68291
document
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 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 ) .
68292
Intervention_Physical
aerobic exercise
68293
Intervention_Physical
Aerobic exercise
68294
Intervention_Physical
aerobic exercise
68295
Intervention_Physical
moderate-intensity cycling intervention
68296
Intervention_Physical
aerobic exercise
68297
Intervention_Physical
cycling
68298
Intervention_Physical
(
68299
Intervention_Control
low-intensity stretching
68300
Intervention_Physical
)
68301
Outcome_Mental
cognition
68302
Outcome_Mental
cognitive decline
68303
Outcome_Mental
Alzheimer 's disease Assessment Scale-Cognition
68304
Outcome_Physical
Hippocampal volume
68305
Outcome_Mental
Alzheimer 's disease Assessment Scale-Cognition
68306
Outcome_Other
exercise efficacy
68307
Outcome_Other
physical function and quality of life
68308
Outcome_Other
prohibitive costs
68309
Participant_Condition
Alzheimer 's disease
68310
Participant_Condition
Alzheimer 's disease
68311
Participant_Condition
Alzheimer 's disease
68312
Participant_Age
older adults
68313
Participant_Condition
mild-to-moderate Alzheimer 's disease
68314
Participant_Sample-size
Ninety
68315
Participant_Sample-size
90