Rationale and protocol of the ENGAGE study: a double-blind randomized controlled preference trial using a comprehensive cohort design to measure the effect of a cognitive and leisure-based intervention in older adults with a memory complaint - PubMed (original) (raw)

doi: 10.1186/s13063-019-3250-6.

A Moussard 3 4, A I Ansaldo 3 4, P Belchior 4 5, L Bherer 3 4, N Bier 3 4, V D Bohbot 5 6, M-A Bruneau 3 4, L L Cuddy 7, B Gilbert 4, R Jokel 8 9, K Mahalingam 9, K McGilton 8 10, K J Murphy 8 9, G Naglie 8 9, E Rochon 8 10, A K Troyer 8 9, N D Anderson 8 9

Affiliations

Rationale and protocol of the ENGAGE study: a double-blind randomized controlled preference trial using a comprehensive cohort design to measure the effect of a cognitive and leisure-based intervention in older adults with a memory complaint

S Belleville et al. Trials. 2019.

Abstract

Background: Leisure activities can be both enjoyable and cognitively stimulating, and participation in such activities has been associated with reduced age-related cognitive decline. Thus, integrating stimulating leisure activities in cognitive training programs may represent a powerful and innovative approach to promote cognition in older adults at risk of dementia. The ENGAGE study is a randomized controlled, double-blind preference trial with a comprehensive cohort design that will test the efficacy and long-term impact of an intervention that combines cognitive training and cognitively stimulating leisure activities.

Methods: One hundred and forty-four older adults with a memory complaint will be recruited in Montreal and Toronto. A particular effort will be made to reach persons with low cognitive reserve. Participants will be randomly assigned to one of two conditions: cognitive + leisure training (ENGAGE-MUSIC/SPANISH) or active control (ENGAGE-DISCOVERY). The ENGAGE-MUSIC/SPANISH training will include teaching of mnemonic and attentional control strategies, casual videogames selected to train attention, and classes in music or Spanish as a second language. The ENGAGE-DISCOVERY condition will comprise psychoeducation on cognition and the brain, low-stimulating casual videogames and documentary viewing with discussions. To retain the leisure aspect of the activities, participants will be allowed to exclude either music or Spanish at study entry if they strongly dislike one of these activities. Participants randomized to ENGAGE-MUSIC/SPANISH who did not exclude any activity will be assigned to music or Spanish based on a second random assignment. Training will be provided in 24 2-h sessions over 4 months. Outcomes will be measured at baseline, at 4-month follow-up, and at 24-month follow-up. The primary outcome will be cognitive performance on a composite measure of episodic memory (delayed recall scores for words and face-name associations) measured at baseline and at the 4-month follow-up. Secondary outcomes will include a composite measure of attention (speed of processing, inhibition, dual tasking, and shifting), psychological health, activities of daily living, and brain structure and function and long-term maintenance measured at the 24-month follow-up. Information on cognitive reserve proxies (education and lifestyle questionnaires), sex and genotype (apolipoprotein (Apo)E4, brain-derived neurotrophic factor (BDNF), and catechol-O-methyltransferase (COMT)) will be collected and considered as moderators of training efficacy.

Discussion: This study will test whether a program combining cognitive training with stimulating leisure activities can increase cognition and reduce cognitive decline in persons at risk of dementia.

Trial registration: NCT03271190 . Registered on 5 September 2017.

Keywords: Cognitive intervention; Cognitive reserve; Cognitive training; Dementia prevention; Design; Early mild cognitive impairment; Preference trial; Stimulating leisure activities; Subjective cognitive decline.

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Conflict of interest statement

SB has been a consultant for research development on the prevention of Alzheimer’s disease for the Fondation IUGM (2016) and for Sojecci (2017 to current), and for the development of a cognitive stimulation program for the Centre de promotion de la Santé AvantÂge (2015). She has intellectual property rights on the ‘Programme de Stimulation pour une santé cognitive, Memoria, Batterie d’évaluation de la mémoire Côte-des-Neiges’ and ‘MEMO, Méthode d’Entrainement pour une Mémoire Optimale’. BG was a consultant for the development of the ‘Ateliers de stimulation pour une santé cognitive’ (2014). She has intellectual property rights on ‘MEMO, Méthode d’Entrainement pour une Mémoire Optimale’. AKT has co-authored program materials and co-leads train-the-trainer workshops for the Memory and Aging Program®. Under Baycrest’s Intellectual Property Policy, she is eligible to receive a percentage of the royalties collected on the net profit generated from these ventures.

The remaining authors declare that they have no competing interests.

Figures

Fig. 1

Fig. 1

Illustration of the study design. ADCS-ADL-PI Alzheimer’s Disease Cooperative Study—Activities of daily living—Prevention Instrument; CLSA Canadian Longitudinal Study on Aging; (f)MRI (functional) magnetic resonance imaging; V0 Phone screening interview; V1 First visit (screening); V2 Second visit (clinical assessment); V3 Third visit (neuropsychological assessment); V4 Fourth visit (neuropsychological assessment); V5 Fifth visit (MRI; includes fMRI for a subgroup of participants); V6-29 ENGAGE Intervention sessions (24 visits); V30 4-month follow-up neuropsychological assessment; V31 4-month follow-up MRI/fMRI (for a subgroup of participants); V32 & V34 24-month follow-up neuropsychological assessment; V33 24-month follow-up clinical visit; V35 24-month follow-up MRI. X: administered during the visit; ♦: given to be completed at home by next visit

Fig. 2

Fig. 2

Illustration of the videogames used to train the ‘priority’ attentional strategy. a Neuropeak dual task; b “Tap to Cook”; c “Chicken Run”

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