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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.

ABSTRACT: Background: 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. Methods: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. Discussion: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. Ethics and Dissemination:The study is approved by the Local Ethics Committee and registered in https://clinicaltrials.gov (NCT03383549). Dissemination will include submission to a peer-reviewed journal, patients, and healthcare magazines and congress presentations. Trial Registration: ClinicalTrials.gov ID: NCT03383549 (registration date: 26/dec/2017) Trial Funding: Bando FAS Salute 2014 Regione Toscana Version Identifier: ver 5-16/11/2018.

SUBMITTER: Fabbri L

PROVIDER: S-EPMC6336896 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Project description:BackgroundMild cognitive impairment (MCI) increases the risk of dementia. The efficacy of cognitive training in patients with MCI is unclear.MethodsIn a two-site, single-blinded, 78-week trial, participants with MCI - stratified by age, severity (early/late MCI), and site - were randomly assigned to 12 weeks of intensive, home-based, computerized training with Web-based cognitive games or Web-based crossword puzzles, followed by six booster sessions. In mixed-model analyses, the primary outcome was change from baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) score, a 70 point scale in which higher scores indicate greater cognitive impairment at 78 weeks, adjusted for baseline. Secondary outcomes included change from baseline in neuropsychological composite score, University of California San Diego Performance-Based Skills Assessment (functional outcome) score, and Functional Activities Questionnaire (functional outcome) score at 78 weeks, adjusted for baseline. Changes in hippocampal volume and cortical thickness on magnetic resonance imaging were assessed.ResultsAmong 107 participants (n=51 [games]; n=56 [crosswords]), ADAS-Cog score worsened slightly for games and improved for crosswords at week 78 (least squares [LS] means difference, -1.44; 95% confidence interval [CI], -2.83 to -0.06; P=0.04). From baseline to week 78, mean ADAS-Cog score worsened for games (9.53 to 9.93) and improved for crosswords (9.59 to 8.61). The late MCI subgroup showed similar results (LS means difference, -2.45; SE, 0.89; 95% CI, -4.21 to -0.70). Among secondary outcomes, the Functional Activities Questionnaire score worsened more with games than with crosswords at week 78 (LS means difference, -1.08; 95% CI, -1.97 to -0.18). Other secondary outcomes showed no differences. Decreases in hippocampal volume and cortical thickness were greater for games than for crosswords (LS means difference, 34.07; SE, 17.12; 95% CI, 0.51 to 67.63 [hippocampal volume]; LS means difference, 0.02; SE, 0.01; 95% CI, 0.00 to 0.04 [cortical thickness]).ConclusionsHome-based computerized training with crosswords demonstrated superior efficacy to games for the primary outcome of baseline-adjusted change in ADAS-Cog score over 78 weeks. (Supported by the National Institutes of Health, National Institute on Aging; ClinicalTrials.gov number, NCT03205709.).

Project description:BackgroundTherapeutic virtual reality (VR) has emerged as an effective treatment modality for cognitive and physical training in people with mild cognitive impairment (MCI). However, to replace existing nonpharmaceutical treatment training protocols, VR platforms need significant improvement if they are to appeal to older people with symptoms of cognitive decline and meet their specific needs.ObjectiveThis study aims to design and test the acceptability, usability, and tolerability of an immersive VR platform that allows older people with MCI symptoms to simultaneously practice physical and cognitive skills on a dual task.MethodsOn the basis of interviews with 20 older people with MCI symptoms (15 females; mean age 76.25, SD 5.03 years) and inputs from their health care providers (formative study VR1), an interdisciplinary group of experts developed a VR system called VRADA (VR Exercise App for Dementia and Alzheimer's Patients). Using an identical training protocol, the VRADA system was first tested with a group of 30 university students (16 females; mean age 20.86, SD 1.17 years) and then with 27 older people (19 females; mean age 73.22, SD 9.26 years) who had been diagnosed with MCI (feasibility studies VR2a and VR2b). Those in the latter group attended two Hellenic Association Day Care Centers for Alzheimer's Disease and Related Disorders. Participants in both groups were asked to perform a dual task training protocol that combined physical and cognitive exercises in two different training conditions. In condition A, participants performed a cycling task in a lab environment while being asked by the researcher to perform oral math calculations (single-digit additions and subtractions). In condition B, participants performed a cycling task in the virtual environment while performing calculations that appeared within the VR app. Participants in both groups were assessed in the same way; this included questionnaires and semistructured interviews immediately after the experiment to capture perceptions of acceptability, usability, and tolerability, and to determine which of the two training conditions each participant preferred.ResultsParticipants in both groups showed a significant preference for the VR condition (students: mean 0.66, SD 0.41, t29=8.74, P<.001; patients with MCI: mean 0.72, SD 0.51, t26=7.36, P<.001), as well as high acceptance scores for intended future use, attitude toward VR training, and enjoyment. System usability scale scores (82.66 for the students and 77.96 for the older group) were well above the acceptability threshold (75/100). The perceived adverse effects were minimal, indicating a satisfactory tolerability.ConclusionsThe findings suggest that VRADA is an acceptable, usable, and tolerable system for physical and cognitive training of older people with MCI and university students. Randomized controlled trial studies are needed to assess the efﬁcacy of VRADA as a tool to promote physical and cognitive health in patients with MCI.

Dataset Information

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.

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