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Completed

NCT Number: NCT02963415

Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

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.

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Key information

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exergame

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.

Primary outcomes

  1. Feasibility of the exergame development

    Time frame: Baseline to 3 months

    development of the exergame prototype by 3 months

Secondary outcomes

  1. Cycling adherence rate

    Time frame: 3-6 months

    ≥70% subjects adhere to the cycling dose

  2. VCRT adherence rate

    Time frame: 3-6 months

    ≥70% subjects adhere to the cognitive training dose

  3. Usability and satisfaction with the exergame

    Time frame: 3-6 months

    Participants report acceptable usability and satisfaction with the exergame

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: VRCT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2016
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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