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Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol.

ABSTRACT: Healthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual's level of alertness. The control of alertness also significantly declines with age and contributes to increased lapses of attention in everyday life, ranging from minor memory slips to a lack of vigilance and increased risk of falls or motor-vehicle accidents. Several experimental behavioral therapies designed to remediate age-related cognitive decline have been developed, but differ widely in content, method and dose. Preliminary studies demonstrate that Tonic and Phasic Alertness Training (TAPAT) can improve executive functions in older adults and may be a useful adjunct treatment to enhance benefits gained in other clinically validated treatments. The purpose of the current trial (referred to as the Attention training for Learning Enhancement and Resilience Trial or ALERT) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes.We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 120 patients with age-related cognitive decline. Patients will be asked to complete 36 training sessions remotely (30 min/day, 5 days a week, over 3 months) of either the experimental TAPAT training program or an active control computer games condition. Patients will be assessed on a battery of cognitive and functional outcomes at four time points, including: a) immediately before training, b) halfway through training, c) within forty-eight hours post completion of total training, and d) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects.The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in adults with age-related cognitive decline; employs highly sensitive computer-based assessments of cognition as well as functional abilities, and incorporates a large sample size in an RCT design.ClinicalTrials.gov identifier: NCT02416401.

SUBMITTER: VanVleet T

PROVIDER: S-EPMC5934832 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol.

VanVleet Thomas T Voss Michelle M Dabit Sawsan S Mitko Alex A DeGutis Joseph J

BMC psychology 20180503 1

<h4>Background</h4>Healthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual's level of alertness. The control of alertness also significantly declines with age and contributes to increased lapses of attention in everyday life, ranging from minor memory slips to a lack of vigilance and ...[more]

PMID: 29724228

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Project description:BackgroundFalls are a common cause of injuries and hospitalization among older adults. While conventional balance training appears effective in preventing falls, a relatively large number of training sessions are needed and retention of the effects after the training period is hard to accomplish. This may be because these interventions are not sufficiently task-specific for the mechanism of falls. Many falls in older adults occur due to unexpected external perturbations during gait, such as trips. Therefore, there is increasing interest in perturbation-based balance training (PBT), which is a more task-specific intervention to improve reactive balance control after unexpected perturbations. The literature suggests that PBT may be more effective and require fewer training sessions to reduce falls incidence in older adults, than conventional balance training. We aim to evaluate the effect of a three-session PBT protocol on balance control, daily life falls and fear of falling. Secondly, we will evaluate the acceptability of the PBT protocol.MethodsThis is a mixed-methods study combining a single-blind (outcome assessor) randomized controlled trial (RCT) using a parallel-group design, and qualitative research evaluating the acceptability of the intervention. The study sample consists of community-dwelling older adults aged 65 years and older who have recently fallen and visited the MUMC+ outpatient clinic. Subjects are randomized into two groups. The control group (n = 40) receives usual care, meaning referral to a physical therapist. The intervention group (n = 40) receives usual care plus three 30-min sessions of PBT in the Computer Assisted Rehabilitation Environment. Subjects' balance control (Mini-BESTest) and fear of falling (FES-I) will be assessed at baseline, and 4 weeks and 3 months post-baseline. Daily life falls will be recorded with falls calendars until 6 months after the first follow-up measurement, long-term injurious falls will be recorded at 2-years' follow-up via the electronic patient record. Acceptability of the PBT protocol will be evaluated with semi-structured interviews in a subsample from the intervention group.DiscussionThis study will contribute to the evidence for the effectiveness of PBT using a training protocol based on the available literature, and also give much needed insights into the acceptability of PBT for older adults.Trial registrationNederlands Trial Register NL7680 . Registered 17-04-2019 - retrospectively registered.

Project description:ObjectiveCombined physical (PHY) and cognitive (COG) training in sequential (SEQ) and simultaneous (SIMUL) sessions may delay the progression of cognitive impairment. To date, no study has directly compared in older adults with cognitive impairment the effects of COG training, PHY training, SEQ motor-cognitive training and SIMUL motor-cognitve training on specific indices of cognitive performance and activities of daily living (ADL). The purpose of this study was to determine whether SEQ and SIMUL motor-cognitive training can improve treatment outcomes compared with PHY or COG training alone. We also aimed to compare the effects of SEQ versus SIMUL motor-cognitive training on cognitive functions and instrumental ADL (IADL) in older adults with cognitive impairment.MethodsA cluster randomized controlled trial was conducted. Eighty older adults with cognitive impairment were randomly assigned to COG, PHY, SEQ or SIMUL training groups. The intervention consisted of 90-min training sessions, totaling 36 sessions. Outcome measures were the Montreal Cognitive Assessment, three subtests of the Wechsler Memory Scale (WMS) and the Lawton IADL scale.ResultsSignificant interaction effects between group and time were found in WMS-spatial span (p = 0.04) and WMS-word lists (p = 0.041). For WMS-spatial span, the SIMUL group showed outperformed the COG (p = 0.039), PHY (p = 0.010) and SEQ groups (p = 0.017). For WMS-word lists, the SEQ group improve more than COG (p = 0.013), PHY (p = 0.030) and SIMUL (p = 0.019) groups. No significant differences were found in IADL performance among four groups (p = 0.645).ConclusionsOur study showed SEQ and SIMUL motor-cognitive training led to more pronounced improvements in visuospatial working memory or verbal memory compared with isolated COG or PHY training for community-based older adults with cognitive impairment. For enhancing effects on IADL, we suggest the use of sensitive measurement tools and context-enriched cognitive training involving real-life task demands.

Project description:BACKGROUND:Previous research suggests that both cognitive training and physical exercise help to maintain brain health and cognitive functions that decline with age. Some studies indicate that combined interventions may produce larger effects than each intervention alone. The aim of this study is to investigate the effects of combined cognitive and physical training compared to cognitive training and physical training alone on executive control and memory functions in healthy older adults. OBJECTIVES:The main objectives of this four-arm randomized controlled trial (RCT) are: to investigate the synergetic effects of a simultaneous, group-based multidomain training program that combines cognitive video-game training with physical exercise, in comparison to those produced by cognitive training combined with physical control activity, physical training combined with cognitive control activity, or a combination of both control activities; to investigate whether event-related potential latencies of the P2 component are shorter and N2 and P3b components assessed in a memory-based task switching task are enhanced after training; and to find out whether possible enhancements persist after a 3-month period without training. METHODS:In this randomized, single-blind, controlled trial, 144 participants will be randomly assigned to one of the four combinations of cognitive training and physical exercise. The cognitive component will be either video-game training (cognitive intervention, CI) or video games not specifically designed to train cognition (cognitive control, CC). The physical exercise component will either emphasize endurance, strength, and music-movement coordination (exercise intervention, EI) or stretching, toning, and relaxation (exercise control, EC). DISCUSSION:This RCT will investigate the short and long-term effects of multidomain training, compared to cognitive training and physical training alone, on executive control and memory functions in healthy older adults, in comparison with the performance of an active control group. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03823183. Registered on 21 January 2019.

Project description:Cognitive control is defined by a set of neural processes that allow us to interact with our complex environment in a goal-directed manner. Humans regularly challenge these control processes when attempting to simultaneously accomplish multiple goals (multitasking), generating interference as the result of fundamental information processing limitations. It is clear that multitasking behaviour has become ubiquitous in today's technologically dense world, and substantial evidence has accrued regarding multitasking difficulties and cognitive control deficits in our ageing population. Here we show that multitasking performance, as assessed with a custom-designed three-dimensional video game (NeuroRacer), exhibits a linear age-related decline from 20 to 79 years of age. By playing an adaptive version of NeuroRacer in multitasking training mode, older adults (60 to 85 years old) reduced multitasking costs compared to both an active control group and a no-contact control group, attaining levels beyond those achieved by untrained 20-year-old participants, with gains persisting for 6 months. Furthermore, age-related deficits in neural signatures of cognitive control, as measured with electroencephalography, were remediated by multitasking training (enhanced midline frontal theta power and frontal-posterior theta coherence). Critically, this training resulted in performance benefits that extended to untrained cognitive control abilities (enhanced sustained attention and working memory), with an increase in midline frontal theta power predicting the training-induced boost in sustained attention and preservation of multitasking improvement 6 months later. These findings highlight the robust plasticity of the prefrontal cognitive control system in the ageing brain, and provide the first evidence, to our knowledge, of how a custom-designed video game can be used to assess cognitive abilities across the lifespan, evaluate underlying neural mechanisms, and serve as a powerful tool for cognitive enhancement.

Project description:BackgroundLoss of functional capabilities due to inactivity is one of the most common reasons for fall accidents, and it has been well established that loss of capabilities can be effectively reduced by physical activity. Pilot studies indicate a possible improvement in functional abilities of community dwelling elderly as a result of short-term playing with an exergame system in the form of interactive modular tiles. Such playful training may be motivational to perform and viewed by the subjects to offer life-fulfilling quality, while providing improvement in physical abilities, e.g. related to prevent fall accidents. The RCT will test for a variety of health parameters of community-dwelling elderly playing on interactive modular tiles.MethodsThe study will be a single blinded, randomized controlled trial with 60 community-dwelling adults 70+ years. The trial will consist an intervention group of 30 participants training with the interactive modular tiles, and a control group of 30 participants that will receive the usual care provided to non-patient elderly. The intervention period will be 12 weeks. The intervention group will perform group training (4-5 individuals for 1 h training session with each participant receiving 13 min training) on the interactive tiles twice a week. Follow-up tests include 6-min Walk Test (6MWT), the 8-ft Timed Up & Go Test (TUG), and the Chair-Stand Test (CS) from the Senior Fitness Test, along with balancing tests (static test on Wii Board and Line Walk test). Secondary outcomes related to adherence, motivation and acceptability will be investigated through semi-structured interviews. Data will be collected from pre- and post-tests. Data will be analyzed for statistically significant differences by checking that there is a Gaussian distribution and then using paired t-test, otherwise using Wilcoxon signed-rank test. "Intention to treat" analysis will be done.DiscussionThe trial tests for increased mobility, agility, balancing and general fitness of community-dwelling elderly as a result of playing, in this case on modular interactive tiles. A positive outcome may help preventing loss of functional capabilities due to inactivity.Trial registrationClinicalTrials.gov: Nr. NCT02496702 , Initial Release date 7/7-2015.

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Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol.

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Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol.

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