Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

Preclinical Alzheimer's Disease Clinical Trial

— VRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963415
• Other study ID #: 1610M98324
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Preclinical Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the exergame development	development of the exergame prototype by 3 months	Baseline to 3 months
Secondary	Cycling adherence rate	=70% subjects adhere to the cycling dose	3-6 months
Secondary	VCRT adherence rate	=70% subjects adhere to the cognitive training dose	3-6 months
Secondary	Usability and satisfaction with the exergame	Participants report acceptable usability and satisfaction with the exergame	3-6 months