Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

Study Overview
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Brief Summary
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The study will implement and test a unique Virtual Reality Cognitive Training (VRCT) combined with concurrent cycling on a recumbent stationary cycle, also known as exergame that seamlessly integrates specific cognitive tasks into a virtual environment and is synchronized with cycling to promote cognition.

Detailed Description
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The proposed project will implement and test a unique Virtual Reality Cognitive Training (VRCT) combined with concurrent cycling on a recumbent stationary cycle, also known as exergame that seamlessly integrates specific cognitive tasks into a virtual environment and is synchronized with cycling to promote cognition. Cycling through an interesting virtual environment will motivate and engage the older adult to participate in the exercise, and VRCT could augment cycling's effects on cognition. The purpose of this project is to demonstrate the feasibility and efficacy of the exergame intervention on cognition through two phases. In Phase I, a prototype of the VRCT exergame will be developed, followed by a feasibility testing using a single-group mixed methods design. In Phase II a more fully-featured version of the VRCT exergame will be developed followed by a an RCT which will randomize subjects on a 2:1:1 allocation ratio to 3 parallel groups (exergame:cycling only:attention control). Mixed methods will be used to assess outcomes in both phases.

Official Title
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Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults

Conditions
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Preclinical Alzheimer's Disease

Intervention / Treatment
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* Behavioral: Exergame


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cognitive complaint (defined as answering yes to the question Do you feel that your memory or thinking skills have gotten worse recently?) Not engaging in aerobic exercise or cognitive training >2 days/week, 30 minutes a session in the past 3 months; Age 65 years and older Exclusion Criteria: Resting heart rate > 100 or < 50 beats/min; Dementia (self-report, diagnosis, or scoring <18 on the modified Telephone Interview for Cognitive Status; Neurological or major psychiatric disorder since memory problem; Significant diseases, symptoms, or other factors that make exercise unsafe Current enrollment in another intervention study

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Cognitive Training<br>Exergame to stimulate cognition | Behavioral: Exergame<br>* Participants will take part in the exergame, 3 times a week for a month. The session will start for 30-35 minutes of cycling on recumbent stationary cycles in session 1 and progress to moderate intensity for 50 minutes a session. Participants will do warm-up and cool-down activities before and after cycling. While cycling, participants will be playing virtual reality based games. An exercise interventionist will supervise the sessions and monitor participant's conditions and responses to ensure safety.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the exergame development | development of the exergame prototype by 3 months | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycling adherence rate | ≥70% subjects adhere to the cycling dose | 3-6 months | 
| VCRT adherence rate | ≥70% subjects adhere to the cognitive training dose | 3-6 months | 
| Usability and satisfaction with the exergame | Participants report acceptable usability and satisfaction with the exergame | 3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjective memory complaint