Recruiting

Aerobic Exercise & Cognitive Training

Sponsor:

Moai Technologies LLC

Code:

NCT04311736

Conditions

Mild Cognitive Impairment

Exercise Training

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Exergame

Cycling

Stretching

Study Details

Brief summary:

In this research, a unique "Exergame" has been developed and is being tested. The Exergame consists of unique Virtual Reality Cognitive Training (VRCT) games combined with concurrent cycling on a recumbent stationary cycle. The Exergame 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. A further innovation is that the Exergame has been developed as both an Apple TV and iPAD application, making it widely accessible and available. It will provide a low-cost VRCT Exergame option that currently does not exist, one that is affordable and compatible with almost any stationary cycle. This project is significant because treatment that delays the onset of Alzheimer's Disease (AD) by five years could save the U.S. economy an estimated $89 billion by 2030 and no drugs can yet prevent, cure, or even slow AD. Aerobic exercise and cognitive training are two such promising interventions. Emerging mechanistic studies further suggest that the two interventions together may have a synergistic, superior cognitive effect than either intervention alone. The purpose of this project is to demonstrate the feasibility and efficacy of the Exergame intervention on cognition. An RCT is planned in which subjects are randomized 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.

Conditions

Mild Cognitive Impairment

Exercise Training

Study ID

NCT04311736

Start date

Oct 1, 2019

Status verified date

Mar, 2020

Completion date

Oct 1, 2021

Anticipated

Primary completion date

Oct 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Cognitive complaint (defines as answering yes to the question "Do you feel that your memory or thinking skills have gotten worse recently within the last 2 years?");
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;
4. Written consent.
5. Medical clearance to participate in a supervised exercise program

Exclusion Criteria:

1. Resting heart rate > 100 or <50 beats/min with symptoms;
2. Dementia or mild cognitive impairment (self-report, diagnosis, or scoring <26 on the Telephone Interview for Cognitive Status;
3. Evidence that cognitive decline or memory complaints were caused by underlying neurological or psychiatric disorder or chemical dependency as determined by primary health care provider;
4. Current enrollment in another intervention study;
5. ACSM contraindications to exercise or other factors that make exercise impossible or unsafe.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Exergame

Moderate intensity cycling only 3 times per week for 12 weeks + concurrent virtual reality cognitive training, supervised by an exercise specialist

active comparator: Cycling

Moderate intensity cycling only 3 times per week for 12 weeks, supervised by an exercise specialist

sham comparator: Stretching

Stretching 3 times per week for 12 weeks, supervised by a therapist

Interventions

Exergame

Cycling on a recumbent cycle ergometer + Virtual Reality Cognitive Training

Cycling

Cycling on a recumbent cycle ergometer

Stretching

Stretching exercises

Primary outcome measure

  • Episodic Memory [ Time Frame: change from baseline to 3 months ]

Central Contacts and Locations

Central contacts

Russell L Spafford, MS

612-626-6045spaff010@umn.edu

Sue Greimel, MS

612-626-9490moone104@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Russell L Spafford, MS

612-626-6045spaff010@umn.edu

Dereck L Salisbury, PhD

612-625-9308salis048@umn.edu

Principal Investigator:

Dereck L Salisbury, PhD

More Information

Sponsor

Moai Technologies LLC

Last update posted

Mar 17, 2020

Last verified

Mar, 2020

Keywords

  • mild cognitive impairment
  • cognitive decline
  • aerobic exercise
  • physical exercise
  • exercise training
  • cognitive exercise
  • cognitive games
  • virtual reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Moai Technologies LLC on 2020-03-17.