NCT02963415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
2.3 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

3.1 years

First QC Date

November 8, 2016

Last Update Submit

June 6, 2022

Conditions

Keywords

Subjective memory complaint

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the exergame development

    development of the exergame prototype by 3 months

    Baseline to 3 months

Secondary Outcomes (3)

  • Cycling adherence rate

    3-6 months

  • VCRT adherence rate

    3-6 months

  • Usability and satisfaction with the exergame

    3-6 months

Study Arms (1)

Virtual Reality Cognitive Training

EXPERIMENTAL

Exergame to stimulate cognition

Behavioral: Exergame

Interventions

ExergameBEHAVIORAL

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.

Virtual Reality Cognitive Training

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Exergaming

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fang Yu, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 15, 2016

Study Start

March 1, 2019

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations