SYNchronizing Exercises, Remedies in Gait and Cognition at Home (SYNERGIC@Home) — SYNERGIC@Hom  

Mild Cognitive Impairment Clinical Trial

Official title: SYNchronizing Exercises, Remedies in Gait and Cognition at Home: Feasibility of a Home-based Double-blind Randomized Controlled Trial to Improve Gait and Cognition in Individuals at Risk for Dementia

Status Completed

Clinical Trial Summary

Background: Prevention of Alzheimer's Disease and Related Dementias (ADRDs) may be possible for persons with subjective (SCI) or mild cognitive impairment (MCI), or normal cognition and risk factors. Physical exercise and cognitive training have been shown to enhance cognitive function and mobility in MCI when delivered in a research facility. The feasibility of delivering interventions in the home of older adults at risk for developing ADRDs is not known. What preferences the participants have for these interventions are also unknown. The primary goals are: 1) assess feasibility of a home-based delivery of exercise and cognitive interventions 2) evaluate the relationship between participants' intervention preferences and adherence. Secondary objectives focus on cognition, frailty, mobility, sleep, diet and mental health.

Methods and analysis: SYNERGIC@Home is a randomized control trial (using a 2 x 2 factorial design) with a 16-week home-based intervention program of physical exercises with cognitive training. Sixty-four participants will be randomized in blocks of four: 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. It will be implemented virtually through video conferencing. Baseline, 4- and 10-month post-intervention will include measures of cognition, frailty, mobility, sleep, diet, and psychological health. Feasibility outcomes include recruitment and retention. Preference will be used to determine the relationship between preference adherence. Secondary outcomes will evaluate the effect of the interventions on cognitive, mobility, and general well-being.

Clinical Trial Description

BACKGROUND: Nearly half a million Canadians live with Alzheimer's Disease and Related Dementias (ADRDs), and approximately one third of those cases could have been prevented with early intervention. Physical exercise and cognitive training are emerging interventions that have the potential to enhance cognitive function and mobility in older adults at risk for developing dementia. The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition), a large multi-site randomized control trial, showed promising preliminary data that individuals in an active exercise intervention combining aerobic exercise with progressive resistance training (AE+RT) and in a cognitive training program (NEUROPEAKTM) had better cognitive outcomes than a balance and toning control (BAT) intervention paired with a control cognitive intervention consisting of website searching and watching a simple video (WS+V). While these interventions were provided face to face in a research facility, little is known about the feasibility of delivering these multi-domain interventions at home in older adults at risk for developing ADRDs. Thus, the primary goal of the present trial-the SYNERGIC@Home trial-is to establish the feasibility of delivering a combined multimodal exercise and cognitive training intervention program for 16 weeks to 64 older adults at home using video-conferencing.

HYPOTHESIS: Based on the success of the SYNERGIC trial, we expect that SYNERGIC@Home will follow suit and yield high recruitment, retention, and adherence rates-particularly in light of the fact that SYNERGIC@Home eliminates any of the natural inconveniences of in person testing.

METHODS: SYNERGIC@Home is a randomized control trial (RCT) with a 16-week home-based intervention program of combined physical exercises with cognitive training. Sixty-four participants will be randomized to one of the following four arms: 1) combined exercise (AE+RT) + cognitive training (NEUROPEAKTM); 2) combined exercise (AE+RT) + control cognitive training (WS+V); 3) Control exercise (BAT) + cognitive training (NEUROPEAKTM) ; and 4) Control exercise (BAT) + control cognitive training (WS+V). SYNERGIC@Home will be implemented entirely virtually through video and phone conferencing. Baseline, immediate post-intervention follow-up, and 6-month post-intervention follow-up assessments will include measures of cognition, frailty, mobility, sleep, diet, and psychological health. For primary feasibility objectives, we will obtain measures of recruitment and retention rates. For primary analytic objectives, we will examine the distribution of preference ratings and determine if there is a relationship between preference for a given intervention and subsequent adherence. 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 both baseline and follow-up. If we find a relatively equal split in sex our sample, we will conduct gender-based analyses as additional, exploratory research.

EXPECTED RESULTS AND DISCUSSION: The SYNERGIC@Home trial will establish the feasibility of a combined multimodal intervention program delivered at home in older adults. Similarly, it will estimate the frequency and strength of participant preference for different interventions and delineate the relationship between intervention preference and subsequent adherence. It will also build capacity for and pilot the delivery of multi-domain interventions using an entirely home-based protocol with individuals at risk for ADRDs. The SYNERGIC@Home trial will inform future larger scale studies on the feasibility and success of implementing home-based interventions for individuals at risk for ADRDs. Insights gained from this feasibility trial will be instrumental in developing various other at home, remote, and virtual intervention programs for community-dwelling older adults. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT04997681
• Study type: Interventional
• Source: University of New Brunswick
• Status: Completed
• Phase: N/A
• Start date: July 28, 2021
• Completion date: July 27, 2023