Concurrent Aerobic Exercise and Virtual Reality Cognitive Training (VRCT)
Primary Purpose
Preclinical Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exergame
Sponsored by
About this trial
This is an interventional prevention trial for Preclinical Alzheimer's Disease focused on measuring Subjective memory complaint
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Reality Cognitive Training
Arm Description
Exergame to stimulate cognition
Outcomes
Primary Outcome Measures
Feasibility of the exergame development
development of the exergame prototype by 3 months
Secondary Outcome Measures
Cycling adherence rate
≥70% subjects adhere to the cycling dose
VCRT adherence rate
≥70% subjects adhere to the cognitive training dose
Usability and satisfaction with the exergame
Participants report acceptable usability and satisfaction with the exergame
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02963415
Brief Title
Concurrent Aerobic Exercise and Virtual Reality Cognitive Training
Acronym
VRCT
Official Title
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preclinical Alzheimer's Disease
Keywords
Subjective memory complaint
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Cognitive Training
Arm Type
Experimental
Arm Description
Exergame to stimulate cognition
Intervention Type
Behavioral
Intervention Name(s)
Exergame
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the exergame development
Description
development of the exergame prototype by 3 months
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Cycling adherence rate
Description
≥70% subjects adhere to the cycling dose
Time Frame
3-6 months
Title
VCRT adherence rate
Description
≥70% subjects adhere to the cognitive training dose
Time Frame
3-6 months
Title
Usability and satisfaction with the exergame
Description
Participants report acceptable usability and satisfaction with the exergame
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Yu, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Concurrent Aerobic Exercise and Virtual Reality Cognitive Training
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