NCT05296551

Brief Summary

This study seeks to understand what factors influence the capacity to perform simultaneous motor and cognitive tasks in older adults to improve movement throughout their community with the least risk of injury. To function in the real world, one needs to "walk and talk", or to move about the community while attending to their environment. Navigating a busy environment becomes increasingly difficult due to the multitude of constraints placed on the organism by both the brain and the body that are associated with aging. Resulting lack of movement causes a downward spiral; further decreasing function and increasing risk of co-morbidities. This will impose an enormous cost on our healthcare system as the elderly population continues to grow in the United States. The investigators aim to investigate both cognitive and movement changes during aging to prevent declines in functional mobility. The investigators will do this through eight weeks training of simultaneous cognitive and motor tasks (cognitive-motor training).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

March 5, 2022

Last Update Submit

May 9, 2024

Conditions

Keywords

Dual-TaskCognitive-Motor InterferenceFunctional MobilityCognitionMotor Performance

Outcome Measures

Primary Outcomes (3)

  • Change in Timed Up and Go Tests in 4 week increments

    Timed Up and Go, and Timed Up and Go Cognitive

    Baseline, Week 4, and Week 8

  • Change in 10 meter walk test self-selected pace in 4 week increments

    self selected pace walking over an instrumented mat (ZenoMat) both single task and while counting serial 3's

    Baseline, Week 4, and Week 8

  • Change in Cognition in 4 week increments

    Components of Cognitive Fluidity as measured by the NIH Toolbox Cognitive Battery

    Baseline, Week 4, and Week 8

Secondary Outcomes (3)

  • Balance Test Performance in 4 week increments

    Baseline, Week 4, and Week 8

  • change in 10 meter walk test fast pace in 4 week increments

    Baseline, Week 4, and Week 8

  • Change in Muscle Electromyography in 4 week increments

    Baseline, Week 4 and Week 8

Study Arms (3)

Dual Task One

EXPERIMENTAL

Participants perform a cognitive-motor dual-task where the motor task is the same for all groups and the simultaneously performed cognitive task is simple.

Other: Cognitive-motor dual-task

Dual Task Two

EXPERIMENTAL

Participants perform a cognitive-motor dual-task where the motor task is the same for all groups and the simultaneously performed cognitive task is complex.

Other: Cognitive-motor dual-task

Control

ACTIVE COMPARATOR

Participants perform only a motor-task that is the same for all groups (no simultaneous cognitive task).

Other: Motor Task

Interventions

A visuomotor task is presented where an individual must match their knee to an ellipse that moves up and down on a screen, resulting in a marching-in-place motion at a specified frequency.

Control

While performing the "Motor Task" intervention, letters of different colors and orientation randomly appear one at a time on the screen. During the Cognitive-motor dual-task, individuals are instructed to count the number of times that either 1 (simple cognitive task), or 2 (complex cognitive task) characters appear on the screen during the motor task.

Dual Task OneDual Task Two

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 60 and 95 Years Old
  • Self-described as generally healthy
  • Normal or corrected to normal vision
  • Able to stand on one foot for at least 3 seconds with minimal sway and no loss of balance

You may not qualify if:

  • Known neurologic disorder affecting mobility or cognition
  • Self-reported known moderate or greater lower extremity arthritis
  • Known disease process that affects muscle function
  • Color Blindness
  • Lower extremity pain in the previous 15 days
  • Known learning or attention deficit
  • Currently taking medication that affects attention, learning, and/or memory
  • Known Cardiovascular Disease of previous heart attack or cardiomyopathy
  • Chronic Kidney Disease
  • Severe Obesity as defined by a BMI of greater than or equal to 40 Kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Washington University, Department of Health, Human Function and Rehabilitation Science

Washington D.C., District of Columbia, 20006, United States

Location

Related Publications (54)

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Study Officials

  • Keith Cole, DPT, Ph. D.

    The George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects are block randomized into 3 parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 5, 2022

First Posted

March 25, 2022

Study Start

March 3, 2022

Primary Completion

May 5, 2024

Study Completion

May 5, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations