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SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.

Department of Medicine, Division of Geriatric Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada. mmontero@uwo.ca. Department of Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada. mmontero@uwo.ca. Gait and Brain Lab, Parkwood Institute, Lawson Health Research Institute, London, Canada. mmontero@uwo.ca. Sun Life Financial Movement Disorders Research Centre, Wilfrid Laurier University, Waterloo, Canada. Schulich School of Medicine and Dentistry, University of Western Ontario, London, Canada. Geriatric and Cognitive Neurology, University of Alberta, Edmonton, Canada. Functional Neuroimaging Unit, University of Montreal, Montreal, Canada. Department of Psychology-University of Ottawa, Ottawa, Canada. Department of Psychology and PERFORM Centre, Concordia University, Montreal, Canada. Department of Physical Therapy, University of British Columbia, Centre for Hip Health and Mobility, and Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Research Institute, University of British Columbia, Vancouver, Canada. Department of Kinesiology, University of Waterloo, Waterloo, Canada. School of Physical Therapy, University of Western Ontario, London, Canada. Division of Neurology and Department of Medicine, University of Toronto. Tanz Centre for Research in Neurodegenerative Diseases, University of Toronto, Toronto, Canada. Division of Geriatrics and Centre of Excellence in Aging and Chronic Disease, McGill University, Montreal, Canada. Department of Medicine, Division of Geriatric Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada. Gait and Brain Lab, Parkwood Institute, Lawson Health Research Institute, London, Canada. Department of Kinesiology, University of Western Ontario, London, Canada. Department of Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada. Department of Psychiatry, Division of Geriatric Psychiatry and Department of Medicine, Division of Clinical Pharmacology, University of Western Ontario, London, Canada. Robarts Clinical Trials Inc, London, Canada. Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada. Department of Sports Studies, Bishop's University, Sherbrooke, Canada. Faculty of Medicine, University of Montreal, Montréal, Canada. St. Joseph's Health Care, London, Canada. Montreal Heart Institute, Research Centre, Montreal, Canada.

BMC geriatrics. 2018;(1):93
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Abstract

BACKGROUND Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. METHODS The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. DISCUSSION The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. TRIAL REGISTRATION Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .

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