Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

NCT ID: NCT02963415

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-03-31

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.

Conditions

Preclinical Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Virtual Reality Cognitive Training

Exergame to stimulate cognition

Group Type: EXPERIMENTAL

Exergame

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fang Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1610M98324

Identifier Type: -

Identifier Source: org_study_id