Abstract

Backgroundthe prevalence of individuals with cognitive decline is increasing since the number of elderly adults is growing considerably. The literature provides promising results on the beneficial effect of exercise and vitamin supplementation on cognitive function both in cognitively healthy as well as in the demented elderly.Methods/Designthe design is a two-by-two factorial randomised controlled trial. The study population consists of independently living elderly, between 70 and 80 years old, with mild cognitive impairment (MCI). In the RCT the effect of two interventions, a walking program and vitamin supplementation, is examined. The walking program (WP) is a group-based program aimed at improving cardiovascular endurance; frequency two lessons a week; lesson duration one hour; program duration one year. Non-walking groups receive a placebo activity program (PAP) (i.e. low intensive non-aerobic group exercises, like stretching) with the same frequency, lesson and program duration. Vitamin supplementation consists of a single daily vitamin supplement containing 50 mg B6, 5 mg folic acid and 0,4 mg B12 for one year. Subjects not receiving vitamin supplements are daily taking an identically looking placebo pill, also for a year. Participants are randomised to four groups 1) WP and vitamin supplements; 2) WP and placebo supplements; 3) PAP and vitamin supplements; 4) PAP and placebo supplements. Primary outcome measures are measures of cognitive function. Secondary outcomes include psychosocial wellbeing, physical activity, cardiovascular endurance and blood vitamin levels.Discussionno large intervention study has been conducted yet on the effect of physical activity and vitamin supplementation in a population-based sample of adults with MCI. The objective of the present article is to describe the design of a randomised controlled trial examining the effect of a walking program and vitamin B supplementation on the rate of cognitive decline in older adults with MCI.

Highlights

  • Because cognitive function decreases with age and the number of elderly is increasing worldwide, the number of older adults with cognitive dysfunction is increasing

  • Mild cognitive impairment mild cognitive impairment (MCI) refers to a stage in which persons experience memory loss to a greater extent than one would expect for age, but do not yet meet currently accepted criteria for clinically probable dementia or Alzheimer Disease (AD) [1]

  • Progression rates to dementia and AD for adults with MCI vary from 6 % to 25 % per year, depending on the criteria for MCI [6]

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Summary

Introduction

Because cognitive function decreases with age and the number of elderly is increasing worldwide, the number of older adults with cognitive dysfunction is increasing. Since no cure for dementia is available yet, this process will put a considerable burden on the healthcare system and on society in general. For both individuals and society it is necessary to develop strategies for maintaining physical, mental and cognitive wellbeing of the aging population. In this manuscript the design is described of a randomised controlled trial on the effect of a moderate intensive walking program and vitamin B-supplementation in an older population with mild cognitive impairment (MCI) recruited from the general population. The rate of progression to AD in adults with MCI according to the criteria of Petersen et al is 12%, compared with a rate of 1–2% per year in control subjects [4]

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