Concurrent Aerobic Exercise and Virtual Reality Cognitive Training (VRCT)

• ClinicalTrials.gov Identifier: NCT02963415
• Recruitment Status: Completed
• First Posted: November 15, 2016
• Last Update Posted: June 8, 2022
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preclinical Alzheimer's Disease	Behavioral: Exergame	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: March 31, 2022
• Actual Study Completion Date: March 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of the exergame development [ Time Frame: Baseline to 3 months ]
   development of the exergame prototype by 3 months

Secondary Outcome Measures :

1. Cycling adherence rate [ Time Frame: 3-6 months ]
   ≥70% subjects adhere to the cycling dose
2. VCRT adherence rate [ Time Frame: 3-6 months ]
   ≥70% subjects adhere to the cognitive training dose
3. Usability and satisfaction with the exergame [ Time Frame: 3-6 months ]
   Participants report acceptable usability and satisfaction with the exergame

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Fang Yu, PhD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02963415
• Other Study ID Numbers: 1610M98324
• First Posted: November 15, 2016
• Last Update Posted: June 8, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

Subjective memory complaint

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders