SMART: physical activity and cerebral metabolism in older people: study protocol for a randomised controlled trial

Johannes Fleckenstein, Silke Matura, Tobias Engeroff, Eszter Füzéki, Valentina A Tesky, Ulrich Pilatus, Elke Hattingen, Ralf Deichmann, Lutz Vogt, Winfried Banzer, Johannes Pantel, Johannes Fleckenstein, Silke Matura, Tobias Engeroff, Eszter Füzéki, Valentina A Tesky, Ulrich Pilatus, Elke Hattingen, Ralf Deichmann, Lutz Vogt, Winfried Banzer, Johannes Pantel

Abstract

Background: Physical activity exerts a variety of long-term health benefits in older adults. In particular, it is assumed to be a protective factor against cognitive decline and dementia.

Methods/design: Randomised controlled assessor blinded 2-armed trial (n = 60) to explore the exercise- induced neuroprotective and metabolic effects on the brain in cognitively healthy older adults. Participants (age ≥ 65), recruited within the setting of assisted living facilities and newspaper advertisements are allocated to a 12-week individualised aerobic exercise programme intervention or a 12-week waiting control group. Total follow-up is 24 weeks. The main outcome is the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging reflecting changes of cerebral N-acetyl-aspartate and of markers of neuronal energy reserve. Imaging also measures changes in cortical grey matter volume. Secondary outcomes include a broad range of psychometric (cognition) and movement-related parameters such as nutrition, history of physical activity, history of pain and functional diagnostics. Participants are allocated to either the intervention or control group using a computer-generated randomisation sequence. The exercise physiologist in charge of training opens sealed and opaque envelopes and informs participants about group allocation. For organisational reasons, he schedules the participants for upcoming assessments and exercise in groups of five. All assessors and study personal other than exercise physiologists are blinded.

Discussion: Magnetic Resonance Spectroscopic Imaging gives a deeper insight into mechanisms of exercise-induced changes in brain metabolism. As follow-up lasts for 6 months, this study is able to explore the mid-term cerebral metabolic effects of physical activity assuming that an individually tailored aerobic ergometer training has the potential to counteract brain ageing.

Trial registration: NCT02343029 (clinicaltrials.gov; 12 January 2015).

Figures

Figure 1
Figure 1
Study design. The figure details the dates in which participants are assessed or receive intervention. After screening at baseline, participants pass three visits (Visits 1a-c) at the respective departments; that is, the Institute of General Practice for psychometric testing, the Department of Sports Medicine for movement-related testing and the Institute of Neuroradiology for the conduction of the magnetic resonance (MR) protocol. Participants fulfilling all inclusion criteria are than randomly allocated to two groups: the intervention group (INT) or the waiting control group (CON). In the INT group, participants start a 12-week individualised aerobic exercise programme on a bicycle ergometer whereas in the CON group they continue their used daily activity for another 12 weeks. After 12 weeks, participants are reassessed at the above mentioned departments (Visits 2a-c). Participants in the CON group can now decide to perform the exercise programme too. Follow-up ends at 24 weeks (Visits 3a-c).

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