,
Castell, M. V.
Gutiérrez-Misis, A.
Sánchez-Martínez, M.
Prieto, M. A.
Moreno, B.
Nuñez, S.
Triano, R.
de Antonio, M. P.
Mateo, C.
Cano, M. D.
Garrido, A.
Julian, R.
Polentinos, E.
Rodriguez-Barrientos, R.
Otero Puime, A.
Funding for this research was provided by:
Instituto de Salud Carlos III (PI 17/01887)
Article History
Received: 26 November 2018
Accepted: 28 December 2018
First Online: 28 January 2019
Ethics approval and consent to participate
: The trial respects the basic ethical principles of autonomy, beneficence, justice and doing no harm. Its implementation will follow the standards of Good Clinical Practice, the principles enunciated in the last Declaration of Helsinki (Fortaleza 2013), and the Oviedo Convention (1997).Written informed consent will be obtained from all participants prior to inclusion in the study. All the objectives, physical tests, and aspects related to the methodology and the intervention will be explained orally and in writing. Researcher’s commitment will be requested from each participating professional. Data confidentiality and anonymity will be guaranteed in all phases of the study following the 2009 law regulating personal data protection.The project has been approved by the Clinical Research Ethics Committee of the University Hospital La Paz in Madrid (HULP 5004) in March 2018.The project has been registered in ClinicalTrial in 26 June 2018 (code: NCT03568084). The provided trial registration number is not retrospectively registered. The date of enrollment of the first participant to the trial was July 2nd 2018.
: Not applicable.
: The authors declare that they no competing interests.
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