Efficacy of simultaneous aerobic exercise and cognitive training in persons with subjective cognitive decline residing in Minnesota: study protocol for randomized controlled trial of the Exergames TeleHealth Study

Exergaming is a cost-effective strategy aimed to preserve the daily living performance and cognitive well-being of individuals in the early stages of Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD). Recently, advancements in technology have allowed for home-based (asynchronous) telerehabilitation interventions such as exercise training to be utilized as a supplement or replacement to conventional, in person or synchronous rehabilitation programs. Although telerehabilitation is a growing form of therapy, it has yet to be studied in the form of physical-cognitive exergames in persons at risk for AD/ADRD (i.e., subjective cognitive decline [SCD]). In order to expand our impact, reach, and marketability of our exergame (BrainFitRx) and combat these participation barriers, the sustainability and efficacy of Exergames in a home-based environment needs to be assessed. The purpose of this single-blinded, 2-parallel group randomized controlled trial is to (1) test the usability and user satisfaction of BrainFitRx in older adults with SCD and (2) test the efficacy of the BrainFitRx on cognition, CRF, and neuroprotective and neuro/systemic inflammatory biomarkers in older adults with SCD. The superiority randomized clinical trial will randomize 104 community-dwelling older adults residing in a Midwest metropolitan region, at risk of AD/ADRD (cognitively intact, subjective cognitive decline) to one of two groups for 3 months: home-based (asynchronous telerehabilitation) BrainFitRx or home-based (asynchronous telerehabilitation) aerobic exercise. Randomization will allocate subjects on a 1:1 allocation ratio within each age stratum (65–74 years and ≥75 years), using permuted blocks of 8 and 4. Participants will be recruited primarily by the study coordinator and other research staff. Efficacy-focused data will be analyzed using analysis of covariance following intention-to-treat. Adverse events will be categorized (expected and unexpected) and graded (severity, study-related/unrelated) by study investigators. This study will test the synergistic effects of a home-based, asynchronously delivered BrainFitRx on cognition, CRF, and neuroprotective/inflammatory biomarkers. It has the potential to advance prevention research for AD/ADRD by providing effect-size estimates for future trials. Clinicaltrials.gov NCT06340659. Registered on 7/8/2024; date of first planned enrollment: 8/14/24. Trial status: active, not recruiting. https://www.clinicaltrials.gov/study/NCT06340659