Protocol for Project FACT: a randomised controlled trial on the effect of a walking program and vitamin B supplementation on the rate of cognitive decline and psychosocial wellbeing in older adults with mild cognitive impairment [ISRCTN19227688]

van Uffelen, Jannique G. Z., Hopman-Rock, Marijke, Chin A Paw, Marijke J. M. and van Mechelen, Willem (2005) Protocol for Project FACT: a randomised controlled trial on the effect of a walking program and vitamin B supplementation on the rate of cognitive decline and psychosocial wellbeing in older adults with mild cognitive impairment [ISRCTN19227688]. BMC geriatrics, 5 Article No 18: 1-9. doi:10.1186/1471-2318-5-18


Author van Uffelen, Jannique G. Z.
Hopman-Rock, Marijke
Chin A Paw, Marijke J. M.
van Mechelen, Willem
Title Protocol for Project FACT: a randomised controlled trial on the effect of a walking program and vitamin B supplementation on the rate of cognitive decline and psychosocial wellbeing in older adults with mild cognitive impairment [ISRCTN19227688]
Journal name BMC geriatrics   Check publisher's open access policy
ISSN 1471-2318
Publication date 2005-12-23
Year available 2005
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1186/1471-2318-5-18
Open Access Status DOI
Volume 5
Issue Article No 18
Start page 1
End page 9
Total pages 9
Place of publication London, England
Publisher BioMed Central
Language eng
Subject
111712 Health Promotion
Formatted abstract
Background
The 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/Design
The 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.

Discussion
No 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.
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Sub-type: Critical review of research, literature review, critical commentary
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