Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)
University of Minnesota
104 participants
Aug 14, 2024
INTERVENTIONAL
Conditions
Summary
Significance of Research Question/Purpose: Subjective cognitive decline (SCD) is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 11.2% in adults over the age of 45, with incidence increasing with greater age. Furthermore, population-based studies suggest that between 50% and 80% of older individuals (aged 70 years and older) who perform normally on cognitive tests, report some form of perceived decline in cognitive functioning when asked. The SCD state is unique as this population is more likely than their healthy peers to present with AD biomarkers such as neurodegeneration and amyloid burden, and therefore represents probable preclinical AD relative to other causes of SCD. Likewise, growing evidence suggests that a significant proportion of those adults are subsequently found to develop MCI, or AD, following the classic SCD-MCI-AD trajectory, with SCD increasing MCI risk 1.5-3 fold. Preventing Alzheimer's disease (AD) is arguably the most important approach to address the dementia epidemic worldwide because 99.6% of drug trials failed and no drugs can yet prevent, cure, or even slow AD. A treatment that delays the onset of AD by five years could save $89 billion in 2030.This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression. This study will use a randomized, 2-parallel group, trial design that is guided by the Consolidated Standards of Reporting Trials (CONSORT)and the SPIRIT checklist. We will randomize 104 community-dwelling older adults to one of two arms for 3 months: home-based (asynchronous telerehabilitation) Exergame (HbExergame) or home-based (asynchronous telerehabilitation) aerobic exercise (HbAEx). Randomization will allocate subjects on a 1:1 allocation ratio within each age stratum (65-74 and \>75), and will use permuted blocks of 8 and 4. We do not expect equal numbers of subjects in each age stratum, but want to balance the groups for each age. Investigators will be blinded to group assignment. All participants will be blinded to study aims and reminded as needed not to discuss their experiences with outcome assessors. Outcome assessors (also blinded to group allocations) will measure: 1) feasibility (attendance, adherence to exercise dose, systems usability scale), 2) preliminary cognition: fluid cognition \[primary outcome\], attention, episodic memory, and processing speed \[secondary outcomes\] using the NIH Toolbox cognition battery and aerobic fitness \[VO2peak and 6-minute walk distance\], and 3) blood neurotrophic biomarkers.
Eligibility
Inclusion Criteria5
- Cognitive complaint (defined as answering yes to the questions's "Do you perceive memory or cognitve difficulties?" and "In the last two years, has your cognition or memory declined?";
- Montreal Cognitive Assessement (MoCA) 26 or greater
- Age 65 years and older;
- English-speaking;
- Without ACSM contraindication to exercise
Exclusion Criteria3
- Dementia or mild cognitive impairment diagnosis;
- Neurological or major psychiatric disorder, alcohol/chemical dependency or recent medical condition (anethesia COVID-19 \["brain fog"\]) likely causing cognitive impairment;
- Current enrollment in another intervention study
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants will have a 1-week (3 session) on-boarding period where study interventionists will deliver all necessary equipment (bike, pulse oximeters, etc.) to the participants' home, review the AEx program and prescription, and supervise the first 3 sessions to ensure participant understanding and fidelity of the AEx program. Thereafter, the remaining 33 sessions will be conducted by the participant without the direct supervision (asynchronous telerehabilitation) of the study interventionists. Subjects will cycle on recumbent stationary cycles at moderate-vigorous intensity individualized as 50-70% of heart rate reserve (HRR) and/or 11-14 on Borg Category Ratio-15 Rating of Perceived Exertion (RPE) Scale, for 30-50 minutes per session. Following the completion of each session, during the check-in meeting with the participant, the study interventionist will gather information from the participant (including HR and RPE) for dose quantification.
Participants will cycle as described in the HbAEx protocol while engaging in cognitive training for the duration of cycling. Cognitive training will include 20 levels of difficulty with 8-10 task scenarios in the context of three virtual worlds (environments. In each of the environments, the participant must follow directions and navigate to a destination where the scenario (cognitive task) will be performed. The game will inform the participant of the assigned task and, automatically, determine and inform the participant of the fastest route from the starting point to the scenario destination where the task will be performed. The participant will be required to remember the assigned task, follow the directions and navigate to the destination, and then remember what action is required to complete the task. A scenario-specific cognitive task will be triggered once the destination has been reached. The cycling and cognitive tasks will be completed throughout the sessions.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06340659