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The fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer’s disease


Cyarto, Elizabeth V., Cox, Kay L., Almeida, Osvaldo P., Flicker, Leon, Ames, David, Byrne, Gerard, Hill, Keith D., Beer, Christopher D., LoGiudice, Dina, Appadurai, Kana, Irish, Muireann, Renehan, Emma, Lautenschlager, Nicola T.


Trials, Volume: 11, Pages.: 120-120

Year of Publication



Background: 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. This paper describes the background, objectives of the study, and an overview of the protocol including design, organization and data collection methods.; Methods/design: The 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.; Discussion: This 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 Registration: Australia New Zealand Clinical Trials Registry ACTRN12609000755235.;

Bibtex Citation

@article{Cyarto_2010, doi = {10.1186/1745-6215-11-120}, url = {}, year = 2010, month = {dec}, publisher = {Springer Nature}, volume = {11}, number = {1}, author = {Elizabeth V Cyarto and Kay L Cox and Osvaldo P Almeida and Leon Flicker and David Ames and Gerard Byrne and Keith D Hill and Christopher D Beer and Dina LoGiudice and Kana Appadurai and Muireann Irish and Emma Renehan and Nicola T Lautenschlager}, title = {The fitness for the Ageing Brain Study {II} ({FABS} {II}): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer{textquotesingle}s disease}, journal = {Trials} }


alzheimer disease, clinical protocols, cognition, exercise, humans, psychology, research design

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Behaviour, Carer Burden (instruments measuring burden), Cognition, Physical Health, Quality of Life of Person With Dementia

Type of Interventions

Non-pharmacological Treatment

Non-Pharmaceutical Interventions

Exercise (inc. dancing)