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Feasibility of a 6-month pilot randomised controlled trial of resistance training on cognition and brain health in Canadian older adults at-risk for diabetes: study protocol.

ABSTRACT: INTRODUCTION:Type 2 diabetes (T2D) is associated with cognitive deficits and increased risk of dementia, and thus individuals at high risk for T2D (ie, those who are overweight or prediabetic) are also at greater risk for cognitive decline. Aerobic exercise is known to preserve and improve cognitive function, but the effects of resistance training (RT) are much less known in older adults. Moreover, research on the effects of RT on cognition and brain health (structure and function) in older adults at-risk for diabetes is limited. To address this question, a 6-month RT intervention is needed. Importantly, before conducting a full-scale randomised controlled trial (RCT), we are conducting a feasibility pilot study to assess potential recruitment rates, adherence and retention in this specific population. METHODS AND ANALYSIS:We are conducting a 6-month, thrice-weekly RT RCT. Participants (aged 60-80; sedentary; fasting plasma glucose of 6.1-7.0?mmol/L or body mass index ?25) are randomised into one of two groups: (1) RT or (2) balance and tone (control). Based on other exercise trials using a similar population, we will consider our trial feasible if we have adherence and retention at 70%. Recruitment rate will be measured as time it takes to enrol 20 participants. To assess behavioural and MRI data, we will report descriptive statistics and estimation using a 95% CI. ETHICS AND DISSEMINATION:Our study has received ethics approval from the Health Sciences Research Ethics Board at Western University. As this is a small pilot study, data will only be made available to other researchers on request. Results from this study will be disseminated via academic publication. TRIAL REGISTRATION NUMBER:NCT03254381.

SUBMITTER: Furlano JA

PROVIDER: S-EPMC6797349 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Feasibility of a 6-month pilot randomised controlled trial of resistance training on cognition and brain health in Canadian older adults at-risk for diabetes: study protocol.

Furlano Joyla A JA Nagamatsu Lindsay S LS

BMJ open 20191003 10

<h4>Introduction</h4>Type 2 diabetes (T2D) is associated with cognitive deficits and increased risk of dementia, and thus individuals at high risk for T2D (ie, those who are overweight or prediabetic) are also at greater risk for cognitive decline. Aerobic exercise is known to preserve and improve cognitive function, but the effects of resistance training (RT) are much less known in older adults. Moreover, research on the effects of RT on cognition and brain health (structure and function) in ol ...[more]

PMID: 31585978

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Project description:ObjectivesResistance training (RT) is a promising strategy to slow or prevent fluid cognitive decline during aging. However, the effects of strength-specific RT programs have received little attention. The purpose of this single-group proof of concept clinical trial was to determine whether a 12-week strength training (ST) program could improve fluid cognition in healthy older adults 60 to 80 years of age, and to explore concomitant physiological and psychological changes.MethodsTwenty participants (69.1 ± 5.8 years, 14 women) completed this study with no drop-outs or severe adverse events. Baseline assessments were completed before an initial 12-week control period, then participants were re-tested at pre-intervention and after the 12-week ST intervention. The NIH Toolbox Cognition Battery and standard physical and psychological measures were administered at all three time points. During the 36 sessions of periodized ST (3 sessions per week), participants were supervised by an exercise specialist and challenged via autoregulatory load progression.ResultsTest-retest reliability over the control period was good for fluid cognition and excellent for crystallized cognition. Fluid composite scores significantly increased from pre- to post-intervention (8.2 ± 6.1%, p < 0.01, d = 1.27), while crystallized composite scores did not (-0.5 ± 2.8%, p = 0.46, d = -0.34). Performance on individual fluid instruments, including executive function, attention, working memory, and processing speed, also significantly improved. Surprisingly, changes in fluid composite scores had small negative correlations with changes in muscular strength and sleep quality, but a small positive correlation with changes in muscular power.ConclusionsThus, improvements in fluid cognition can be safely achieved in older adults using a 12-week high-intensity ST program, but further controlled studies are needed to confirm these findings. Furthermore, the relationship with other widespread physiological and psychological benefits remains unclear.

Project description:Most training programs for self-management of chronic diseases in Korea currently involve face-to-face interactions primarily in a health care setting. Therefore, older Koreans living in the community continue to seek other training opportunities for the management of chronic diseases. This has led to the development of new training methods, such as mobile health (mHealth) care, which are valuable in community centers and homes.This feasibility study (1) developed an mHealth training protocol to empower community-dwelling elderly individuals to manage their chronic diseases; (2) examined the feasibility of delivering this mHealth training protocol to elderly individuals through mobile tablets and applications (apps); and (3) discussed the contextual and methodological challenges associated with the development of this protocol.The mHealth training protocol was developed based on the eHealth Enhanced Chronic Care Model and comprised of four phases. Phase 1 included standardized technology (mobile tablets) training using guidebooks, demonstrations, and guided practice. Phase 2 included provision of standardized information about disease management that was obtained from governmental and professional health care organizations. Phase 3 included provision of training on the use of high-quality mHealth apps that were selected based on individual diagnoses. Phase 4 included encouraging the patients to practice using self-selected mHealth apps based on their individual needs. Quantitative descriptive statistics and qualitative content analyses of user evaluations were used to assess the feasibility and user acceptance of this protocol.Of the 27 older adults included in this study, 25 completed all 4 weeks of the mHealth training. The attrition rate was 7% (2/27), and the reasons included time conflicts, emotional distress, and/or family discouragement. The men required little or no training for Phase 1, and in comparison with men, women seemed to depend more on the mHealth trainers in Phase 3. Gender, level of education, and previous experience of using smartphones were associated with the speed of learning, level of confidence, and overall competence.A tailored and personalized approach is required to develop mHealth training protocols for older adults. Self-management of chronic diseases via mHealth training requires careful consideration of the complex nature of human behavior, emotional responses, and familial influences. Therefore, integration of a theoretical, clinical, and technical approach is necessary for the successful development and implementation of an mHealth training program that targets older adults with chronic diseases in a community setting.

Project description:BackgroundImpaired balance leading to falls is common in the older adults, and there is strong evidence that balance training reduces falls and increases independence. Reduced resources in health care will result in fewer people getting help with rehabilitation training. In this regard, the new technology augmented reality (AR) could be helpful. With AR, the older adults can receive help with instructions and get feedback on their progression in balance training. The purpose of this pilot study was to examine the feasibility of using AR-based visual-interactive tools in balance training of the older adults.MethodsSeven older adults (66-88 years old) with impaired balance trained under supervision of a physiotherapist twice a week for six weeks using AR-based visual-interactive guidance, which was facilitated through a Microsoft HoloLens holographic display. Afterwards, participants and physiotherapists were interviewed about the new technology and their experience of the training. Also, fear of falling and balance ability were measured before and after training.ResultsFive participants experienced the new technology as positive in terms of increased motivation and feedback. Experiences were mixed regarding the physical and technical aspects of the HoloLens and the design of the HoloLens application. Participants also described issues that needed to be further improved, for example, the training program was difficult and monotonous. Further, the HoloLens hardware was felt to be heavy, the application's menu was difficult to control with different hand manoeuvres, and the calibration took a long time. Suggestions for improvements were described. Results of the balance tests and self-assessment instruments indicated no improvements in balance performance after AR training.ConclusionsThe study showed that training with the new technology is, to some extent, feasible for the older adults, but needs further development. Also, the technology seemed to stimulate increased motivation, which is a prerequisite for adherence to training. However, the new technology and training requires further development and testing in a larger context.

Project description:BackgroundMore people are living longer lives leading to a growth in the population of older adults, many of whom have comorbidities and low levels of physical function. Physical activity in later life can prevent or delay age-related disability. Identifying a cost-effective means of increasing physical activity in older adults therefore remains an important public health priority.Physical Activity Facilitation (PAF) is an intervention shown to increase physical activity in adults with depression. The PAF model was modified for a population of older adults at risk of disability. This study aimed to assess the feasibility of undertaking a definitive RCT of the PAF intervention in the target population.MethodsA pilot randomised controlled trial (RCT) was delivered through primary care. Patients at risk of disability and who were not meeting recommended levels of physical activity were recruited through postal invitation and direct approach in the practice waiting room. Those meeting eligibility criteria were enrolled and randomised at a 2:1 ratio to the PAF intervention and control. Behaviour change techniques were used by facilitators with participants over the telephone and face-to-face for 6 months. Outcome measures including physical function, physical activity, depression, social support, and quality of life were collected at baseline and at 6 months.ResultsA high proportion of patients responded to the initial invitation (68%), yet many were ineligible due to high levels of self-reported physical activity and baseline physical function. Fifty-one participants were recruited to the trial, with an average age of 74 years (range 65-89), and there were high rates of adherence and retention to the study (94% follow-up at 6 months). The majority of outcome data collected from participants was complete; however, the validated scale used to measure self-reported physical activity was associated with high levels of missing data.ConclusionsThe findings of this pilot RCT suggest that it is feasible to deliver a definitive RCT of the PAF intervention in this population. Further work is required to improve the efficiency of recruitment and to minimise missing data from self-reported physical activity measures.Trial registrationCurrent controlled trials ISRCTN80470273. Registered 25 October 2013.

Project description:BACKGROUND:Older adults living in nursing homes spend the majority of their time inactive. The associated levels of chronic disease place an increasing burden on healthcare systems. Physical activity (PA) interventions delivered through exercise classes may be resource-intensive and require specialist staff. The aim of this study is to explore the feasibility and acceptability of a PA programme embedded into the daily lives of older adults living in nursing homes and to examine the preliminary effects of this on physical mobility and quality of life. METHODS:A randomised controlled pilot feasibility study, including embedded qualitative and economic components will be carried out. Two randomly selected nursing homes will take part in the study; participants (n?=?20) in one nursing home will receive a three-month PA intervention and participants (n?=?20) in the other will be a usual care control. Nursing home staff will be provided with training and support to monitor participants PA programmes. Feasibility data will be collected on recruitment, randomisation, assessment and intervention procedures. Criteria for progression of the pilot feasibility study to a definitive trial will be specified. The Timed Up and Go test, Nottingham Health Profile, 10-Metre Walk test, the Investigating Choice Experiments for the Preferences of Older People Capability index and the Bangor Goal Setting Interview will be assessed at baseline, three-month and 12-month follow-up. Between-group and within-individual effects will be estimated using appropriate linear mixed models. Semi-structured interviews will be conducted with staff and participants of the intervention group within one month after the intervention to explore the feasibility and acceptability of the programme. A subset of control participants will be interviewed to describe usual care. Economic data will be collected to examine costs of the intervention in comparison with costs in the control group. DISCUSSION:The findings will facilitate refinement of the PA programme and development of a clear protocol for subsequent evaluation of the PA intervention in a definitive randomised controlled trial. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03484715 . Registered on 30 March 2018.

Project description:BackgroundOlder adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. This paper reports a protocol designed to evaluate the feasibility of conducting a three arm randomised controlled trial (RCT) within the ED setting and in the patient's home. The interventions are comprehensive geriatric assessment (CGA), ED PLUS and usual care.MethodsThe ED PLUS pilot trial is designed as a feasibility RCT conducted in the ED and Acute Medical Assessment Unit of a university teaching hospital in the mid-west region of Ireland. We aim to recruit 30 patients, aged 65 years and over presenting to the ED with undifferentiated medical complaints and discharged within 72 h of index visit. Patients will be randomised by a computer in a ratio of 1:1:1 to deliver usual care, CGA or ED PLUS during a 6-month study period. A randomised algorithm is used to perform randomization. CGA will include a medical assessment, medication review, nursing assessment, falls assessment, assessment of mobility and stairs, transfers, personal care, activities of daily living (ADLs), social supports and baseline cognition. ED PLUS, a physiotherapist led, multidisciplinary intervention, aims to bridge the transition of care between the index visit to the ED and the community by initiating a CGA intervention in the ED and implementing a 6-week follow-up self-management programme in the patient's own home following discharge from the ED. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively.DiscussionRising ED visits and an ageing population with chronic health issues render ED interventions to reduce adverse outcomes in older adults a research priority. This feasibility RCT will generate data and experience to inform the conduct and delivery of a definite RCT.Trial registrationThe trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT049836020 .

Project description:BackgroundSwallowing difficulties (ie, dysphagia) are common among older adults, with a 13% to 54% prevalence. Adequate interventions to improve the swallowing function of older adults would reduce morbidity and enhance health-related quality of life outcomes. Mobile health (mHealth) apps may help alleviate dysphagia symptoms by providing programs that maximize the intensity and frequency of training without requiring high costs or regular clinic visits.ObjectiveThe aim of this pilot study was to assess the usability of swallowing training apps by quantitatively and qualitatively evaluating older adults' self-reported data, taking into consideration their educational levels and exposure to mobile technology. We conducted surveys and brief interviews while the participants used a swallowing intervention app we developed. We subsequently identified and resolved individual-specific usability issues to improve future implementation of the app protocol for older persons with swallowing difficulties.MethodsA total of 11 participants (10 women, 91%; mean age 75.7 years, SD 3.93) from two district-run senior welfare centers took part in this study. The participants were divided into a high-potential group and a low-potential group based on their total number of years of education and smart device usage. To investigate the usability of the app twice (ie, in the second week of the intervention and the postintervention stage), we used mixed methods consisting of both quantitative approaches, namely the System Usability Scale (SUS) and modified Computer Self-Efficacy Scale (mCSES) surveys, and qualitative approaches (ie, interviews).ResultsThe quantitative results of the SUS and mCSES surveys revealed that the high-potential group was more inclined to adopt and learn new technology than the low-potential group. Specifically, within the high-potential group, a Wilcoxon signed-rank test indicated that the postintervention mCSES scores (median 65.50) were significantly higher than those in the second week of intervention (median 54.00; z=-2.023, P=.04). Additionally, the usability scores in the low-potential group were within the "marginal acceptability" range even after completion of an 8-week intervention program. Qualitative analyses via semi-structured interviews yielded promising outcomes regarding app acceptability, training program utilization, emotional responses, and learning experience.ConclusionsTo the best of the authors' knowledge, this usability and feasibility study is the first report of a swallowing training app designed to improve the swallowing function of older adults. Future research should consider several issues, such as user characteristics, pretraining education, and the intensity and innate characteristics of the intervention program.

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Feasibility of a 6-month pilot randomised controlled trial of resistance training on cognition and brain health in Canadian older adults at-risk for diabetes: study protocol.

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Feasibility of a 6-month pilot randomised controlled trial of resistance training on cognition and brain health in Canadian older adults at-risk for diabetes: study protocol.

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