Bladder CancerPreActNCT06416319
Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)
A study testing Daily Activity Goal and Feedback in people with Bladder Cancer and Bladder Neoplasm, run by Universitätsmedizin Mannheim at 2 sites in Germany.
Trial summary
A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma
- What is being tested?
- Daily Activity Goal and Feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesGermany
- Study dates
- 14 Mar 2023to 14 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Planned radical cystectomy with bilateral pelvic lymphadenectomy and one of the different forms of urinary diversion (continent vs. incontinent; orthotopic vs. heterotopic) in patients with bladder cancer
- Participants age ≥ 18 years and capacity to consent
- Mobile participant who is not dependent on a walking aid
- The participant declares his or her consent to participate in this study by signing and dating the informed consent form prior to the surgical procedure
Who cannot join
- Karnofsky performance status scale ≤ 70% (with 70%: Care for self. Unable to carry on normal activity or to do active work (Ambulatory and capable of all selfcare but unable to carry out any work activities). ) (Range: 0 - 100 percent with 0 percent "participant´s death" and 100 percent "no disabilities"
- ASA Physical Status Classification: ASA > 3 (3: A patient with severe systemic disease)
- ASA 1, 2, 3 if acute or chronic diseases of the musculoskeletal system or the central nervous system are involved that result in a symptomatic restriction of motor and / or, in the last case, neurological function (healing ruptures and fractures, Parkinson's disease, multiple sclerosis, etc.)
- Emergency intervention
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Department of Urology, University Medical Center Mannheim, University of Heidelberg
Mannheim, Baden-Wurttemberg, 68167
Karl-Friedrich Kowalewski, M.D., M.Sc., karl-friedrich-kowalewski@umm.de
Karl-Friedrich Kowalewski, M.D.
- Recruiting
Urologische Klinik München Planegg (UKMP)
München, Bavaria
Maximilian C. Kriegmair, M.D., maximilian.kriegmair@ukmp.de
About this study
Official title: Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct)
A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.
Read the detailed description
The goal of the PreAct study is to test whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy with a daily activity goal and feedback on the achievement of this goal improves the participants' physical activity up to the day of radical cystectomy.
In addition to the fitness tracker, we provide each patient with a smartphone. For each fitness tracker a separate account in a fitness application is set up for (e.g. name: tracker1.0 with the corresponding e-mail address and password). Neither the patients in the Daily activity Goal and Feedback arm nor the No Daily Activity Goal or Feedback arm receive the access data to the accounts. However, the patients in the intervention group receive the access PIN for the smartphone. On this smartphone a messaging service and the fitness application are installed. The patient thus receives, for example the wristband tracker1.0, which is registered with the corresponding access data in the fitness application of the smartphone given to them. For the entire preoperative period, the Bluetooth function on the smartphone must always stay activated so that the fitness application and the fitness tracker are continuously connected to each other. A detailed description of the timing and implementation of the intervention are described in "Study design" and "Arm and Interventions".
- Being tested
- Daily Activity Goal and Feedback
- Keywords
- Cystectomy, Preoperative Exercise, Fitness Trackers, Exercise, Frailty
- Medical subject headings
- Urinary Bladder Neoplasms, Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Activity Goal and FeedbackDevice
The daily activity target is a fixed number of steps. The exact number of steps is determined beforehand as part of the case number planning in a pilot study with ten participants and adjusted if necessary. The activity target we suggest is 8000 steps. In addition, the participants receive feedback several times a day about the steps needed to reach the goal and whether they have ultimately reached the daily goal.
| Study group | Role | What they receive |
|---|---|---|
| Daily Activity Goal and Feedback | Experimental | The participants in the Daily Activity Goal and Feedback arm receive a defined daily activity goal in the form of a defined number of steps, feedback on the achievement of this goal, and push-up notifications sent directly to the wristband to encourage them to remain active. Receives: Device: Daily Activity Goal and Feedback |
| No Daily Activity Goal or Feedback | No intervention | The display of the fitness wristbands of the No Daily Activity Goal or Feedback arm is covered up. The participants in this arm neither receive a daily activity goal nor get feedback on the achievement of the activity goal/push-up notifications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps per day
Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
Measured: Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.
Secondary outcomes (13)
Total number of steps
Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
Measured: Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down.
Postoperative physical activity
The postoperative physical activity of the participants measured by the average number of steps per day and in total on postoperative days 1 to 3. Neither arm will receive a daily activity goal. However, the fitness trackers of the No Daily Activity Goal or Feedback arm are still covered.
Measured: Morning of postoperative day 4 at 7 PM
Postoperative Complications
Postoperative complications measured by the Comprehensive Classification Index (CCI), on a scale from 0 (no complications) to 100 (death), (Slankamenac, Graf et al. 2013) and the Clavien-Dindo Classification (CDC), which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death (Clavien, Barkun et al. 2009):
CDC ≥ 3a corresponding to a CCI ≥ 26.2 defined as "severe complications" including CDC = 5 and CCI = 100 defined as "patient's death" and the total number of complications
Measured: On postoperative day 30 and 90
Operating time
In minutes, incision - surgical incision closure
Measured: On the day of surgery
Blod loss
In millilitres
Measured: On the day of surgery
Required transfusion of blood products
Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma
Measured: On the day of surgery
Feasibility of the planned urinary diversion
Yes or no
Measured: On the day of surgery
Conversion rate
If the planned urinary diversion is not feasible
Measured: On the day of surgery
Patient Reported Outcome Measures (PROMs)
SF-36: Health-related quality of life (Scale 0 - 100: The higher the score, the lower the disability. A score of 100 corresponds to no disability)
Measured: On the day of randomization at the premedication appointment and on the day of discharge which is on average 2 weeks after the surgery and postoperative day 30 and 90
Length of hospital stay (LOS)
LOS measured by the number of days spent in the hospital after surgery until discharge
Measured: On the day of discharge which is on average 2 weeks after the surgery
Readmission rate
Readmissions due to a complication of the radical cystectomy
Measured: On postoperative day 90 if occured
Reoperation rate
Reoperation due to a complication of the radical cystectomy
Measured: On postoperative day 90 if occured
Length of stay in the intensive care unit (ICU)
Days spent in the ICU after surgery
Measured: On postoperative day 90 if occured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 Mar 2023
- Primary completion14 Mar 2025 (estimated)
- Study completion14 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with an indication for radical cystectomy are included in this study. Recruitment, including eligibility criteria testing and randomized allocation to the intervention or control group, will take place on the day of premedication approximately 7 to 10 days prior to surgery. This period represents the prehabilitation period.
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Rolf M. Schwiete Foundation
- Responsible party
- Principal investigator, Karl-Friedrich Kowalewski, Universitätsmedizin Mannheim
- Investigators
- Karl-Friedrich Kowalewski, PD Dr. med, Principal investigator, Department of Urology, University Medical Center Mannheim, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416319
- Sponsor's protocol ID
- 2021-677
- Acronym
- PreAct
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct)
- ClinicalTrials.gov ID
- NCT06416319
- Acronym / sponsor ID
- PreAct / 2021-677
- Keywords
- Cystectomy, Preoperative Exercise, Fitness Trackers, Exercise, Frailty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- Dr. Rolf M. Schwiete Foundation
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 14 Mar 2026 (estimated)
- First posted
- 16 May 2024 (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.
A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.
Detailed description
The goal of the PreAct study is to test whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy with a daily activity goal and feedback on the achievement of this goal improves the participants' physical activity up to the day of radical cystectomy.
In addition to the fitness tracker, we provide each patient with a smartphone. For each fitness tracker a separate account in a fitness application is set up for (e.g. name: tracker1.0 with the corresponding e-mail address and password). Neither the patients in the Daily activity Goal and Feedback arm nor the No Daily Activity Goal or Feedback arm receive the access data to the accounts. However, the patients in the intervention group receive the access PIN for the smartphone. On this smartphone a messaging service and the fitness application are installed. The patient thus receives, for example the wristband tracker1.0, which is registered with the corresponding access data in the fitness application of the smartphone given to them. For the entire preoperative period, the Bluetooth function on the smartphone must always stay activated so that the fitness application and the fitness tracker are continuously connected to each other. A detailed description of the timing and implementation of the intervention are described in "Study design" and "Arm and Interventions".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with an indication for radical cystectomy are included in this study. Recruitment, including eligibility criteria testing and randomized allocation to the intervention or control group, will take place on the day of premedication approximately 7 to 10 days prior to surgery. This period represents the prehabilitation period.
| Arm | Type | Receives |
|---|---|---|
| Daily Activity Goal and Feedback | Experimental | Device: Daily Activity Goal and FeedbackThe participants in the Daily Activity Goal and Feedback arm receive a defined daily activity goal in the form of a defined number of steps, feedback on the achievement of this goal, and push-up notifications sent directly to the wristband to encourage them to remain active. |
| No Daily Activity Goal or Feedback | No intervention | –The display of the fitness wristbands of the No Daily Activity Goal or Feedback arm is covered up. The participants in this arm neither receive a daily activity goal nor get feedback on the achievement of the activity goal/push-up notifications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned radical cystectomy with bilateral pelvic lymphadenectomy and one of the different forms of urinary diversion (continent vs. incontinent; orthotopic vs. heterotopic) in patients with bladder cancer
- Participants age ≥ 18 years and capacity to consent
- Mobile participant who is not dependent on a walking aid
- The participant declares his or her consent to participate in this study by signing and dating the informed consent form prior to the surgical procedure
Key exclusion criteria (4 listed)
- Karnofsky performance status scale ≤ 70% (with 70%: Care for self. Unable to carry on normal activity or to do active work (Ambulatory and capable of all selfcare but unable to carry out any work activities). ) (Range: 0 - 100 percent with 0 percent "participant´s death" and 100 percent "no disabilities"
- ASA Physical Status Classification: ASA > 3 (3: A patient with severe systemic disease)
- ASA 1, 2, 3 if acute or chronic diseases of the musculoskeletal system or the central nervous system are involved that result in a symptomatic restriction of motor and / or, in the last case, neurological function (healing ruptures and fractures, Parkinson's disease, multiple sclerosis, etc.)
- Emergency intervention
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 |
|---|---|---|
| Daily Activity Goal and FeedbackThe daily activity target is a fixed number of steps. The exact number of steps is determined beforehand as part of the case number planning in a pilot study with ten participants and adjusted if necessary. The activity target we suggest is 8000 steps. In addition, the participants receive feedback several times a day about the steps needed to reach the goal and whether they have ultimately reached the daily goal. | Device | Daily Activity Goal and Feedback |
Primary outcome
Number of steps per day
Time frame: Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.
Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
13 secondary outcomes
Total number of steps
Time frame: Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down.
Postoperative physical activity
Time frame: Morning of postoperative day 4 at 7 PM
Postoperative Complications
Time frame: On postoperative day 30 and 90
Operating time
Time frame: On the day of surgery
Blod loss
Time frame: On the day of surgery
Required transfusion of blood products
Time frame: On the day of surgery
Feasibility of the planned urinary diversion
Time frame: On the day of surgery
Conversion rate
Time frame: On the day of surgery
Patient Reported Outcome Measures (PROMs)
Time frame: On the day of randomization at the premedication appointment and on the day of discharge which is on average 2 weeks after the surgery and postoperative day 30 and 90
Length of hospital stay (LOS)
Time frame: On the day of discharge which is on average 2 weeks after the surgery
Readmission rate
Time frame: On postoperative day 90 if occured
Reoperation rate
Time frame: On postoperative day 90 if occured
Length of stay in the intensive care unit (ICU)
Time frame: On postoperative day 90 if occured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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. This study is not recruiting at the moment.
Karl-Friedrich Kowalewski, PD Dr. med principal investigator
Department of Urology, University Medical Center Mannheim, Heidelberg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Activity Goal and Feedback in people with Bladder Cancer and Bladder Neoplasm, run by Universitätsmedizin Mannheim at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl-Friedrich Kowalewski, PD Dr. med. (0152-53404943, karl-friedrich.kowalewski@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps per day (time frame: Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.). 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 16 May 2024.