Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2026-03-14

Brief Summary

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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.

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Detailed Description

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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".

Conditions

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Bladder Cancer Bladder Neoplasm Bladder Urothelial Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daily Activity Goal and Feedback

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.

Group Type EXPERIMENTAL

Daily Activity Goal and Feedback

Intervention Type 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.

No Daily Activity Goal or Feedback

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Daily 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No