Implementing an Online Virtual Falls Prevention Intervention During a Public Health Pandemic for Older Adults with Mild Cognitive Impairment: A Feasibility Trial.
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ABSTRACT: Purpose
This study evaluates the feasibility of delivering a virtual (online) falls prevention intervention for older adults with mild cognitive impairment (MCI).Methods
Community-dwelling older adults with MCI (mean age = 76.2 years, 72% women) were randomized to either a Tai Ji Quan (n = 15) or stretching group (n = 15) and participated in 60-minute virtual exercise sessions, via Zoom, twice weekly for 24 weeks. The primary outcome was the incidence of falls. Secondary outcomes were the number of fallers and changes from baseline in the 4-Stage Balance Test, 30-second chair stands, and Timed Up and Go Test under both single- and dual-task conditions.Results
The intervention was implemented with good fidelity, an overall attendance rate of 79%, and 13% attrition. Compared with stretching, Tai Ji Quan did not reduce falls (incidence rate ratio = 0.58; 95% confidence interval [CI], 0.32 to 1.03) or the number of fallers (relative risk ratio = 0.75; 95% CI, 0.46 to 1.22) at week 24. The Tai Ji Quan group, however, performed consistently better than the stretching group in balance (between-group difference in change from baseline, 0.68 points; 95% CI, 0.12 to 1.24), 30-second chair stands (1.87 stands; 95% CI, 1.15 to 2.58), and Timed Up and Go under single-task (-1.15 seconds; 95% CI, -1.85 to -0.44) and dual-task (-2.35; 95% CI, -3.06 to -1.64) conditions. No serious intervention-related adverse events were observed.Conclusion
Findings from this study suggest the feasibility, with respect to intervention fidelity, compliance, and potential efficacy, of implementing an at-home, virtual, interactive Tai Ji Quan program, delivered in real-time, as a potential balance training and falls prevention intervention for older adults with MCI. The study provides preliminary data to inform future trials.
SUBMITTER: Li F
PROVIDER: S-EPMC8164667 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe conventional clinical trial design in Alzheimer's disease (AD) and AD-related disorders (ADRDs) is the parallel-group randomized controlled trial. However, in heterogeneous disorders like AD/ADRDs, this design requires large sample sizes to detect meaningful effects in an "average" patient. They are very costly and, despite many attempts, have not yielded new treatments for many years. An alternative, the multi-crossover, randomized control trial (MCRCT) is a design in which each patient serves as their own control across successive, randomized blocks of active treatment and placebo. This design overcomes many limitations of parallel-group trials, yielding an unbiased assessment of treatment effect at the individual level ("N-of-1") regardless of unique patient characteristics. The goal of the present study is to pilot a MCRCT of a potential symptomatic treatment, methylphenidate, for mild-stage AD/ADRDs, testing feasibility and compliance of participants in this design and efficacy of the drug using both standard and novel outcome measures suited for this design.MethodsTen participants with mild cognitive impairment or mild-stage dementia due to AD/ADRDs will undergo a 4-week lead-in period followed by three, month-long treatment blocks (2 weeks of treatment with methylphenidate, 2 weeks placebo in random order). This trial will be conducted entirely virtually with an optional in-person screening visit. The primary outcome of interest is feasibility as measured by compliance and retention, with secondary and exploratory outcomes including cognition as measured by neuropsychological assessment at the end of each treatment period and daily brain games played throughout the study, actigraphy, and neuropsychiatric and functional assessments.DiscussionThis pilot study will gauge the feasibility of conducting a virtual MCRCT for symptomatic treatment in early AD/ADRD. It will also compare home-based daily brain games with standard neuropsychological measures within a clinical trial for AD/ADRD. Particular attention will be paid to compliance, tolerability of drug and participation, learning effects, trends and stability of daily measures across blocks, medication carryover effects, and correlations between standard and brief daily assessments. These data will provide guidance for more efficient trial design and the use of potentially more robust, ecological outcome measures in AD/ADRD research.Trial registrationClinicalTrials.gov, NCT03811847 . Registered on 21 January 2019.
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