Back to resultsAcute Effect of Motor-Cognitive Training
Primary Purpose
Injury;Sports
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motor-Cognitive Training Program
Sponsored by
About this trial
This is an interventional prevention trial for Injury;Sports focused on measuring injury prevention, cognition, physical performance, athletic training
Eligibility Criteria
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
Sites / Locations
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physically active females
Arm Description
Healthy active females between 18 and 25
Outcomes
Primary Outcome Measures
Change in brain activation
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.
Change in functional connectivity
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.
Change in reaction time
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.
Change in accuracy
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.
Secondary Outcome Measures
Demographic/Injury History Form
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.
Defense Veterans Pain Rating Scale
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.
Modified Disablement In Physically Active Scale
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.
NASA Physical Activity Survey
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.
Heart rate
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.
Average reaction time during the intervention
Average reaction time in milliseconds will be captured during the exercises via light sensors.
Misses 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.
Hits 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.
Number of errors 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.
Rate of perceived exertion
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
Perceived cognitive difficulty
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06017154
Brief Title
Acute Effect of Motor-Cognitive Training
Official Title
The Acute Effects of Brain Activation and Functional Connectivity Following Motor-cognitive Training Using Functional MRI
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ke'La H Porter
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury;Sports
Keywords
injury prevention, cognition, physical performance, athletic training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physically active females
Arm Type
Experimental
Arm Description
Healthy active females between 18 and 25
Intervention Type
Other
Intervention Name(s)
Motor-Cognitive Training Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in brain activation
Description
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.
Time Frame
2 hours, pre-training session and immediately post-training session
Title
Change in functional connectivity
Description
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.
Time Frame
2 hours, pre-training session and immediately post-training session
Title
Change in reaction time
Description
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.
Time Frame
2 hours, pre-training session and immediately post-training session
Title
Change in accuracy
Description
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.
Time Frame
2 hours, pre-training session and immediately post-training session
Secondary Outcome Measure Information:
Title
Demographic/Injury History Form
Description
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.
Time Frame
Once, pre-training
Title
Defense Veterans Pain Rating Scale
Description
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.
Time Frame
Once, pre-training
Title
Modified Disablement In Physically Active Scale
Description
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.
Time Frame
Once, pre-training
Title
NASA Physical Activity Survey
Description
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.
Time Frame
Once, pre-training
Title
Heart rate
Description
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.
Time Frame
35 minutes, during the training session
Title
Average reaction time during the intervention
Description
Average reaction time in milliseconds will be captured during the exercises via light sensors.
Time Frame
30 minutes, during the training session
Title
Misses during the training session
Description
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.
Time Frame
30 minutes, during the training session
Title
Hits during the training session
Description
The number of hits will be captured during the exercises via light sensors. A hit is considered when they deactivate the correct sensor.
Time Frame
30 minutes, during the training session
Title
Number of errors during the training session
Description
The number of errors will be captured during the exercises by visual observation. An error occurs when they do not complete they exercise correctly.
Time Frame
30 minutes, during the training session
Title
Rate of perceived exertion
Description
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
Time Frame
30 minutes, during the training session
Title
Perceived cognitive difficulty
Description
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
Time Frame
30 minutes, during the training session
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ke'La H Porter, MS
Phone
859-323-9850
Email
kela.porter@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew C Hoch, PhD
Email
matt.hoch@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke'La H Porter, MS
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke'La Porter, MS
Phone
859-323-9850
Email
kela.porter@uky.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Acute Effect of Motor-Cognitive Training
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