Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416319
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-05
Brief Title:
Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy PreAct
Sponsor:
Universitätsmedizin Mannheim
Organization:
Universitätsmedizin Mannheim
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreAct
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 eg name tracker10 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 tracker10 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
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 eg name tracker10 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 tracker10 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None