Promoting healthy ageing with cognitive exercise: the Pace Study

Background: Research evidence from observational studies suggests that cognitive activity reduces the risk of cognitive impairment in later life as well as the rate of cognitive decline of people with dementia. The Promoting Healthy Ageing with Cognitive Exercise (PACE) study has been designed to determine whether a cognitive activity intervention decreases the rate of cognitive decline amongst older adults with mild cognitive impairment (MCI). Methods/Design: The study will recruit 160 community-dwelling men and women aged 65 years of age or over with mild cognitive impairment (MCI). Participants will be randomly allocated to two treatment groups: non-specific education and cognitive activity. The intervention will consist of ten 90-minute sessions delivered twice per week over a period of five weeks. The primary outcome measure of the study is the change from baseline in the total score on the Cambridge Cognitive Score (CAMCOG). Secondary outcomes of interest include changes in memory, attention, executive functions, mood and quality of life. Primary endpoints will be collected 12, 52 and 104 weeks after the baseline assessment. Discussion: The proposed project will produce the best available evidence on the merits of increased cognitive activity as a strategy to prevent cognitive decline among older adults with MCI. We anticipate that the results of this study will have implications for the development of evidencebased preventive strategies to reduce the rate of cognitive decline amongst older people at risk of dementia. Trial registration: ACTRN12608000556347 Background The World's population is ageing rapidly and so is the frequency of age-related disorders. Dementia is one of the most frequent mental health disorders of older people and a leading cause of years of life lost due to disability [1]. Mild Cognitive Impairment (MCI) in old age is conPublished: 14 December 2009 Trials 2009, 10:114 doi:10.1186/1745-6215-10-114 Received: 8 October 2009 Accepted: 14 December 2009 This article is available from: http://www.trialsjournal. com/content/10/1/114 © 2009 Vidovich et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Page 1 of 8 (page number not for citation purposes) Trials 2009, 10:114 http://www.trialsjournal. com/content/10/1/114 sidered an important clinical state potentially predictive of future cognitive decline. The term MCI has been used to describe a heterogeneous group of older adults, who, whilst not fulfilling diagnostic criteria for dementia, demonstrate cognitive abilities at a level below what is considered normal for their age. Cognitive deficits may be apparent across unitary or multiple domains though the person continues to maintain a high level of functional independence [2]. Whilst this diagnostic group is at increased risk for conversion to dementia, a substantial number of individuals remain stable or even return to normal levels of functioning with time [3]. There is increasing evidence that the onset of dementia can be delayed by targeting relevant risk factors. In older adults, frequent participation in mentally stimulating leisure activities has been associated with stronger cognitive abilities (such as memory) and reduced risk of dementia [4,5]. The idea that mentally stimulating activity can influence cognitive processes is akin to the "use it or lose it" adage [6]. Few randomised controlled studies have explored this notion and critical evaluation of the research on this topic reveals a number of methodological limitations. These include the specific nature of some of the participant cohorts, the tests used to measure cognitive functioning, and the complexity associated with identifying and defining a broad range of leisure activities with regard to type and degree of cognitive stimulation (see [6] for a review). Cognition-focused interventions (cognitive training, cognitive rehabilitation and cognitive stimulation) attempt to make use of intact domains to help maintain cognition and prevent/delay decline. These techniques have also been employed to increase functional independence and reduce caregiver burden (see [7] for a review). Similar to mentally stimulating leisure activities, cognitive stimulation (CS) is a type of intervention that emphasises the benefits of group activities focussing on education, discussion and debate, and problem solving. In contrast, cognitive rehabilitation (CR) can be tailored towards an individual's needs, with consideration given to specific areas of impairment and an emphasis on improving everyday functioning. Another commonly used strategy is cognitive training (CT), which aims to provide the individual with a set of standardised tasks that they repeatedly perform. CT using specifically designed computer programs has become a burgeoning business and is generating increasing scientific interest. Collectively, the research in this area has revealed that older adults (with and without dementia) show modest gains across areas related to the target intervention, and improvements on subjective measures assessing aspects of mood and quality of life have also been observed [8]. However, there is a paucity of randomised controlled trials in this area, limiting conclusions that can be drawn from existing data. We have designed a single-blind, randomised controlled trial of an intervention that draws on methods of cognition-focussed approaches, selected with regard to suitability for older adults with MCI, and combined into a package considered interesting, engaging and acceptable to this group. The primary focus of this research is to determine whether a structured program of cognitive activity (CA) can decrease the rate of cognitive decline amongst older adults with MCI over 24 months. We hypothesize that participants allocated to the CA group will experience less cognitive decline than older adults randomised to a control education intervention. Methods/Design Background The Promoting Healthy Ageing with Cognitive Exercise (PACE) study is a randomised controlled trial that commenced recruitment of participants in March 2007. In late 2006, eight individuals with MCI, aged 60 years and over, were invited to offer their opinions regarding the development of a program of cognitive activity (CA), specifically designed for older adults with cognitive decline. The group confirmed the merit of such research and provided feedback with respect to the elements needed to be incorporated into the designed intervention. The general consensus was that any CA program needed to be challenging, personally stimulating and to have a social component. In February 2007, the CA and educational interventions forming the basis of the PACE study were piloted with 10 participants (five allocated to each intervention), aged 65 and over with MCI. These individuals attended on a daily basis over a two week period and were asked to provide written feedback regarding the session material. The proposed interventions were well received, with positive feedback regarding the relevance of the content/material, format and delivery style. The education group described the program as "useful" and "informative" and the CA group, "encouraging" and "practically helpful". After collating the feedback, additional, minor modifications were made to the study protocol and recruitment began. Participants Recruitment of older persons Participants were community dwelling volunteers recruited from various sources such as memory clinics, local media and other ongoing research studies. Potential participants were initially screened with a semi-structured Page 2 of 8 (page number not for citation purposes) Trials 2009, 10:114 http://www.trialsjournal. com/content/10/1/114 interview over the telephone and invited to visit the Western Australia Centre for Health and Ageing (WACHA), Royal Perth Hospital (RPH) for a more detailed screening assessment (clinical screen) and to provide written informed consent. The Ethics Committee of the RPH has approved the study protocol and procedures. Inclusion and Exclusion Criteria The most important defining feature of participants included in the PACE study was a diagnosis of MCI, which was ascertained at a screening assessment at the WACHA (discussed in further detail below). Individuals needed to be aged 65 years or over at their last birthday and be willing and able to travel to the WACHA. All were proficient in spoken and written English. Individuals with a diagnosis of dementia according to ICD-10 criteria for Research [9] or suffering notable cognitive impairment, as evidenced by a Mini Mental State Examination (MMSE; [10]) score of 23 or less, were excluded from the study. Additional exclusion criteria included current psychiatric disorder (e.g. depressive episode), and current history of hazardous or harmful alcohol consumption (based on the Australian Alcohol Guidelines endorsed by the National Health and Medical Research Council 2001). Those individuals with a current medical condition that prevented participation in the study tasks (such as sensory impairment) or was associated with reduced survival over a 12 month period (e.g. advanced cancer) were excluded. We also excluded from the trial people who reported a clinical history of stroke associated with permanent disability. Telephone Interview Volunteers were initially screened via a telephone interview to ascertain individuals' concerns regarding their memory. Those indicating that they had received a diagnosis of dementia were immediately excluded. The remainder were then asked about general health both past and current concerns as well as education and English literacy skills. Details regarding current alcohol consumption were also collected and all p