Mild Cognitive ImpairmentExergamesNCT04311736
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults
A study testing Exergame, Cycling and Stretching in people with Mild Cognitive Impairment and Exercise Training, run by Moai Technologies LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Exercise Training
- What is being tested?
- Exergame, Cycling and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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?");
- 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;
- Written consent.
- Medical clearance to participate in a supervised exercise program
Who cannot join
- Resting heart rate > 100 or <50 beats/min with symptoms;
- Dementia or mild cognitive impairment (self-report, diagnosis, or scoring <26 on the Telephone Interview for Cognitive Status;
- 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;
- Current enrollment in another intervention study;
- ACSM contraindications to exercise or other factors that make exercise impossible or unsafe.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Russell L Spafford, MS, 612-626-6045, spaff010@umn.edu
Dereck L Salisbury, PhD, 612-625-9308, salis048@umn.edu
About this study
Official title: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergame Study)
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Exercise Training
- Being tested
- Exergame, Cycling, Stretching
- Keywords
- mild cognitive impairment, cognitive decline, aerobic exercise, physical exercise, exercise training, cognitive exercise, cognitive games, virtual reality
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergameBehavioural
Cycling on a recumbent cycle ergometer + Virtual Reality Cognitive Training
CyclingBehavioural
Cycling on a recumbent cycle ergometer
StretchingBehavioural
Stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Exergame | Active comparator | Moderate intensity cycling only 3 times per week for 12 weeks + concurrent virtual reality cognitive training, supervised by an exercise specialist Receives: Behavioral: Exergame |
| Cycling | Active comparator | Moderate intensity cycling only 3 times per week for 12 weeks, supervised by an exercise specialist Receives: Behavioral: Cycling |
| Stretching | Sham comparator | Stretching 3 times per week for 12 weeks, supervised by a therapist Receives: Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic Memory
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.
Measured: change from baseline to 3 months
Secondary outcomes (3)
Executive Function
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.
Measured: change from baseline to 3 months
Global Cognition
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.
Measured: change from baseline to 3 months
Aerobic Fitness
change in 10 meter shuttle walk test
Measured: change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Oct 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moai Technologies LLC
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Dereck L Salisbury, PhD, Principal investigator, salis048@umn.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311736
- Sponsor's protocol ID
- EXERGAMES2
- Acronym
- Exergames
- Status last verified
- Mar 2020
- First submitted
- 17 Oct 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watry RA, Hadidi NN, Kreitzer MJ, Bhimani R, Yu F, Salisbury DL. Exercise Impact on Affective/Cognitive Symptoms and QoL in Subjective Cognitive Decline: An RCT. Am J Alzheimers Dis Other Demen. 2026 Jan-Dec;41:15333175261476974. doi: 10.1177/15333175261476974. Epub 2026 Aug 10.
PubMed 42574716Salisbury DL, Pituch KA, Yu F. The Effects of Exergame Telerehabilitation in Persons With Subjective Cognitive Decline. Gerontologist. 2024 Jun 1;64(6):gnae028. doi: 10.1093/geront/gnae028.
PubMed 38486359Salisbury 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.
PubMed 33407727
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergame Study)
- ClinicalTrials.gov ID
- NCT04311736
- Acronym / sponsor ID
- Exergames / EXERGAMES2
- Conditions
- Mild Cognitive Impairment, Exercise Training
- Keywords
- mild cognitive impairment, cognitive decline, aerobic exercise, physical exercise, exercise training, cognitive exercise, cognitive games, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Moai Technologies LLCUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exergame | Active comparator | Behavioral: ExergameModerate intensity cycling only 3 times per week for 12 weeks + concurrent virtual reality cognitive training, supervised by an exercise specialist |
| Cycling | Active comparator | Behavioral: CyclingModerate intensity cycling only 3 times per week for 12 weeks, supervised by an exercise specialist |
| Stretching | Sham comparator | Behavioral: StretchingStretching 3 times per week for 12 weeks, supervised by a therapist |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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?");
- 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;
- Written consent.
- Medical clearance to participate in a supervised exercise program
Key exclusion criteria (5 listed)
- Resting heart rate > 100 or <50 beats/min with symptoms;
- Dementia or mild cognitive impairment (self-report, diagnosis, or scoring <26 on the Telephone Interview for Cognitive Status;
- 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;
- Current enrollment in another intervention study;
- ACSM contraindications to exercise or other factors that make exercise impossible or unsafe.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergameCycling on a recumbent cycle ergometer + Virtual Reality Cognitive Training | Behavioural | Exergame |
| CyclingCycling on a recumbent cycle ergometer | Behavioural | Cycling |
| StretchingStretching exercises | Behavioural | Stretching |
Primary outcome
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.
3 secondary outcomes
Executive Function
Time frame: change from baseline to 3 months
Global Cognition
Time frame: change from baseline to 3 months
Aerobic Fitness
Time frame: change from baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 42574716Watry RA, Hadidi NN, Kreitzer MJ, Bhimani R, Yu F, Salisbury DL. Exercise Impact on Affective/Cognitive Symptoms and QoL in Subjective Cognitive Decline: An RCT. Am J Alzheimers Dis Other Demen. 2026 Jan-Dec;41:15333175261476974. doi: 10.1177/15333175261476974. Epub 2026 Aug 10.
- Derived from this study: PubMed 38486359Salisbury DL, Pituch KA, Yu F. The Effects of Exergame Telerehabilitation in Persons With Subjective Cognitive Decline. Gerontologist. 2024 Jun 1;64(6):gnae028. doi: 10.1093/geront/gnae028.
- Derived from this study: PubMed 33407727Salisbury 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dereck L Salisbury, PhD principal investigator
salis048@umn.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame, Cycling and Stretching in people with Mild Cognitive Impairment and Exercise Training, run by Moai Technologies LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Russell L Spafford, MS (612-626-6045, spaff010@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodic Memory (time frame: change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311736, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.