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

• ClinicalTrials.gov Identifier: NCT04311736
• Recruitment Status: Unknown
• First Posted: March 17, 2020
• Last Update Posted: March 17, 2020
• Sponsor: Moai Technologies LLC
• Collaborator: University of Minnesota
• Information provided by (Responsible Party): Moai Technologies LLC

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Russell L Spafford, MS; 612-626-6045; spaff010@umn.edu

Contact: Sue Greimel, MS; 612-626-9490; moone104@umn.edu

Locations

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

• Principal Investigator: Dereck L Salisbury, PhD; salis048@umn.edu

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Salisbury D, Plocher T, Yu F. Efficacy of simultaneous aerobic exercise and cognitive training in subjective cognitive decline: study protocol for randomized controlled trial of the Exergames Study. Trials. 2021 Jan 6;22(1):14. doi: 10.1186/s13063-020-04950-7.

• Responsible Party: Moai Technologies LLC
• ClinicalTrials.gov Identifier: NCT04311736
• Other Study ID Numbers: EXERGAMES2
• First Posted: March 17, 2020
• Last Update Posted: March 17, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders