AUTHOR=Fabbri Laura , Mosca Irene Eleonora , Gerli Filippo , Martini Leonardo , Pancani Silvia , Lucidi Giulia , Savazzi Federica , Baglio Francesca , Vannetti Federica , Macchi Claudio ,  The GOAL Working Group , Sorbi Sandro , Ferrari Camilla , Lombardi Gemma , Stoppini Andrea , Pazzi Stefania , Migliazza Tommaso 

TITLE=The Games for Older Adults Active Life (GOAL) Project for People With Mild Cognitive Impairment and Vascular Cognitive Impairment: A Study Protocol for a Randomized Controlled Trial

JOURNAL=Frontiers in Neurology

VOLUME=9

YEAR=2019

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2018.01040

DOI=10.3389/fneur.2018.01040

ISSN=1664-2295

ABSTRACT=<p><bold>Background:</bold> People living with Mild Cognitive Impairment (MCI) and Vascular Cognitive Impairment (VCI) are persons who do not fulfill a diagnosis of dementia, but who have a high risk of progressing to a dementia disorder. The most recent guidelines to counteract cognitive decline in MCI/VCI subjects suggest a multidimensional and multi-domain interventions combining cognitive, physical, and social activities. The purpose of this study is to test an innovative service that provides a multi-dimensional tele-rehabilitation program through a user-friendly web application. The latter has been developed through a participatory design involving MCI specialists, patients, and their caregivers. Particularly, the proposed tele-rehabilitation program includes cognitive, physical, and caregiver-supported social activities. The goal is to promote and preserve an active life style and counteract cognitive decline in people living with MCI/VCI.</p><p><bold>Methods:</bold>The study is a randomized controlled trial. Sixty subjects will be randomly assigned to the experimental group, who will receive the tele-rehabilitation program, or the control group, who will not receive any treatment. The trial protocol comprises three steps of assessment for the experimental group: at the baseline (T_0), after tele-rehabilitation program (T_1) and at follow-up after 12-months (T_2). Differently, the control group will be assessed twice: at the baseline and at 12-months follow-up. Both the experimental and the control group will be assessed with a multidimensional evaluation battery, including cognitive functioning, behavioral, functional, and quality of life measures. The tele-rehabilitation program lasts 8 weeks and includes cognitive exercises 3 days a week, physical activities 2 days a week, and social activities once a week. In addition, group will be given an actigraph (GENEActiv, Activisinghts Ltd., Cambridgshire, UK) to track physical and sleep activity.</p><p><bold>Discussion:</bold>Results of this study will inform on the efficacy of the proposed tele-rehabilitation to prevent or delay further cognitive decline in MCI/VCI subjects. The expected outcome is to counteract cognitive decline and improve both physical functioning and quality of life.</p><p><bold>Ethics and Dissemination:</bold>The study is approved by the Local Ethics Committee and registered in <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov</ext-link> (NCT03383549). Dissemination will include submission to a peer-reviewed journal, patients, and healthcare magazines and congress presentations.</p><p><bold>Trial Registration:</bold> ClinicalTrials.gov ID: NCT03383549 (registration date: 26/dec/2017)</p><p><bold>Trial Funding:</bold> Bando FAS Salute 2014 Regione Toscana</p><p><bold>Version Identifier:</bold> ver 5—16/11/2018</p>