up to the discharge from the Hospital up to 12 months
The type of laxative as well as dosage and times the medication is needed
Contact information is provided by the study sponsor or research team.
Ludwig-Maximilians - University of Munich
Other
Prospective Randomized Interventional Study to Investigate the Impact of Preoperative Physical Activity on Perioperative Morbidity Following Radical Cystectomy
Acronym: PRACTICE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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