scholarly journals 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

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032047
Author(s):  
Joyla A Furlano ◽  
Lindsay S Nagamatsu

IntroductionType 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 analysisWe 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 disseminationOur 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 numberNCT03254381

2021 ◽  
Author(s):  
Ruth McLaren ◽  
Paul F. Smith ◽  
Sue Lord ◽  
Preet Kamal Kaur ◽  
Yiwen Zheng ◽  
...  

UNSTRUCTURED Background: Reduced mobility and falls are common in older adults. Balance retraining programmes are effective in reducing falls and improving balance and mobility. Noisy galvanic stimulation (nGVS) is a low level electrical stimulation used to reduce the threshold for firing of vestibular neurons via a mechanism of stochastic resonance. We hypothesise that nGVS will enhance the effects of balance retraining in older adults at risk of falls. Methods: This 3- armed randomised controlled trial assesses the feasibility of augmenting balance retraining with nGVS. Community dwelling older adults at risk of falling will be randomly assigned to either an nGVS plus balance programme (nGVS group), sham plus balance programme (sham group) or a no treatment group (Control). Participants will attend the exercise group twice a week for 8 weeks with assessment of balance and gait pre-treatment, post-treatment and at 3-months post-intervention. Primary outcome measures include postural sway, measured by Centre of Pressure (COP) velocity, area and root mean square and gait parameters of speed, step width, step variability and double support time. Spatial memory will also be measured using the Triangle Completion and 4 Mountains Tests. Discussion: This study will evaluate the feasibility of using nGVS alongside balance retraining in older adults at risk of falls and will inform the design of a fully powered randomised controlled trial. Trial registration: This trial has been prospectively registered with the Australia New Zealand Clinical Trials Registry (ACTRN12620001172998) and has a UTN of U1111-1241-2231.


2016 ◽  
Vol 12 ◽  
pp. P422-P423
Author(s):  
Shannon Lee Webb ◽  
Kaarin J. Anstey ◽  
Nicolas Cherbuin ◽  
Lauren Bartsch ◽  
George Rebok ◽  
...  

2019 ◽  
Vol 22 (11) ◽  
pp. 1226-1231 ◽  
Author(s):  
Kieran J. Marston ◽  
Jeremiah J. Peiffer ◽  
Stephanie R. Rainey-Smith ◽  
Nicole Gordon ◽  
Shaun Y. Teo ◽  
...  

2021 ◽  
Author(s):  
Kate Loveys ◽  
Mark Sagar ◽  
Isabella Pickering ◽  
Elizabeth Broadbent

BACKGROUND Loneliness is a growing public health issue that has been exacerbated in vulnerable groups during the COVID-19 pandemic. Computer agents are capable of delivering psychological therapies through the internet, however, there is little research on their acceptability to date. OBJECTIVE The objectives of this study were to evaluate: (1) the feasibility and acceptability of a remote loneliness and stress intervention with digital human delivery to at-risk adults; and (2) the feasibility of the trial methods in preparation for a randomised controlled trial. METHODS A parallel, randomised pilot trial with a mixed design was conducted. Participants were adults aged 18–69 years with an underlying medical condition, or aged 70 years or older with a >24 MMSE score (i.e., at greater risk of developing severe COVID-19). Participants took part from their place of residence (20= independent living retirement village, 7= community dwelling, 3= nursing home). Participants were randomly allocated to the intervention or waitlist control group, who received the intervention one week later. The intervention involved completing cognitive behavioural (e.g., psychoeducation on stress awareness, deep breathing) and positive psychology exercises with a digital human facilitator on a website for at least 15-minutes per day over one week. The exercises used evidence-based strategies to improve loneliness, stress, and psychological well-being. Feasibility was evaluated using dropout rates and behavioural observation data. Acceptability was evaluated using behavioural engagement data, the Friendship Questionnaire (adapted), self-report items and qualitative questions. Psychological outcomes were measured to evaluate feasibility of trial methods and included loneliness (UCLA Loneliness Scale), stress (Perceived Stress Scale), COVID-19 distress, well-being (Flourishing Scale), and affect (Scale of Positive and Negative Experiences). RESULTS 30 participants (15 per group) were recruited. Participants were 22 older adults, and 8 younger adults with a health condition. 6 participants dropped out of the study. 24 participants’ data were analysed (12= intervention group; 12= waitlist group). The digital human intervention and trial methods were generally found to be feasible and acceptable in younger and older adults living independently. Slow internet speed reduced intervention feasibility for some participants. Suggestions for improvement included: additional content, tailoring to the population, and changes for the digital human’s design. The intervention and trial methods were less feasible to nursing home residents who required caregiver assistance. CONCLUSIONS The digital human was a feasible and acceptable way of delivering a remote loneliness and stress intervention to at-risk adults during the COVID-19 pandemic. The intervention and trial methods were most feasible for people living independently. Support was found for further testing of digital humans to deliver remote psychological interventions. Findings will inform expansion of intervention content and the design of a randomised controlled trial to evaluate intervention effectiveness. CLINICALTRIAL Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000786998


2019 ◽  
Vol 26 (4) ◽  
pp. 370-377
Author(s):  
Hilaire J Thompson ◽  
Ellen McGough ◽  
George Demiris

BackgroundThe primary cause of traumatic injury in older adults is fall. Recent reports suggest that cognitive function contributes significantly to fall risk. Therefore, by targeting cognitive function for intervention, we could potentially reduce the incidence of fall and injury.Primary objectiveTo explore the effectiveness of a 16-week cognitive training (CT) intervention to reduce risk and incidence of fall in community-dwelling older adults at risk for fall.OutcomesPrimary outcome is number of falls over a 16-week period (ascertained by fall calendar method). Secondary outcomes include: change fall risk as indicated by improvement in 10 m walk and 90 s balance tests.Design/methodsThe design is a two-group randomised controlled trial. Eligible participants are older adults (aged 65–85) residing in the community who are at risk for fall based on physical performance testing. Following completion of 1-week run-in phase, participants are randomly allocated (1:2) to either a group that is assigned to attention control or to the group that receives CT intervention for a total of 16 weeks. Participants are followed for an additional 4 weeks after intervention. Mann-Whitney U test and Student’s t-test will be used to examine between-group differences using intention-to-treat analyses.DiscussionLimited evidence supports the potential of CT to improve cognition and gait, but no published study has evaluated whether such an intervention would reduce incidence of fall. The present trial is designed to provide initial answers to this question. CT may also improve functioning important in other activities (eg, driving), reducing overall risk of injury in elders.Trial registration numberNCT03190460.


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