SYNchronizing Exercises, Remedies in Gait and Cognition at Home (SYNERGIC@Home)
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Combined Aerobic Exercise and Resistance Training (AE + RT); Cognitive Training (NeuropeakTM); Control Cognitive Training of Website Searching and Video Watching (WS+V); Control Balance and Toning Exercise Training (BAT)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): AE + RT will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. AE + RT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 strength training exercises (that progressively increase in resistance intensity over time) will be completed followed by a break. Aerobic exercises that safely increase the participant's heart rate will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the AE + RT exercise session is approximately 65 minutes.; NeuropeakTM is a program which will be completed by participants remotely using a tablet or computer. It consists of cognitive training including dual-task training that requires participants to maintain and prepare for many response alternatives (working memory) and to share attention between two concurrent tasks (divided attention). Difficulty of cognitive training is tailored to their individual functioning level. During each session, participants perform one of two different visuo-motor tasks, which include sets of visual stimuli (e.g., letters, numbers, animals, vehicles, fruits, celestial bodies) and respective hand-button correspondences (i.e., keys that are to be tapped on either the right or the left side of the screen). Participants are instructed to perform these tasks as fast as possible, while maintaining accuracy. Training also includes online feedback and a histogram of daily performance to encourage improvement. NeuropeakTM takes approximately 30 minutes to complete.; During the WS + V task, participants alternate between 2 different tasks (touristic searching using internet and video watching). For the touristic searching using internet, participants are required to find 3 hotels, 3 touristic places, and 3 restaurants of their own preference in a city assigned by the instructor (a new city will be selected each session). They will also need to include the respective addresses of those places on their log sheet. For the video watching task, participants watch a National Geographic video on YouTube selected by the instructor with a different video selected for each session. They will watch the video for 20 minutes and during the remaining 5 minutes they will answer the following questions on their log sheet: 1) What is the video about? 2) What is the most important information in your opinion? 3) Create a question based on the video and answer your own question. WS + V sessions take approximately 30 minutes to complete.; BAT exercises will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. BAT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 balance and toning exercises will be completed followed by a break. Stretching exercises will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the BAT exercise session is approximately 65 minutes.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2x2 factorial design
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise; Cognitive training; Intervention preference; Elderly; Gait; Dementia; Home-based intervention; Cognitive impairment