Clinical trial NCT02963415: Concurrent Aerobic Exercise and Virtual Reality Cognitive Training
Official title: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preclinical Alzheimer's Disease
Keywords: Subjective memory complaint
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 39
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of the exergame development
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Cycling adherence rate
timeFrame: 3-6 months
measure: VCRT adherence rate
timeFrame: 3-6 months
measure: Usability and satisfaction with the exergame
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Fang Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References: