The effect of regular walks on various health aspects in older people with dementia: protocol of a randomized-controlled trial

<p>Abstract</p> <p>Background</p> <p>Physical activity has proven to be beneficial for physical functioning, cognition, depression, anxiety, rest-activity rhythm, quality of life (QoL), activities of daily living (ADL) and pain in older people. The aim of this study is to investigate the effect of walking regularly on physical functioning, the progressive cognitive decline, level of depression, anxiety, rest-activity rhythm, QoL, ADL and pain in older people with dementia.</p> <p>Methods/design</p> <p>This study is a longitudinal randomized controlled, single blind study. Ambulatory older people with dementia, who are regular visitors of daily care or living in a home for the elderly or nursing home in the Netherlands, will be randomly allocated to the experimental or control condition. Participants of the experimental group make supervised walks of 30 minutes a day, 5 days a week, as part of their daily nursing care. Participants of the control group will come together three times a week for tea or other sedentary activities to control for possible positive effects of social interaction. All dependent variables will be assessed at baseline and after 6 weeks, and 3, 6, 9, 12 and 18 months of intervention.</p> <p>The dependent variables include neuropsychological tests to assess cognition, physical tests to determine physical functioning, questionnaires to assess ADL, QoL, level of depression and anxiety, actigraphy to assess rest-activity rhythm and pain scales to determine pain levels. Potential moderating variables at baseline are: socio-demographic characteristics, body mass index, subtype of dementia, apolipoprotein E (ApoE) genotype, medication use and comorbidities.</p> <p>Discussion</p> <p>This study evaluates the effect of regular walking as a treatment for older people with dementia. The strength of this study is that 1) it has a longitudinal design with multiple repeated measurements, 2) we assess many different health aspects, 3) the intervention is not performed by research staff, but by nursing staff which enables it to become a routine in usual care. Possible limitations of the study are that 1) only active minded institutions are willing to participate creating a selection bias, 2) the drop-out rate will be high in this population, 3) not all participants will be able to perform/understand all tests.</p> <p>Trial registration</p> <p><a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1482">NTR1482</a></p

Establishing normative data for repeated cognitive assessment: A comparison of different statistical methods

Serial cognitive assessment is conducted to monitor changes in the cognitive abilities of patients over time. At present, mainly the regression-based change and the ANCOVA approaches are used to establish normative data for serial cognitive assessment. These methods are straight-forward, but they have some severe drawbacks. For example, they can only consider the data of two measurement occasions. In this article, we propose three alternative normative methods that are not hampered by these problems-that is, multivariate regression, the standard linear mixed model (LMM), and the linear mixed model combined with multiple imputation (LMM with MI) approaches. The multivariate regression method is primarily useful when a small number of repeated measurements are taken at fixed time points. When the data are more unbalanced, the standard LMM and the LMM with MI methods are more appropriate because they allow for a more adequate modeling of the covariance structure. The standard LMM has the advantage that it is easier to conduct and that it does not require a Monte Carlo component. The LMM with MI, on the other hand, has the advantage that it can flexibly deal with missing responses and missing covariate values at the same time. The different normative methods are illustrated on the basis of the data of a large longitudinal study in which a cognitive test (the Stroop Color Word Test) was administered at four measurement occasions (i.e., at baseline and 3, 6, and 12 years later). The results are discussed and suggestions for future research are provided