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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
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preclinical Alzheimer's Disease focused on measuring Subjective memory complaint

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
November 8, 2016
Last Updated
June 6, 2022
Sponsor
University of Minnesota
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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

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Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

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