The effect of an interactive cycling training on cognitive functioning in older adults with mild dementia: study protocol for a randomized controlled trial.
To date there is no cure or an effective disease-modifying drug to treat dementia. Available acetylcholine-esterase inhibiting drugs or memantine only produce small benefits on cognitive and behavioural functioning and their clinical relevance remains controversial. Combined cognitive-aerobic interventions are an appealing alternative or add-on to current pharmacological treatments. The primary aim of this study is to investigate the efficacy of a combined cognitive-aerobic training and a single aerobic training compared to an active control group in older adults with mild dementia. We expect to find a beneficial effect on executive functioning in both training regimes, compared to the control intervention, with the largest effect in the combined cognitive-aerobic group. Secondary, intervention effects on cognitive functioning in other domains, physical functioning, physical activity levels, activities of daily living, frailty and quality of life are studied.



The design is a single-blind, randomized controlled trial (RCT) with three groups: a combined cognitive-aerobic bicycle training (interactive cycling), a single aerobic bicycle training and a control intervention, which consists of stretching and toning exercises. Older adults with mild dementia follow a 12-week training program consisting of three training sessions of 30-40 min per week. The primary study outcome is objective executive functioning measured with a neuropsychological assessment. Secondary measures are objective cognitive functioning in other domains, physical functioning, physical activity levels, activities of daily living, frailty, mood and quality of life. The three groups are compared at baseline, after 6 and 12 weeks of training, and at 24-week follow-up.



This study will provide novel information on the effects of an interactive cycling training on executive function in older adults with mild dementia. Furthermore, since this study has both a combined cognitive-aerobic training and a single aerobic training group the effectiveness of the different components of the intervention can be identified. The results of this study may be used for physical and mental activity recommendations in older adults with dementia.



The Netherlands National Trial Register NTR5581 . Registered 14 February 2016.
Department of Geriatric Medicine, Donders Institute for Brain Cognition and Behaviour, Radboud university medical center, Nijmegen, The Netherlands. Esther.Karssemeijer@radboudumc.nl.|Radboud university medical center, Radboudumc Alzheimer Center, PO 9101 (hp 925), Nijmegen, 6500 HB, The Netherlands. Esther.Karssemeijer@radboudumc.nl.
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EG
Karssemeijer
University of Groningen, University Medical Center Groningen, Center for Human Movement Sciences, Groningen, The Netherlands.
W J R
WJ
Bossers
Department of Medical Psychology, Donders Institute for Brain Cognition and Behaviour, Radboud university medical center, Nijmegen, The Netherlands.
J A
JA
Aaronson
Department of Medical Psychology, Donders Institute for Brain Cognition and Behaviour, Radboud university medical center, Nijmegen, The Netherlands.
R P C
RP
Kessels
Department of Geriatric Medicine, Donders Institute for Brain Cognition and Behaviour, Radboud university medical center, Nijmegen, The Netherlands.|Radboud university medical center, Radboudumc Alzheimer Center, PO 9101 (hp 925), Nijmegen, 6500 HB, The Netherlands.
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MG
Olde Rikkert
D000368:Aged; D001642:Bicycling; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003704:Dementia / Q000523:psychology / Q000628:therapy*; D056344:Executive Function; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D009426:Netherlands; D009483:Neuropsychological Tests; D011788:Quality of Life / Q000523:psychology; D016037:Single-Blind Method; D016896:Treatment Outcome
Aerobic training; Cognition; Combined cognitive-aerobic training; Dementia; Executive functions; Interactive cycling; Randomized controlled trial