Study design and procedure
RECRUITMENT
A stepped-wedge research design was adopted, randomly assigning patients to two groups that differed for training and assessment timing. Randomization of patient assignment was conducted according to a coin flip procedure by means of the randomization tool of Microsoft Excel: a random number was randomly associated to each patient and determined the allocation to either the Training-first group (0 to 0.49) or the Waiting-first group (0.5 to 1). Both participant enrollment and randomization were conducted by a researcher who was not part of the research team involved in testing participants. The Training-first group underwent the baseline assessment at T1 and then started the training; at T2, after training conclusion, it received the post-training evaluation; at T3 it received the 2-month follow-up evaluation. The Waiting-first group underwent the baseline assessment at T1, before starting a waiting-list period; at T2 it received the pre-training assessment and then started the training; at T3, after the completion of the training, it underwent the post-training assessment. Finally, a follow-up assessment was conducted after 6-month from T3 for both the Training-first group (T4) and the Waiting-first group (T5).The research team was not blinded to participants’ treatment allocation, as a report containing all training information for each participant was received weekly from Lumos Lab to monitor training adherence. However, outcome assessors and participants were blinded with respect to condition assignment.The software G Power 3 was used to estimate the sample sizeAll procedures used for this study are in accordance with the 1964 Helsinki declaration and its later amendments and comparable ethical standards. All data were collected at Scientific Institute, IRCCS E. Medea, Bosisio Parini, Italy. This study was conducted in accordance with CONSORT guidelines for non-pharmacological interventionsThe study was registered with the ISRCTN registry, as study ID ISRCTN59250807 (The study was approved by the Ethic Committee of Scientific Institute, IRCCS E. Medea, Bosisio Parini, Italy (project number 284 on 01/03/2016, subsequently amended by project number 337 on 12/07/2016). Recruitment for this study started on 02/03/2016 and ended on 27/11/2019. The whole trial ended on 27/09/2020.