Concurrent Aerobic Exercise and Virtual Reality Cognitive Training (VRCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Preclinical Alzheimer's Disease
• Intervention / Treatment: Behavioral: Exergame

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Reality Cognitive Training; Exergame to stimulate cognition

Behavioral: Exergame; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Fang Yu, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Subjective memory complaint
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 1610M98324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No