Abstract
BackgroundObservational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer's disease. The Fitness for the Ageing Brain II (FABS II) study is a multicentre randomized controlled clinical trial (RCT) aiming to determine whether physical activity reduces the rate of cognitive decline among individuals with Alzheimer's disease. This paper describes the background, objectives of the study, and an overview of the protocol including design, organization and data collection methods.Methods/DesignThe study will recruit 230 community-dwelling participants diagnosed with Alzheimer's disease. Participants will be randomly allocated to two treatment groups: usual care group or 24-week home-based program consisting of 150 minutes per week of tailored moderate physical activity. The primary outcome measure of the study is cognitive decline as measured by the change from baseline in the total score on the Alzheimer's disease Assessment Scale-Cognitive section. Secondary outcomes of interest include behavioral and psychological symptoms, quality of life, functional level, carer burden and physical function (strength, balance, endurance, physical activity). Primary endpoints will be measured at six and twelve months following the baseline assessment.DiscussionThis RCT will contribute evidence regarding the potential benefits of a systematic program of physical activity as an affordable and safe intervention for people with Alzheimer's disease. Further, if successful, physical activity in combination with usual care has the potential to alleviate the symptoms of Alzheimer's disease and improve its management and the quality of life of patients and their carers.Trial RegistrationAustralia New Zealand Clinical Trials Registry ACTRN12609000755235
Highlights
Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer’s disease
This randomized controlled clinical trial (RCT) will contribute evidence regarding the potential benefits of a systematic program of physical activity as an affordable and safe intervention for people with Alzheimer’s disease
Few RCTs have tested the effect of physical activity in community dwelling people with Alzheimer’s disease (AD), and none have assessed the beneficial effects of physical activity in terms of family caregiver burden and wellbeing [21]
Summary
Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer’s disease. The Fitness for the Ageing Brain II (FABS II) study is a multicentre randomized controlled clinical trial (RCT) aiming to determine whether physical activity reduces the rate of cognitive decline among individuals with Alzheimer’s disease. Available projections indicate that the number of people with dementia worldwide will increase from 35.6 million in 2010 to 115.4 million people by 2050 [2], Alzheimer’s disease is characterized by a progressive deterioration in memory and other higher cortical functions that leads to a loss of independent living skills [3]. The association between PA and cognitive function was evident even when exercise is limited to later life [12]. As Leone et al [13] noted, these findings are limited by methodological issues such as survivorship bias and confounding, the latter arising because the exposure to PA is not random in observational studies
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