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Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol.

ABSTRACT: BACKGROUND:The presence of mild cognitive impairment (MCI) in older adults increases their fall risk. While physical exercise is effective in reducing falls rate and risk of falls, and cognitive training in improving cognitive functioning in healthy older adults, their effectiveness in preventing falls and reducing risks of falls in MCI when administered simultaneously is not yet established. Therefore, this study aims to determine the effectiveness of combined physical and cognitive training in preventing falls and decreasing risks of falls among community-dwelling older persons with MCI. METHODS/DESIGN:This is a single-blind, multicentre, randomized controlled trial. At least ninety-three community-dwelling older adults with MCI aged 60 or above will be recruited. They will be randomly allocated into four groups: Physical Training alone (PT), Cognitive Training alone (CT), combined Physical And Cognitive Training (PACT) and Waitlist Group (WG). The PT group will perform exercises (flexibility, endurance, strengthening, and balance training) for 60-90 min three times per week for 12 weeks. The CT group will be involved in a paper-based training focusing on orientation, memory, attention and executive functioning for 60-90 min per session, once a week for 12 weeks. The PACT group will undergo cognitive training incorporated in physical exercise for 60-90 min three times per week for 12 weeks. The WG will receive the intervention, combined physical and cognitive training, at a later date. Assessors blinded to participant allocation will conduct pre-intervention, post-intervention, and 6-month follow-up assessments. The primary outcome measure will be falls rate. The secondary outcome measures will be Physiologic Profile Assessment and Falls Risk for Older Persons in the Community, and assessments that evaluate cognitive, physical and psychological factors related to falls. DISCUSSION:Considering the possible physical, social, financial and psychological consequences of a fall, we hope to provide insights on the effectiveness of combining physical and cognitive training on falls and fall-related factors for older adults with MCI. It is projected that the combined interventions will lead to significantly lower falls rate and reduced risk of falls compared to using single or no intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT03167840 . Registered on May 30, 2017.

SUBMITTER: Lipardo DS

PROVIDER: S-EPMC6109308 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Project description:BackgroundTherapeutic virtual reality (VR) has emerged as an effective treatment modality for cognitive and physical training in people with mild cognitive impairment (MCI). However, to replace existing nonpharmaceutical treatment training protocols, VR platforms need significant improvement if they are to appeal to older people with symptoms of cognitive decline and meet their specific needs.ObjectiveThis study aims to design and test the acceptability, usability, and tolerability of an immersive VR platform that allows older people with MCI symptoms to simultaneously practice physical and cognitive skills on a dual task.MethodsOn the basis of interviews with 20 older people with MCI symptoms (15 females; mean age 76.25, SD 5.03 years) and inputs from their health care providers (formative study VR1), an interdisciplinary group of experts developed a VR system called VRADA (VR Exercise App for Dementia and Alzheimer's Patients). Using an identical training protocol, the VRADA system was first tested with a group of 30 university students (16 females; mean age 20.86, SD 1.17 years) and then with 27 older people (19 females; mean age 73.22, SD 9.26 years) who had been diagnosed with MCI (feasibility studies VR2a and VR2b). Those in the latter group attended two Hellenic Association Day Care Centers for Alzheimer's Disease and Related Disorders. Participants in both groups were asked to perform a dual task training protocol that combined physical and cognitive exercises in two different training conditions. In condition A, participants performed a cycling task in a lab environment while being asked by the researcher to perform oral math calculations (single-digit additions and subtractions). In condition B, participants performed a cycling task in the virtual environment while performing calculations that appeared within the VR app. Participants in both groups were assessed in the same way; this included questionnaires and semistructured interviews immediately after the experiment to capture perceptions of acceptability, usability, and tolerability, and to determine which of the two training conditions each participant preferred.ResultsParticipants in both groups showed a significant preference for the VR condition (students: mean 0.66, SD 0.41, t29=8.74, P<.001; patients with MCI: mean 0.72, SD 0.51, t26=7.36, P<.001), as well as high acceptance scores for intended future use, attitude toward VR training, and enjoyment. System usability scale scores (82.66 for the students and 77.96 for the older group) were well above the acceptability threshold (75/100). The perceived adverse effects were minimal, indicating a satisfactory tolerability.ConclusionsThe findings suggest that VRADA is an acceptable, usable, and tolerable system for physical and cognitive training of older people with MCI and university students. Randomized controlled trial studies are needed to assess the efﬁcacy of VRADA as a tool to promote physical and cognitive health in patients with MCI.

Project description:Older adults with cognitive problems have a higher risk of falls, at least twice that of cognitively normal older adults. The consequences of falls in this population are very serious: fallers with cognitive problems suffer more injuries due to falls and are approximately five times more likely to be admitted to institutional care. Although the mechanisms of increased fall risk in cognitively impaired people are not completely understood, it is known that impaired cognitive abilities can reduce attentional resource allocation while walking. Since cognitive enhancers, such as cholinesterase inhibitors, improve attention and executive function, we hypothesise that cognitive enhancers may reduce fall risk in elderly people in the early stages of cognitive decline by improving their gait and balance performance due to an enhancement in attention and executive function.Double blinded randomized controlled trial with 6 months follow-up in 140 older individuals with Mild Cognitive Impairment (MCI). Participants will be randomized to the intervention group, receiving donepezil, and to the control group, receiving placebo. A block randomization by four and stratification based on fall history will be performed. Primary outcomes are improvements in gait velocity and reduction in gait variability. Secondary outcomes are changes in the balance confidence, balance sway, attention, executive function, and number of falls.By characterizing and understanding the effects of cognitive enhancers on fall risk in older adults with cognitive impairments, we will be able to pave the way for a new approach to fall prevention in this population. This RCT study will provide, for the first time, information regarding the effect of a medication designed to augment cognitive functioning have on the risk of falls in older adults with Mild Cognitive Impairment. We expect a significant reduction in the risk of falls in this vulnerable population as a function of the reduced gait variability achieved by treatment with cognitive enhancers. This study may contribute to a new approach to prevent and treat fall risk in seniors in early stages of dementia.The protocol for this study is registered with the Clinical Trials Registry, identifier number: NCT00934531 http://www.clinicaltrials.gov.

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Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol.

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