NCT06017154

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

August 18, 2023

Last Update Submit

April 11, 2024

Conditions

Keywords

injury preventioncognitionphysical performanceathletic training

Outcome Measures

Primary Outcomes (4)

  • 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.

    2 hours, pre-training session and immediately post-training session

  • 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.

    2 hours, pre-training session and immediately post-training session

  • 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.

    2 hours, pre-training session and immediately post-training session

  • 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.

    2 hours, pre-training session and immediately post-training session

Secondary Outcomes (11)

  • Demographic/Injury History Form

    Once, pre-training

  • Defense Veterans Pain Rating Scale

    Once, pre-training

  • Modified Disablement In Physically Active Scale

    Once, pre-training

  • NASA Physical Activity Survey

    Once, pre-training

  • Heart rate

    35 minutes, during the training session

  • +6 more secondary outcomes

Study Arms (1)

Physically active females

EXPERIMENTAL

Healthy active females between 18 and 25

Other: Motor-Cognitive Training Program

Interventions

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

Physically active females

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Ke'La H Porter, MS

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Analyst Principal

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 30, 2023

Study Start

September 17, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

April 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations