Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

Not Applicable

Completed

• Conditions: Preclinical Alzheimer's Disease
• Interventions: Behavioral: Exergame

• Registration Number: NCT02963415
• Lead Sponsor: University of Minnesota

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-15
• Study Start: 2019-03-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

1. Cognitive complaint (defined as answering yes to the question "Do you feel that your memory or thinking skills have gotten worse recently?)
2. Not engaging in aerobic exercise or cognitive training >2 days/week, 30 minutes a session in the past 3 months;
3. Age 65 years and older

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Exclusion Criteria

1. Resting heart rate > 100 or < 50 beats/min;
2. Dementia (self-report, diagnosis, or scoring <18 on the modified Telephone Interview for Cognitive Status;
3. Neurological or major psychiatric disorder since memory problem;
4. Significant diseases, symptoms, or other factors that make exercise unsafe
5. Current enrollment in another intervention study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality Cognitive Training	Exergame	Exergame to stimulate cognition

Primary Outcome Measures

Name	Time	Method
Feasibility of the exergame development	Baseline to 3 months	development of the exergame prototype by 3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States