Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)

NCT ID: NCT06340659

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-14
• Study Completion Date: 2026-09-30

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.

Conditions

At Risk for AD-dementia, With Subjective Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Subjects randomized to HbAEX

Group Type: EXPERIMENTAL

HbAEx

Intervention Type: BEHAVIORAL

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.

Group 2

Subjects randomized to HbExergame

Group Type: EXPERIMENTAL

HbExergame

Intervention Type: BEHAVIORAL

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.

Interventions

HbAEx

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.

Intervention Type: BEHAVIORAL

HbExergame

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dereck Salisbury

Role: CONTACT

salis048@umn.edu

612-625-9308

Facility Contacts

Dereck Salisbury, PhD

Role: primary

salis048@umn.edu

612-625-9308

Other Identifiers

AE and CT

Identifier Type: -

Identifier Source: org_study_id