Protocol for SYNchronising Exercises, Remedies in GaIt and Cognition at Home (SYNERGIC@Home): feasibility of a home-based double-blind randomised controlled trial to improve gait and cognition in individuals at risk for dementia

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.

Keywords: Dementia; GERIATRIC MEDICINE; Neuropathology; Physiology.

Figure 1

Design of the SYNERGIC@Home feasibility trial. *Using ActiGraph GT9X. AE, aerobic exercise; BAT, balance and toning; CFC2, Cognitive Functional Composite 2; PHS, Polygenic Hazard Score; RT, resistance training; SYNERGIC@Home, SYNchronising Exercises, Remedies in GaIt and Cognition at Home; T0, baseline; T4, 4-month follow-up; T10, 10-month follow-up; WS+V, web searching and watching videos.

Figure 2

SPIRIT schedule of enrolment, interventions and assessments. Time points are: −t₂=4 weeks prior to allocation; −t₁=2 weeks prior to allocation; t₀=baseline testing and allocation (T0); t₁=first week of interventions; t₂=last week of interventions; t₃=4-month follow-up assessment (T4); t₄=2 weeks prior to 10-month follow-up; t₅=10-month follow-up assessment (T10). Interventions are 3× per week for 16 weeks (t₁−t₂). ^aPre-screening at –t₂ consists of exclusion screening and inclusion screening not requiring assessment, such as clinical dementia status and risk. ^bFinal screening at –t₁ consist cognitive battery #1, diet, sleep and functional risk factors used to designate participants as not demented but having MCI, SCI or CI with 2 or more risk factors. ^cCognitive battery #1 (–t₁, t₃ and t₅) consists of: TCogS; full MoCA via audio–visual conference; Lawton-Brody IADL; CFC-2 consisting of ADAS-Cog 3 immediate word recall, delayed word recall, and orientation, Logical Memory I and II; CDR Scale and Cognitive Functional Activities Questionnaire. ^dCognitive battery #2 (t₀, t₃ and t₅) consists of: Oral Trail Making Test (Parts A and B); Boston Naming Test; ADAS-Cog Word Recognition; DKEFS Phonemic Fluency Test and Semantic Fluency Test; Wechsler Adult Intelligence Scale (WAIS) III Digit Span Test; Digit Symbol Modalities Test–Oral Version. ^eSleep and activity monitoring for 10 days prior to assessment time points (−t₁−t₀, t₂–t₃ and t₄–t₅) using wrist worn actigraph (GT9X) monitor. ^fDual task gait battery (–t₁, t₃ and t₅) consists of: usual gait, seated dual task and dual task gait counting backwards by ones, naming animals and counting backwards by sevens. ^gExit survey completed at the end of study or on early withdrawal when possible. ^hPHS biomarkers assessed via saliva sample at any time point during study. ADAS-Cog, Alzheimer’s Disease Assessment Scale-Cognitive; AE, aerobic exercise; BAT, balance and toning; CDR, Clinical Dementia Rating; CFC2, Cognitive Functional Composite 2; CI, cognitively intact; DKEFS, Delis-Kaplan Executive Function System; IADL, Instrumental Activities of Daily Living; MCI, mild cognitive impairment; MoCA, Montreal Cognitive Assessment; PHS, Polygenic Hazard Score; RT, resistance training; SCI, subjective cognitive impairment; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; SYNERGIC@Home, SYNchronising Exercises, Remedies in GaIt and Cognition at Home; T0, baseline; T4, 4-month follow-up; T10, 10-month follow-up; TCogS, telephone cognitive screen; WS+V, web searching and watching videos.