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Clinical Trials/NCT02963415
NCT02963415
Completed
Not Applicable

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

University of Minnesota1 site in 1 country39 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preclinical Alzheimer's Disease
Sponsor
University of Minnesota
Enrollment
39
Locations
1
Primary Endpoint
Feasibility of the exergame development
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
March 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility of the exergame development

Time Frame: Baseline to 3 months

development of the exergame prototype by 3 months

Secondary Outcomes

  • Cycling adherence rate(3-6 months)
  • Usability and satisfaction with the exergame(3-6 months)
  • VCRT adherence rate(3-6 months)

Study Sites (1)

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