ABSTRACT
INTRODUCTION: Physical exercise and cognitive training have the potential to enhance cognitive function and mobility in older adults at risk of Alzheimer's disease and related dementia (ADRD), but little is known about the feasibility of delivering multidomain interventions in home settings of older adults at risk of ADRD. This study aims to assess the feasibility of home-based delivery of exercise and cognitive interventions, and to evaluate the relationship between participants' intervention preferences and their subsequent adherence. Secondary objectives include the effect of the interventions on ADRD risk factors, including frailty, mobility, sleep, diet and psychological health. METHODS AND ANALYSIS: The SYNchronising Exercises, Remedies in GaIt and Cognition at Home (SYNERGIC@Home) feasibility trial is a randomised control trial that follows a 2×2 factorial design, with a 16-week home-based intervention programme (3 sessions per week) of physical exercises and cognitive training. Participants will be randomised in blocks of four to one of the following four arms: (1) combined exercise (aerobic and resistance)+cognitive training (NEUROPEAK); (2) combined exercise+control cognitive training (web searching); (3) control exercise (balance and toning)+cognitive training; and (4) control exercise+control cognitive training. SYNERGIC@Home will be implemented through video conferencing. Baseline and post-intervention assessments at 4-month and 10-month follow-up will include measures of cognition, frailty, mobility, sleep, diet and psychological health. Primary feasibility outcome is adherence to the interventions. Primary analytic outcome is the relationship between pre-allocation preference for a given intervention and subsequent adherence to the allocated intervention. A series of secondary analytic outcomes examining the potential effect of the individual and combined interventions on cognitive, mobility and general well-being will be measured at baseline and follow-up. ETHICS AND DISSEMINATION: Ethics approval was granted by the relevant research ethics boards. Findings of the study will be presented to stakeholders and published in peer-reviewed journals and at provincial, national and international conferences. TRIAL REGISTRATION NUMBER: NCT04997681, Pre-results.
Subject(s)
Alzheimer Disease , Cognition , Aged , Double-Blind Method , Exercise , Feasibility Studies , Gait , Humans , Randomized Controlled Trials as TopicABSTRACT
Synergic@Home is a feasibility study evaluating the effects of exercise and cognitive interventions for the prevention of dementia in at-risk individuals over age 60. The COVID-19 pandemic changed the study’s methods, with standardized neuropsychological tests needing to be administered virtually. Experience and research into the viability of neuropsychological assessments administered virtually is limited. After receiving permission to adapt the tests for virtual administration, a neuropsychologist, project managers, and research coordinators developed their approach. A PowerPoint presentation using text and visual stimuli from the tests was developed with on-screen instructions for the raters. An iterative development process involved feedback from the team in order to maximize the fidelity of these methods compared to in-person administration. Mock assessments supervised by a neuropsychologist further refined the methods and confirmed rater adherence to standardized procedures. A secure videoconferencing platform meeting privacy requirements was used. Dual monitors for the raters provided instructions on one monitor while stimuli for the participant was on the second monitor. The participant could only see the stimuli. This method of administering neuropsychological assessment, the Feasibility of Research with Online Neuropsychological Testing (FRONT), is being used to evaluate older adult participants in Synergic@Home. Results from this feasibility study may set the stage for new research methodologies and/or clinical evaluations in the future. This project is funded by the New Brunswick Healthy Seniors Pilot Project and the Canadian Consortium on Neurodegeneration in Aging (with grants from Public Health Agency of Canada and the Canadian Institutes of Health Research, with additional funding partners).