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A Home-Based Individual Cognitive Stimulation Program for Older Adults With Cognitive Impairment: A Randomized Controlled Trial.

ABSTRACT: Objective: This study aims to assess the feasibility and meaningfulness of a home-based individual cognitive stimulation (iCS) program delivered by caregivers to persons with cognitive impairment (PwCIs). It also aims to assess whether the older adults receiving this program improved their cognitive, neuropsychiatric, and depressive symptoms and quality of life and whether their caregivers improved their mental and physical health. Methods: A randomized controlled trial (RCT) was conducted with PwCI-caregiver dyads recruited from the community. Participants were allocated to two groups: intervention (n = 28) and control (n = 24). The intervention group received the European Portuguese version of the Individual Cognitive Stimulation Program-Making a Difference 3 (MD3-P). The control group received usual care. The iCS therapy program was implemented three times a week for 12 weeks. Caregivers were supported by the researchers to deliver the sessions at home. Participants were assessed at baseline and at the end of the intervention (week 13). Feasibility and meaningfulness were assessed through the attrition rate, adherence, and degree of satisfaction with the sessions. Four interviews were conducted (after week 13) to understand participants' experiences. Results: The attrition rate was 23.1%. The dyads reported that they did not have high expectations about the iCS program before starting the study. Nevertheless, as the program evolved, caregivers noted that their family members had improved some areas of functioning. Intention-to-treat analysis based on group differences revealed a significant improvement in PwCIs' cognition, specifically in their orientation and ability to follow commands. The intervention had no impact on other variables such as caregivers' physical and mental health. Conclusion: The iCS program implemented by caregivers showed promising results in improving PwCIs' cognition. The participants who completed the intervention attributed a positive meaning to the MD3-P, confirming it as a valid non-pharmacological therapeutic approach to reducing frailty in PwCIs in community settings. Clinical Trial Registration: www.ClinicalTrials.gov, identifier [NCT03514095].

SUBMITTER: Silva R

PROVIDER: S-EPMC8645562 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundTo examine the effect of multicomponent exercise program on memory function in older adults with mild cognitive impairment (MCI), and identify biomarkers associated with improvement of cognitive functions.Methodology/principal findingsSubjects were 100 older adults (mean age, 75 years) with MCI. The subjects were classified to an amnestic MCI group (n = 50) with neuroimaging measures, and other MCI group (n = 50) before the randomization. Subjects in each group were randomized to either a multicomponent exercise or an education control group using a ratio of 1∶1. The exercise group exercised for 90 min/d, 2 d/wk, 40 times for 6 months. The exercise program was conducted under multitask conditions to stimulate attention and memory. The control group attended two education classes. A repeated-measures ANOVA revealed that no group × time interactions on the cognitive tests and brain atrophy in MCI patients. A sub-analysis of amnestic MCI patients for group × time interactions revealed that the exercise group exhibited significantly better Mini-Mental State Examination (p = .04) and logical memory scores (p = .04), and reducing whole brain cortical atrophy (p<.05) compared to the control group. Low total cholesterol levels before the intervention were associated with an improvement of logical memory scores (p<.05), and a higher level of brain-derived neurotrophic factor was significantly related to improved ADAS-cog scores (p<.05).Conclusions/significanceThe results suggested that an exercise intervention is beneficial for improving logical memory and maintaining general cognitive function and reducing whole brain cortical atrophy in older adults with amnestic MCI. Low total cholesterol and higher brain-derived neurotrophic factor may predict improvement of cognitive functions in older adults with MCI. Further studies are required to determine the positive effects of exercise on cognitive function in older adults with MCI.Trial registrationUMIN-CTR UMIN000003662 ctr.cgi&quest;function&hairsp;=&hairsp;brows&action&hairsp;=&hairsp;brows&type&hairsp;=&hairsp;summary&recptno&hairsp;=&hairsp;R000004436&language&hairsp;=&hairsp;J.

Project description:BackgroundMild Cognitive Impairment (MCI) carries a high risk of progression to Alzheimer's disease (AD) dementia. Previous clinical trials testing whether cholinesterase inhibitors can slow the rate of progression from MCI to AD dementia have yielded disappointing results. However, recent studies of the effects of repetitive transcranial magnetic stimulation (rTMS) in AD have demonstrated improvements in cognitive function. Because few rTMS trials have been conducted in MCI, we designed a trial to test the short-term efficacy of rTMS in MCI. Yet, in both MCI and AD, we know little about what site of stimulation would be ideal for improving cognitive function. Therefore, two cortical sites will be investigated in this trial: (1) the dorsolateral prefrontal cortex (DLPFC), which has been well studied for treatment of major depressive disorder; and (2) the lateral parietal cortex (LPC), a novel site with connectivity to AD-relevant limbic regions.Methods/designIn this single-site trial, we plan to enroll 99 participants with single or multi-domain amnestic MCI. We will randomize participants to one of three groups: (1) Active DLPFC rTMS; (2) Active LPC rTMS; and (3) Sham rTMS (evenly split between DLPFC and LPC locations). After completing 20 bilateral rTMS treatment sessions, participants will be followed for 6 months to test short-term efficacy and track durability of effects. The primary efficacy measure is the California Verbal Learning Test-II (CVLT-II), assessed 1 week after intervention. Secondary analyses will examine effects of rTMS on other cognitive measures, symptoms of depression, and brain function with respect to the site of stimulation. Finally, selected biomarkers will be analyzed to explore predictors of response and mechanisms of action.DiscussionThe primary aim of this trial is to test the short-term efficacy of rTMS in MCI. Additionally, the project will provide information on the durability of cognitive effects and potentially distinct effects of stimulating DLPFC versus LPC regions. Future efforts would be directed toward better understanding therapeutic mechanisms and optimizing rTMS for treatment of MCI. Ultimately, if rTMS can be utilized to slow the rate of progression to AD dementia, this will be a significant advancement in the field.Trial registrationClinical Trials NCT03331796. Registered 6 November 2017, https://clinicaltrials.gov/ct2/show/NCT03331796. All items from the World Health Organization Trial Registration Data Set are listed in Appendix A.Protocol versionThis report is based on version 1, approved by the DSMB on 30 November, 2017 and amended on 14 August, 2018 and 19 September, 2019.

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A Home-Based Individual Cognitive Stimulation Program for Older Adults With Cognitive Impairment: A Randomized Controlled Trial.

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