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Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial)
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 pro...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4283145/ https://www.ncbi.nlm.nih.gov/pubmed/25304364 http://dx.doi.org/10.1186/1745-6215-15-394 |
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author | Yu, Fang Bronas, Ulf G Konety, Suma Nelson, Nathaniel W Dysken, Maurice Jack, Clifford Wyman, Jean F Vock, David Smith, Glenn |
author_facet | Yu, Fang Bronas, Ulf G Konety, Suma Nelson, Nathaniel W Dysken, Maurice Jack, Clifford Wyman, Jean F Vock, David Smith, Glenn |
author_sort | Yu, Fang |
collection | PubMed |
description | 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). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-15-394) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4283145 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42831452015-01-06 Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial) Yu, Fang Bronas, Ulf G Konety, Suma Nelson, Nathaniel W Dysken, Maurice Jack, Clifford Wyman, Jean F Vock, David Smith, Glenn Trials Study Protocol 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). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-15-394) contains supplementary material, which is available to authorized users. BioMed Central 2014-10-11 /pmc/articles/PMC4283145/ /pubmed/25304364 http://dx.doi.org/10.1186/1745-6215-15-394 Text en © Yu et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Yu, Fang Bronas, Ulf G Konety, Suma Nelson, Nathaniel W Dysken, Maurice Jack, Clifford Wyman, Jean F Vock, David Smith, Glenn Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial) |
title | Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial) |
title_full | Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial) |
title_fullStr | Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial) |
title_full_unstemmed | Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial) |
title_short | Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial) |
title_sort | effects of aerobic exercise on cognition and hippocampal volume in alzheimer’s disease: study protocol of a randomized controlled trial (the fit-ad trial) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4283145/ https://www.ncbi.nlm.nih.gov/pubmed/25304364 http://dx.doi.org/10.1186/1745-6215-15-394 |
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