- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06017154
Acute Effect of Motor-Cognitive Training
April 11, 2024 updated by: Ke'La H Porter
The Acute Effects of Brain Activation and Functional Connectivity Following Motor-cognitive Training Using Functional MRI
Participants will complete a functional MRI to evaluate brain activation, functional connectivity, and behavioral performance immediately before and after a training program (approximately 30 minutes).
The training program will comprise of integrate neuromuscular (agility, dynamic postural stability, shuffling, rapid acceleration/deceleration, plyometrics, lateral shuffle, and core stability) and cognitive (reaction time, processing speed, task switching, decision-making, and working memory) challenges.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ke'La H Porter, MS
- Phone Number: 859-323-9850
- Email: kela.porter@uky.edu
Study Contact Backup
- Name: Matthew C Hoch, PhD
- Email: matt.hoch@uky.edu
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- University of Kentucky
-
Contact:
- Ke'La Porter, MS
- Phone Number: 859-323-9850
- Email: kela.porter@uky.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Physically active
Exclusion Criteria:
- Injury to the muscle or bone (upper extremity, lower extremity, or back) within the past 3 months
- Had musculoskeletal surgery or fracture (required open reduction internal fixation or within the last 12 months)
- Had a concussion or mild head injury within the last year
- Have been diagnosed with any kind of neurological, vestibular, or visual disturbance that impairs mobility
- Currently taking medications that affect the central nervous system
- Pregnant or suspicions of being pregnant
- Have metal fragments, pins, plates, or clips, shrapnel, body piercings that cannot be removed, have surgical implants or orthodontics that cannot be removed
- Have claustrophobia
- Have a history of cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physically active females
Healthy active females between 18 and 25
|
The training will incorporate cognitive tasks which focus on reaction time, processing speed, working memory, cognitive flexibility, and inhibitory control using visual stimuli on a screen or through sensors which illuminate using LED lights.
These cognitive tasks will be performed while also executing physical performance tasks that challenge static and dynamic postural stability, lateral movement, agility, and other movement patterns.
The training session will last approximately 30 minutes and participants will complete up to 5 exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in brain activation
Time Frame: 2 hours, pre-training session and immediately post-training session
|
During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue).
They will respond using a trigger under their left and right foot.
The level of brain activation during the task will be captured and reported.
|
2 hours, pre-training session and immediately post-training session
|
Change in functional connectivity
Time Frame: 2 hours, pre-training session and immediately post-training session
|
The participant will complete a resting-state functional MRI scan in which they will lay still in the scanner.
No task is performed during this scan.
Functional connectivity (functionally related regions of the brain that are co-activated) during the scan will be captured and reported.
|
2 hours, pre-training session and immediately post-training session
|
Change in reaction time
Time Frame: 2 hours, pre-training session and immediately post-training session
|
During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue).
They will respond using a trigger under their left and right foot.
The reaction time in milliseconds will be captured.
The change in reaction time from pre to post training session will be reported.
|
2 hours, pre-training session and immediately post-training session
|
Change in accuracy
Time Frame: 2 hours, pre-training session and immediately post-training session
|
During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue).
They will respond using a trigger under their left and right foot.
The percent of correct responses (accuracy) will be captured.
The change in accuracy from pre to post training session will be reported.
|
2 hours, pre-training session and immediately post-training session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic/Injury History Form
Time Frame: Once, pre-training
|
The demographic and injury history form is designed to capture: 1) information about the participant including age, height, weight, race, ethnicity, 2) information related to sports participation, and 3) information related to past injuries or medical conditions which are relevant to the study.
|
Once, pre-training
|
Defense Veterans Pain Rating Scale
Time Frame: Once, pre-training
|
The Defense Veterans Pain Rating Scale is a valid 5-item scale to assess pain magnitude and pain interference.
This scale ranges from 0 to 10, 0 indicating no pain/interference and 10 indicating as bas as it could be/complete interference.
|
Once, pre-training
|
Modified Disablement In Physically Active Scale
Time Frame: Once, pre-training
|
16-item patient-reported outcome instrument that assesses physical and psychosocial status.This scale ranges from 0 to 4, 0 indicating no problem and 4 indicating severe.
|
Once, pre-training
|
NASA Physical Activity Survey
Time Frame: Once, pre-training
|
This survey asks individuals to self-report their general physical activity over the past week.
This survey ranges from 0 to 10, 0 indicating sedentary and 10 indicating high physical activity.
|
Once, pre-training
|
Heart rate
Time Frame: 35 minutes, during the training session
|
Heart rate will be monitored with a noninvasive heart rate monitor that will be worn by the participant around the chest at the level of the xiphoid process.
Resting heart rate will be collected prior to the start intervention then monitored and recorded throughout the training session.
|
35 minutes, during the training session
|
Average reaction time during the intervention
Time Frame: 30 minutes, during the training session
|
Average reaction time in milliseconds will be captured during the exercises via light sensors.
|
30 minutes, during the training session
|
Misses during the training session
Time Frame: 30 minutes, during the training session
|
The number of misses will be captured during the exercises via light sensors.
A miss is considered when they deactivate the wrong sensor or don't deactivate the sensor quickly enough.
|
30 minutes, during the training session
|
Hits during the training session
Time Frame: 30 minutes, during the training session
|
The number of hits will be captured during the exercises via light sensors.
A hit is considered when they deactivate the correct sensor.
|
30 minutes, during the training session
|
Number of errors during the training session
Time Frame: 30 minutes, during the training session
|
The number of errors will be captured during the exercises by visual observation.
An error occurs when they do not complete they exercise correctly.
|
30 minutes, during the training session
|
Rate of perceived exertion
Time Frame: 30 minutes, during the training session
|
After each exercise the participant will be asked to rate their perceived exertion on a scale from 6 to 20, 6 indicating low perceived exertion and 20 indicating high perceived exertion
|
30 minutes, during the training session
|
Perceived cognitive difficulty
Time Frame: 30 minutes, during the training session
|
After each exercise the participant will be asked to rate their perceived cognitive difficulty on a scale from 1 to 10, 1 indicating low cognitive challenge and 10 indicating high cognitive challenge
|
30 minutes, during the training session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ke'La H Porter, MS, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2023
Primary Completion (Actual)
February 5, 2024
Study Completion (Actual)
February 5, 2024
Study Registration Dates
First Submitted
August 18, 2023
First Submitted That Met QC Criteria
August 23, 2023
First Posted (Actual)
August 30, 2023
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 11, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 88851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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