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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.
BMJ Open. 2022 03 31; 12(3):e059988.BO

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.

Authors+Show Affiliations

Faculty of Kinesiology, University of New Brunswick Fredericton, Fredericton, New Brunswick, Canada cmcgibb@unb.ca. Institute of Biomedical Engineering, University of New Brunswick, Fredericton, New Brunswick, Canada.Department of Geriatric Medicine, Horizon Health Network, Saint John, New Brunswick, Canada. Faculty of Medicine, Deptartment of Internal Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.Faculty of Health Sciences and Community Services, School of Kinesiology and Recreation, Universite de Moncton, Moncton, New Brunswick, Canada.Faculty of Kinesiology, University of New Brunswick Fredericton, Fredericton, New Brunswick, Canada.Faculty of Health Sciences and Community Services, School of Food Science, Nutrition and Family Studies, Universite de Moncton, Moncton, New Brunswick, Canada.Institute of Biomedical Engineering, University of New Brunswick, Fredericton, New Brunswick, Canada.Research Services, Horizon Health Network, Saint John, New Brunswick, Canada.Research Services, Horizon Health Network, Saint John, New Brunswick, Canada.Research Services, Vitalite Health Network, Moncton, New Brunswick, Canada.Department of Neuroscience, Dr Georges-L-Dumont University Hospital Centre, Moncton, New Brunswick, Canada.Department of Physical Therapy, The University of British Columbia, Vancouver, British Columbia, Canada.Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.Faculty of Science, Department of Kinesiology and Physical Education, Wilfrid Laurier University, Waterloo, Ontario, Canada.Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.Neurology Division, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada.Gait and Brain Laboratory, Lawson Health Research Institute, London, Ontario, Canada.Gait and Brain Laboratory, Lawson Health Research Institute, London, Ontario, Canada. Department of Medicine (Geriatrics), Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

35361653

Citation

McGibbon, Chris, et al. "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." BMJ Open, vol. 12, no. 3, 2022, pp. e059988.
McGibbon C, Jarrett P, Handrigan G, et al. 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. BMJ Open. 2022;12(3):e059988.
McGibbon, C., Jarrett, P., Handrigan, G., Bouchard, D., Tranchant, C. C., Sexton, A. M., Yetman, L., Robinson, B., Crapoulet, S., Chamard-Witkowski, L., Liu-Ambrose, T., Middleton, L. E., Almeida, Q. J., Bherer, L., Lim, A., Speechley, M., Kamkar, N., & Montero Odasso, M. (2022). 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. BMJ Open, 12(3), e059988. https://doi.org/10.1136/bmjopen-2021-059988
McGibbon C, et al. 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. BMJ Open. 2022 03 31;12(3):e059988. PubMed PMID: 35361653.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - McGibbon,Chris, AU - Jarrett,Pam, AU - Handrigan,Grant, AU - Bouchard,Danielle, AU - Tranchant,Carole C, AU - Sexton,Andrew M, AU - Yetman,Linda, AU - Robinson,Bryn, AU - Crapoulet,Stephanie, AU - Chamard-Witkowski,Ludivine, AU - Liu-Ambrose,Teresa, AU - Middleton,Laura Elizabeth, AU - Almeida,Quincy J, AU - Bherer,Louis, AU - Lim,Andrew, AU - Speechley,Mark, AU - Kamkar,Nellie, AU - Montero Odasso,Manuel, AU - ,, Y1 - 2022/03/31/ PY - 2022/4/1/entrez PY - 2022/4/2/pubmed PY - 2022/4/5/medline KW - Dementia KW - GERIATRIC MEDICINE KW - Neuropathology KW - Physiology SP - e059988 EP - e059988 JF - BMJ open JO - BMJ Open VL - 12 IS - 3 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/35361653/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_ DB - PRIME DP - Unbound Medicine ER -