Fauser, David http://orcid.org/0000-0002-3845-3094
Dötsch, Saskia
Langer, Claudia
Kleineke, Vera
Kindel, Claudia
Bethge, Matthias http://orcid.org/0000-0002-6417-7812
Funding for this research was provided by:
Bundesministerium für Arbeit und Soziales (661S0183X1)
Universität zu Lübeck
Article History
Received: 10 August 2022
Accepted: 31 August 2022
First Online: 9 September 2022
Declarations
:
: The investigation conforms to the principles outlined in the Declaration of Helsinki. The study protocol was approved by the Ethics Committee of the University of Lübeck (21–503), and participation in the study is voluntary. Eligible participants will receive written information about the study aims, participation, and their right to refuse participation. Model consent and information forms are available as Additional Files InternalRef removed and InternalRef removed. The study has been registered on the German Clinical Trials Register (DRKS00027577). The items from the World Health Organization Trial Registration Data Set are available as Additional File InternalRef removed. This paper contains the original study protocol. Any substantial modifications to the study protocol will be transmitted to the Ethics Committee of the University of Lübeck for approval prior to implementation. These amendments will be documented in detail in the German Clinical Trials Register, and will be described transparently in trial reports.
: This manuscript does not contain any individual person’s data; hence, no consent for publication is needed.
: SD, CL and CK are study coordinators in the three rehabilitation centers. VK is from the German Pension Insurance North, which requested funding for the project from the Federal Ministry of Labour and Social Affairs. The remaining authors declare that they have no competing interests.