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Authors
van Westerhuis, C. https://orcid.org/0009-0002-4296-1777
de Leeuwerk, M. E. https://orcid.org/0000-0003-3849-2605
van der Werf, E. W. J.
Kruizenga, H. M. https://orcid.org/0000-0001-9250-6970
de Groot, V. https://orcid.org/0000-0002-6073-6250
Geleijn, E. https://orcid.org/0000-0003-1521-6456
der Leeden, M. van https://orcid.org/0000-0001-6465-0983
van der Schaaf, M. https://orcid.org/0000-0001-7272-4698
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Funding
Funding for this research was provided by:
Nationaal Regieorgaan Praktijkgericht Onderzoek SIA (Grant SBV/ RAAK.PUB09.039)
Amsterdam Movement Sciences Institute
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Article History
Received: 9 January 2025
Accepted: 6 June 2025
First Online: 19 June 2025
Declarations
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: The trial protocol has been approved by the Medical Ethical Research Committee (METC) of Amsterdam UMC, location VUmc (METC 2021.0627). This study will be conducted according to the principles of the Declaration of Helsinki (version October 2013), in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and the Dutch Personal Data Protection Act (General Data Protection Regulation (GDPR)). The trial has been registered at the International Clinical Trials Registry Platform (NL9793) and the study description is available at the following web link: . All amendments of the protocol will be notified to the METC and the competent authority. Non-substantial amendments will not be notified to the accredited METC and the competent authority but will be recorded and filed by the sponsor. Participating sites in the study will be notified of any changes to the study protocols. This will enable them to make the necessary arrangements to incorporate the changes, if necessary, and to confirm their continued support for the study after the implementation of the changes. All patients will sign informed consent prior to participation in the trial. All participants will be informed that they are under no obligation to enter the trial and that they can withdraw at any time during the trial without having to give a reason and that this will not affect the medical care they receive.
: This study was part of the OPRAH trial, which has been approved by the Medical Ethical Research Committee (METC) of Amsterdam UMC, location VUmc (METC 2021.0627). This trial was conducted according to the principles of the Declaration of Helsinki (version 9, October 2013), in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and the Dutch Personal Data Protection Act (General Data Protection Regulation (GDPR)). The trial has been registered at the International Clinical Trials Registry Platform (NL9793) and the study description is available at the following web link: . All patients signed informed consent prior to participation in the trial and additionally before interviews. All participants were informed that they are under no obligation to enter the trial and that they can withdraw at any time during the trial without having to give a reason and that this will not affect the medical care they receive.
: Not applicable.
: The authors declare no competing interests.
