Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (Exergames)
Primary Purpose
Mild Cognitive Impairment, Exercise Training
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exergame
Cycling
Stretching
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, cognitive decline, aerobic exercise, physical exercise, exercise training, cognitive exercise, cognitive games, virtual reality
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Exergame
Cycling
Stretching
Arm Description
Moderate intensity cycling only 3 times per week for 12 weeks + concurrent virtual reality cognitive training, supervised by an exercise specialist
Moderate intensity cycling only 3 times per week for 12 weeks, supervised by an exercise specialist
Stretching 3 times per week for 12 weeks, supervised by a therapist
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Aerobic Fitness
change in 10 meter shuttle walk test
Full Information
NCT ID
NCT04311736
First Posted
October 17, 2019
Last Updated
March 16, 2020
Sponsor
Moai Technologies LLC
Collaborators
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04311736
Brief Title
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults
Acronym
Exergames
Official Title
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergame Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moai Technologies LLC
Collaborators
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Exercise Training
Keywords
mild cognitive impairment, cognitive decline, aerobic exercise, physical exercise, exercise training, cognitive exercise, cognitive games, virtual reality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exergame
Arm Type
Active Comparator
Arm Description
Moderate intensity cycling only 3 times per week for 12 weeks + concurrent virtual reality cognitive training, supervised by an exercise specialist
Arm Title
Cycling
Arm Type
Active Comparator
Arm Description
Moderate intensity cycling only 3 times per week for 12 weeks, supervised by an exercise specialist
Arm Title
Stretching
Arm Type
Sham Comparator
Arm Description
Stretching 3 times per week for 12 weeks, supervised by a therapist
Intervention Type
Behavioral
Intervention Name(s)
Exergame
Intervention Description
Cycling on a recumbent cycle ergometer + Virtual Reality Cognitive Training
Intervention Type
Behavioral
Intervention Name(s)
Cycling
Intervention Description
Cycling on a recumbent cycle ergometer
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Intervention Description
Stretching exercises
Primary Outcome Measure Information:
Title
Episodic Memory
Description
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.
Time Frame
change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Executive Function
Description
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.
Time Frame
change from baseline to 3 months
Title
Global Cognition
Description
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.
Time Frame
change from baseline to 3 months
Title
Aerobic Fitness
Description
change in 10 meter shuttle walk test
Time Frame
change from baseline to 3 months
Other Pre-specified Outcome Measures:
Title
Physical Function
Description
change in 6 minute walk test
Time Frame
change from baseline to 3 months
Title
Physical Function
Description
change in Short Physical Performance Battery Score-Balance
Time Frame
change from baseline to 3 month
Title
Physical Function
Description
change in short physical performance battery score-Sit to stand
Time Frame
change from baseline to 3 months
Title
Physical Function
Description
change in short physical performance battery score-4 meter Gait speed
Time Frame
change from baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Russell L Spafford, MS
Phone
612-626-6045
Email
spaff010@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sue Greimel, MS
Phone
612-626-9490
Email
moone104@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dereck L Salisbury, PhD
Organizational Affiliation
salis048@umn.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell L Spafford, MS
Phone
612-626-6045
Email
spaff010@umn.edu
First Name & Middle Initial & Last Name & Degree
Dereck L Salisbury, PhD
Phone
612-625-9308
Email
salis048@umn.edu
First Name & Middle Initial & Last Name & Degree
Dereck L Salisbury, PhD
First Name & Middle Initial & Last Name & Degree
Tom Plocher, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33407727
Citation
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.
Results Reference
derived
Learn more about this trial
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults
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