Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial)

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• 作者：Fang Yu ; Ulf G Bronas ; Suma Konety ; Nathaniel W Nelson ; Maurice Dysken…
• 关键词：Exercise ; Alzheimer’s disease ; Dementia ; Physical activity ; Cognition ; Hippocampal volume ; Imaging
• 刊名：Trials
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：15
• 期：1
• 全文大小：559 KB
• 参考文献：Dementia: a public health priority.
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• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Alzheimer’s disease, a global public health issue, accounts for 60 to 80% of all dementias. Alzheimer’s disease primarily causes cognitive impairment and drugs have only modest short-term effects, highlighting a pressing need to develop effective interventions. Aerobic exercise holds promise for treating cognitive impairment in Alzheimer’s disease through biologically sound mechanisms. Nonetheless, aerobic exercise studies in Alzheimer’s disease are limited with mixed findings. Methods/Design This pilot randomized controlled trial will investigate the effects of a 6-month, individualized, moderate-intensity cycling intervention (20 to 50?minutes per session, 3 times a week) on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate Alzheimer’s disease. The specific aims are to: 1) determine the immediate effect of the cycling intervention on cognition in Alzheimer’s disease; 2) examine if the cycling intervention slows cognitive decline in Alzheimer’s disease from baseline to 12?months; and 3) assess the effect of aerobic exercise on hippocampal volume over 12?months. Ninety subjects will be randomized on a 2:1 allocation ratio to cycling or attention control (low-intensity stretching) and followed for another 6?months. Allocations will be concealed to all investigators and outcome assessors will be blinded to group assignments and previous data. Cognition will be measured by the Alzheimer’s disease Assessment Scale-Cognition at baseline before randomization and at 3, 6, 9, and 12?months. Hippocampal volume will be measured by magnetic resonance imaging at baseline and 6 and 12?months. The sample size of 90 will give 80% power to detect a 2.5-point difference in within-group changes in the Alzheimer’s disease Assessment Scale-Cognition at 6?months for the cycling group. Discussion Findings from this study will address the critical gap of exercise efficacy in Alzheimer’s disease and use of magnetic resonance imaging as an outcome measure in clinical trials. This study will provide a potential treatment that may increase physical function and quality of life and curb the prohibitive costs for the growing dementia population. Trial registration Primary registration: (NCT01954550; date of registration: 20 September 2013). Secondary registration: (NCT01954550; date of registration: 1 October 2013).