Clinical trial NCT06340659: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)
Official title: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: At Risk for AD-dementia, With Subjective Cognitive Decline
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study will use a single-blind, randomized trial will randomize 104 community-dwelling older adults to one of two arms for 3 months: home-based (asynchronous) Exergame (HbExergame) or home-based asynchronous aerobic exercise (HbAEx). Randomization will allocate subjects on a 1:1 allocation ratio within each age stratum (65-74 and ≥75) in random blocks of 8 or 4
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: fluid cognition (global cognition)
timeFrame: 12 weeks
Secondary outcomes:
measure: Aerobic fitness
timeFrame: 12 weeks
measure: Neuroprotective biomarkers and ApoE status.
timeFrame: 12 weeks
measure: Exergame-specific usability and satisfaction
timeFrame: 12 weeks
measure: SCD Symptoms
timeFrame: 12 weeks
measure: Anxiety Symptoms
timeFrame: 12 weeks
measure: Depressive Symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: