Tags

Type your tag names separated by a space and hit enter

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. 2021 Jun 14; 22(1):394.T

Abstract

BACKGROUND

There 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).

METHODS

We 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).

DISCUSSION

This 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 REGISTRATION

ClinicalTrials.gov NCT03035851 . Registered on 30 January 2017.

Authors+Show Affiliations

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

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

34127029

Citation

Krüger, Renata L., et al. "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, vol. 22, no. 1, 2021, p. 394.
Krüger RL, Clark CM, Dyck AM, et al. 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. 2021;22(1):394.
Krüger, R. L., Clark, C. M., Dyck, A. M., Anderson, T. J., Clement, F., Hanly, P. J., Hanson, H. M., Hill, M. D., Hogan, D. B., Holroyd-Leduc, J., Longman, R. S., McDonough, M., Pike, G. B., Rawling, J. M., Sajobi, T., & Poulin, M. J. (2021). 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, 22(1), 394. https://doi.org/10.1186/s13063-021-05336-z
Krüger RL, et al. 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. 2021 Jun 14;22(1):394. PubMed PMID: 34127029.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Krüger,Renata L, AU - Clark,Cameron M, AU - Dyck,Adrienna M, AU - Anderson,Todd J, AU - Clement,Fiona, AU - Hanly,Patrick J, AU - Hanson,Heather M, AU - Hill,Michael D, AU - Hogan,David B, AU - Holroyd-Leduc,Jayna, AU - Longman,R Stewart, AU - McDonough,Meghan, AU - Pike,G Bruce, AU - Rawling,Jean M, AU - Sajobi,Tolulope, AU - Poulin,Marc J, Y1 - 2021/06/14/ PY - 2020/09/09/received PY - 2021/05/21/accepted PY - 2021/6/15/entrez PY - 2021/6/16/pubmed PY - 2021/6/17/medline KW - Alzheimer’s disease KW - Behavioural support KW - Brain health KW - Cognitive function KW - Dementia KW - Physical activity KW - Sleep quality SP - 394 EP - 394 JF - Trials JO - Trials VL - 22 IS - 1 N2 - BACKGROUND: There 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). METHODS: We 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). DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov NCT03035851 . Registered on 30 January 2017. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/34127029/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05336-z DB - PRIME DP - Unbound Medicine ER -