The Brain in Motion II Study: study protocol for a randomized controlled trial of an aerobic exercise intervention for older adults at increased risk of dementia

Trials

Todd J. Anderson¹  Fiona Clement²  Heather M. Hanson³  Jean M. Rawling⁴  Cameron M. Clark⁵  Adrienna M. Dyck⁶  Renata L. Krüger⁶  Marc J. Poulin⁷  G. Bruce Pike⁸  Michael D. Hill⁹  Tolulope Sajobi^1,10  Jayna Holroyd-Leduc^1,11  David B. Hogan^1,11  R. Stewart Longman^1,12  Patrick J. Hanly^1,12  Meghan McDonough^1,13 

[1] Department of Cardiac Sciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Libin Cardiovascular Institute of Alberta, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Community Health Sciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Community Health Sciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Seniors Health Strategic Clinical Network™, Alberta Health Services, Edmonton, Alberta, Canada;Department of Family Medicine at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Physiology & Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, T2N 4N1, Canada, Calgary, Alberta, Canada;Department of Physiology & Pharmacology, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Physiology & Pharmacology, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Libin Cardiovascular Institute of Alberta, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Clinical Neurosciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Faculty of Kinesiology, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Brenda Strafford Foundation Chair in Alzheimer Research, Calgary, Alberta, Canada;Heritage Medical Research Building, Room 210, 3330 Hospital Drive NW, T2N 4N1, Calgary, Alberta, Canada;Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Clinical Neurosciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Radiology at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;CAIP Chair in Healthy Brain Aging, Calgary, Canada;Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Community Health Sciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Clinical Neurosciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Medicine at the University of Calgary, T2N 4 N1, Calgary, Alberta, Canada;Department of Radiology at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Community Health Sciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Department of Community Health Sciences at the University of Calgary, T2N 4N1, Calgary, Alberta, Canada;O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Seniors Health Strategic Clinical Network™, Alberta Health Services, Edmonton, Alberta, Canada;Department of Medicine at the University of Calgary, T2N 4 N1, Calgary, Alberta, Canada;Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Sleep Centre, Foothills Medical Centre, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;Faculty of Kinesiology, University of Calgary, T2N 4N1, Calgary, Alberta, Canada;

关键词: Alzheimer’s disease;    Behavioural support;    Brain health;    Cognitive function;    Dementia;    Physical activity;    Sleep quality;   

DOI  :  10.1186/s13063-021-05336-z

来源: Springer

【 摘 要 】

BackgroundThere remains no effective intervention capable of reversing most cases of dementia. Current research is focused on prevention by addressing risk factors that are shared between cardiovascular disease and dementia (e.g., hypertension) before the cognitive, functional, and behavioural symptoms of dementia manifest. A promising preventive treatment is exercise. This study describes the methods of a randomized controlled trial (RCT) that assesses the effects of aerobic exercise and behavioural support interventions in older adults at increased risk of dementia due to genetic and/or cardiovascular risk factors. The specific aims are to determine the effect of aerobic exercise on cognitive performance, explore the biological mechanisms that influence cognitive performance after exercise training, and determine if changes in cerebrovascular physiology and function persist 1 year after a 6-month aerobic exercise intervention followed by a 1-year behavioural support programme (at 18 months).MethodsWe will recruit 264 participants (aged 50–80 years) at elevated risk of dementia. Participants will be randomly allocated into one of four treatment arms: (1) aerobic exercise and health behaviour support, (2) aerobic exercise and no health behaviour support, (3) stretching-toning and health behaviour support, and (4) stretching-toning and no health behaviour support. The aerobic exercise intervention will consist of three supervised walking/jogging sessions per week for 6 months, whereas the stretching-toning control intervention will consist of three supervised stretching-toning sessions per week also for 6 months. Following the exercise interventions, participants will receive either 1 year of ongoing telephone behavioural support or no telephone support. The primary aim is to determine the independent effect of aerobic exercise on a cognitive composite score in participants allocated to this intervention compared to participants allocated to the stretching-toning group. The secondary aims are to examine the effects of aerobic exercise on a number of secondary outcomes and determine whether aerobic exercise-related changes persist after a 1-year behavioural support programme (at 18 months).DiscussionThis study will address knowledge gaps regarding the underlying mechanisms of the pro-cognitive effects of exercise by examining the potential mediating factors, including cerebrovascular/physiological, neuroimaging, sleep, and genetic factors that will provide novel biologic evidence on how aerobic exercise can prevent declines in cognition with ageing.Trial registrationClinicalTrials.gov NCT03035851. Registered on 30 January 2017

【 授权许可】

CC BY