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| Name | Class |
|---|---|
| Dr. Rolf M. Schwiete Foundation | UNKNOWN |
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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.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Activity Goal and Feedback | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of steps | Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery. | Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down. |
| Postoperative physical activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl-Friedrich Kowalewski, PD Dr. med. | Contact | 0152-53404943 | karl-friedrich.kowalewski@umm.de | |
| Johannes Kilz | Contact | 0162-5297396 | johanneskilz@stud.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Karl-Friedrich Kowalewski, PD Dr. med | Department of Urology, University Medical Center Mannheim, Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, University Medical Center Mannheim, University of Heidelberg | Recruiting | Mannheim | Baden-Wurttemberg | 68167 | Germany |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D009043 | Motor Activity |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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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. |
| 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 | On postoperative day 30 and 90 |
| Operating time | In minutes, incision - surgical incision closure | On the day of surgery |
| Blod loss | In millilitres | On the day of surgery |
| Required transfusion of blood products | Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma | On the day of surgery |
| Feasibility of the planned urinary diversion | Yes or no | On the day of surgery |
| Conversion rate | If the planned urinary diversion is not feasible | 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) | 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 | 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 | On postoperative day 90 if occured |
| Reoperation rate | Reoperation due to a complication of the radical cystectomy | On postoperative day 90 if occured |
| Length of stay in the intensive care unit (ICU) | Days spent in the ICU after surgery | On postoperative day 90 if occured |
| Urologische Klinik München Planegg (UKMP) | Recruiting | München | Bavaria | Germany |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |