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

NCT04311736 | Unknown

• 1 other identifier: EXERGAMES2
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  change from baseline to 3 months

Secondary Outcomes (3)

• Executive Function

  change from baseline to 3 months

• Global Cognition

  change from baseline to 3 months

• Aerobic Fitness

  change from baseline to 3 months

Other Outcomes (4)

• Physical Function

  change from baseline to 3 months

• Physical Function

  change from baseline to 3 month

• Physical Function

  change from baseline to 3 months

Study Arms (3)

Exergame

ACTIVE COMPARATOR

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

Behavioral: Exergame

Cycling

ACTIVE COMPARATOR

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

Behavioral: Cycling

Stretching

SHAM COMPARATOR

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

Behavioral: Stretching

Interventions

Exergame BEHAVIORAL

Cycling on a recumbent cycle ergometer + Virtual Reality Cognitive Training

Exergame

Cycling BEHAVIORAL

Cycling on a recumbent cycle ergometer

Cycling

Stretching BEHAVIORAL

Stretching exercises

Stretching

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moai Technologies LLC: lead
• University of Minnesota: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (2)

• Salisbury 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.

  PMID: 38486359 DERIVED

• 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.

  PMID: 33407727 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dereck L Salisbury, PhD

  salis048@umn.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Russell L Spafford, MS

CONTACT

612-626-6045; spaff010@umn.edu

Sue Greimel, MS

CONTACT

612-626-9490; moone104@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: March 17, 2020
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)