Document is current
Any future updates will be listed below
-
Authors
-
Funding
Funding for this research was provided by:
Universitätsklinikum Tübingen
- License Information
-
More Information
Article History
Received: 3 April 2023
Accepted: 30 August 2023
First Online: 5 October 2023
Declarations
:
: The complete final trial dataset will only be assessed by employees of the University Hospital Tübingen. Any information provided in the context of the interaction with the digital application (technical queries, log files, information given within the scope of the software use) can be assessed by the app producer and the study sponsor. However, these data are pseudonymized and cannot be reidentified by any party other than the University Hospital.This study is approved by the Ethics Committee of the Medical Faculty of the University of Tübingen (688/2022BO2). The trial was registered on 20/01/2023 at (ID: DRKS00030932). Participants will be informed about the potential harms and benefits of the study and the voluntariness of study participation. Written informed consent will be obtained from all participants prior to study inclusion. In case of modifications of the protocol, an amendment will be sent to the local ethics committee prior to the implementation.
: The person in Fig. gave written informed consent for the image to be included in this manuscript.
: The exercise intervention that is implemented in the re.flex app was designed by employees of the University Hospital (i.e., VD, IK) in the context of a previous cooperation project between the trial sponsor Sporlastic GmbH and the University Hospital Tübingen. The pilot study of this trial protocol was conducted during this cooperation project as well. The University Hospital will be appropriately compensated for granting rights of use to the results generated by employees of the University Hospital (intellectual property) in the event of successful commercialization of the app. University Hospital will compensate the employees (i.e., VD, IK) who were involved in the previous collaboration and are authors of the intellectual property from these revenues. Contract negotiations are currently underway. However, the PI (PJ) of the study outlined in this study protocol and the biomedical statisticians (PM) do not have any conflicts of interest.
