Alnes, Sigrid Ryeng
Lærum-Onsager, Ellisiv
Bye, Asta
Vistven, Annette
Franzén, Erika
Holst, Mette
Brovold, Therese
Funding for this research was provided by:
The Norwegian fund for post-graduate training in Physiotherapy (129800, 129800)
Article History
Received: 11 November 2022
Accepted: 21 February 2023
First Online: 2 March 2023
Declarations
:
: The project is approved by the Regional Comittees for Medical Research Ethics South/East Norway (REK South/East) (REC116419) and is registered at clinicalTrials.gov (NCT04945876). The study is designed in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and the SPIRIT reporting guidelines. All participants will provide written consent (improved by the REK South/East) prior to inclusion, participation is voluntary, and all participants is informed of their right to withdraw their consent at any time. All data is pseudonymised with an ID number and saved on the Services for Sensitive Data (TSD) platform. Participants are not financially compensated, except for travel expenses. No major adverse events are anticipated, any unforeseen adverse events will be documented.To compensate for the differential treatment of the groups, all participants in the usual care group will be offered a session of individual exercise and diet guidance completing their participation in the study. They will also be offered information on how the activity wristband is used and, if interested, is given the opportunity to try it themselves.
: Not applicable.
: The authors declare no competing interests.