2.1. Study Design, Setting, and Participants
This was a monocentric study that employed a prospective randomized controlled clinical trial design with two groups—an experimental group (EG) and a control group (CG). The observer was blinded. The study protocol, including details of randomization and intervention, as well as the statistical analysis plan, was registered at Assessments were performed at baseline (T0), 6 months (T1), and 12 months (T2), the first patient was enrolled on 29 April 2013, and the last end-of-trial consultation was conducted on 17 January 2018. Each patient participated in the study for 12 months, and the total duration of the research was 4 years, 8 months, and 18 days.All subjects who met the eligibility criteria provided written informed consent in accordance with the study protocol. Using a secure internet connection, participants were randomly allocated (in blocks of variable size) to either an EG that received regular personalized coaching on PA or a CG that received standard care. The randomization process was guaranteed through an individual user ID and password, as well as encrypted data transmission to the randomization platform of the Clinical Research Unit of the Limoges University Hospital.