Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma
Conditions
Keywords
Cystectomy, Preoperative Exercise, Fitness Trackers, Exercise, Frailty
Brief 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.
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.
Interventions
DEVICEDaily Activity Goal and Feedback
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.
Sponsors
Dr. Rolf M. Schwiete Foundation
Universitätsmedizin Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of steps per day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative physical activity | Morning of postoperative day 4 at 7 PM | 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. |
| Postoperative Complications | On postoperative day 30 and 90 | 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 |
| Operating time | On the day of surgery | In minutes, incision - surgical incision closure |
| Blod loss | On the day of surgery | In millilitres |
| Required transfusion of blood products | On the day of surgery | Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma |
| Feasibility of the planned urinary diversion | On the day of surgery | Yes or no |
| Total number of steps | Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down. | Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery. |
| Patient Reported Outcome Measures (PROMs) | 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 | 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) |
| Length of hospital stay (LOS) | On the day of discharge which is on average 2 weeks after the surgery | LOS measured by the number of days spent in the hospital after surgery until discharge |
| Readmission rate | On postoperative day 90 if occured | Readmissions due to a complication of the radical cystectomy |
| Reoperation rate | On postoperative day 90 if occured | Reoperation due to a complication of the radical cystectomy |
| Length of stay in the intensive care unit (ICU) | On postoperative day 90 if occured | Days spent in the ICU after surgery |
| Conversion rate | On the day of surgery | If the planned urinary diversion is not feasible |
Countries
Germany
Contacts
Primary ContactKarl-Friedrich Kowalewski, PD Dr. med.
Backup ContactJohannes Kilz
Outcome results
None listed