Study design
MAY
The study design was a 2-group randomized controlled trial with pre-, post-intervention and one-month follow-up measurements. The allocation ratio was 1:1. The study was performed at University of Zaragoza from October 2015 to May 2018. A researcher not involved in the study randomized the intervention groups using a computer software (The study was conducted following the Declaration of Helsinki and the approval of the Clinical Research Ethics Committee of the Community of Aragon (CEICA), Spain (CEICA number: PI15/229) was obtained. All participants provided informed consent before their enrolment in the study. This clinical trial was carried out in the Faculty of Health Sciences facilities, University of Zaragoza, Spain; the center itself has a risk prevention model that could be activated if necessary. The participants remained in contact with their general practitioners and neurologists during the study to be able to report any incidents. (clinicaltrials.gov number: NCT03056131). This study followed the CONSORT criteria.