Urothelial Carcinoma BladderPRACTICENCT06806059
Preoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity
A study testing Physical Activity in people with Urothelial Carcinoma Bladder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma Bladder
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteGermany
- Study dates
- 29 Nov 2024to 29 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urothelial cell cancer of the bladder
- Treatment with radical cystectomy
Who cannot join
- Need for walking aid
- Depression
- cardiovascular, neuromuscular or orthopaedic deficites / disorders
- Time to surgery < 3 Weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Urology, LMU Hospital
Munich, Bavaria, 81377
Yannic Volz, +49 089 4400 75970, yannic.volz@med.uni-muenchen.de
About this study
Official title: Prospective Randomized Interventional Study to Investigate the Impact of Preoperative Physical Activity on Perioperative Morbidity Following Radical Cystectomy
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.
Read the 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
- Being tested
- Physical Activity
- Keywords
- physical activity, preoperative, cystectomy, activity tracker, physical fitness, complication
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Complications
Complications that occur during the postoperative hospital stay
Measured: From surgery to 90 days postoperatively
Secondary outcomes (5)
Physical Fitness Gripstrength
Kg
Measured: From the day before the surgery as well as up to 12 months after the surgery
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.
Measured: postoperatively, 3 months and 12 months
Patients in need for analgesia
The type of medication as well as dosage and times the patient need the medication.
Measured: From the day before the surgery up to the discharge from the hospital up to 12 months
6 Minute Walking Test
Walking distance in meters in 6 minutes
Measured: During the hospitalisation period until 12 months postoperatively
Patients in need of laxatives
The type of laxative as well as dosage and times the medication is needed
Measured: From the day before the surgery up to the discharge from the Hospital up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start29 Nov 2024
- Primary completion29 Nov 2026 (estimated)
- Study completion29 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannic Volz, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806059
- Sponsor's protocol ID
- 24-0096
- Acronym
- PRACTICE
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical and legal obligations
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Interventional Study to Investigate the Impact of Preoperative Physical Activity on Perioperative Morbidity Following Radical Cystectomy
- ClinicalTrials.gov ID
- NCT06806059
- Acronym / sponsor ID
- PRACTICE / 24-0096
- Conditions
- Urothelial Carcinoma Bladder
- Keywords
- physical activity, preoperative, cystectomy, activity tracker, physical fitness, complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical ActivityThe 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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Urothelial cell cancer of the bladder
- Treatment with radical cystectomy
Key exclusion criteria (4 listed)
- Need for walking aid
- Depression
- cardiovascular, neuromuscular or orthopaedic deficites / disorders
- Time to surgery < 3 Weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityThe 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. | Behavioural | Physical Activity |
Primary outcome
Perioperative Complications
Time frame: From surgery to 90 days postoperatively
Complications that occur during the postoperative hospital stay
5 secondary outcomes
Physical Fitness Gripstrength
Time frame: From the day before the surgery as well as up to 12 months after the surgery
HRQOL EORTC-QLQC30
Time frame: postoperatively, 3 months and 12 months
Patients in need for analgesia
Time frame: From the day before the surgery up to the discharge from the hospital up to 12 months
6 Minute Walking Test
Time frame: During the hospitalisation period until 12 months postoperatively
Patients in need of laxatives
Time frame: From the day before the surgery up to the discharge from the Hospital up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No. Ethical and legal obligations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Urothelial Carcinoma Bladder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannic Volz, PD Dr. med. (+49 089 4400 75970, yannic.volz@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Complications (time frame: From surgery to 90 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.