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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311736
Recruitment Status : Unknown
Verified March 2020 by Moai Technologies LLC.
Recruitment status was:  Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
University of Minnesota
Information provided by (Responsible Party):
Moai Technologies LLC

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Exercise Training Behavioral: Exergame Behavioral: Cycling Behavioral: Stretching Not Applicable

Detailed Description:

A treatment that delays the onset of Alzheimer's disease (AD) by five years could be hugely cost-saving at an estimated $89 billion in 2030. However, nearly all (99.6%) drug trials for AD have failed, and no drugs can yet prevent, cure, or even slow AD. This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression. Aerobic exercise and cognitive training are two such promising interventions.

Aerobic exercise and cognitive training are 2 promising interventions for preventing AD. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective neural function intensively. Hence, concurrent aerobic exercise and cognitive training may very well have an additive or synergistic effect on cognition by complementary strengthening of different neural functions because aerobic exercise and virtual reality cognitive training depend on discrete neuronal mechanisms for their therapeutic effects.

The purpose of this Phase II randomized controlled trial (RCT) is to test the efficacy and additive/synergistic effects of a 3-month combined cycling and virtual reality cognitive training intervention on cognition and relevant mechanisms (aerobic fitness, physical function), in persons with subjective cognitive decline at risk for developing AD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergame Study)
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exergame
Moderate intensity cycling only 3 times per week for 12 weeks + concurrent virtual reality cognitive training, supervised by an exercise specialist
Behavioral: Exergame
Cycling on a recumbent cycle ergometer + Virtual Reality Cognitive Training

Active Comparator: Cycling
Moderate intensity cycling only 3 times per week for 12 weeks, supervised by an exercise specialist
Behavioral: Cycling
Cycling on a recumbent cycle ergometer

Sham Comparator: Stretching
Stretching 3 times per week for 12 weeks, supervised by a therapist
Behavioral: Stretching
Stretching exercises




Primary Outcome Measures :
  1. Episodic Memory [ Time Frame: change from baseline to 3 months ]
    change in composite scores of episodic memory. Score are automatically computed by NIH Toolbox App,Scoring Process: Item Response Theory (IRT) is used to score the TPVT. A score known as a theta score is calculated for each participant; it represents the relative overall ability or performance of the participant. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one.


Secondary Outcome Measures :
  1. Executive Function [ Time Frame: change from baseline to 3 months ]
    change in composite measures of executive function, Score are automatically computed by NIH Toolbox App,Scoring Process: Item Response Theory (IRT) is used to score the TPVT. A score known as a theta score is calculated for each participant; it represents the relative overall ability or performance of the participant. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one.

  2. Global Cognition [ Time Frame: change from baseline to 3 months ]
    change in composite measures of global cognition. Score are automatically computed by NIH Toolbox App,Scoring Process: Item Response Theory (IRT) is used to score the TPVT. A score known as a theta score is calculated for each participant; it represents the relative overall ability or performance of the participant. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one.

  3. Aerobic Fitness [ Time Frame: change from baseline to 3 months ]
    change in 10 meter shuttle walk test


Other Outcome Measures:
  1. Physical Function [ Time Frame: change from baseline to 3 months ]
    change in 6 minute walk test

  2. Physical Function [ Time Frame: change from baseline to 3 month ]
    change in Short Physical Performance Battery Score-Balance

  3. Physical Function [ Time Frame: change from baseline to 3 months ]
    change in short physical performance battery score-Sit to stand

  4. Physical Function [ Time Frame: change from baseline to 3 months ]
    change in short physical performance battery score-4 meter Gait speed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311736


Contacts
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Contact: Russell L Spafford, MS 612-626-6045 spaff010@umn.edu
Contact: Sue Greimel, MS 612-626-9490 moone104@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Russell L Spafford, MS    612-626-6045    spaff010@umn.edu   
Contact: Dereck L Salisbury, PhD    612-625-9308    salis048@umn.edu   
Principal Investigator: Dereck L Salisbury, PhD         
Principal Investigator: Tom Plocher, PhD         
Sponsors and Collaborators
Moai Technologies LLC
University of Minnesota
Investigators
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Principal Investigator: Dereck L Salisbury, PhD salis048@umn.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Moai Technologies LLC
ClinicalTrials.gov Identifier: NCT04311736    
Other Study ID Numbers: EXERGAMES2
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moai Technologies LLC:
mild cognitive impairment
cognitive decline
aerobic exercise
physical exercise
exercise training
cognitive exercise
cognitive games
virtual reality
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders