NCT06748417

Brief Summary

The purpose of this study is to assess the reliability of outcomes collected using a speed and cognitive light training system. This study will also be used to understand the effects of brain training on athletic performance using the FITLIGHT System.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 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

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 18, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

December 19, 2024

Last Update Submit

September 6, 2025

Conditions

Athletic Injuries

Keywords

Reaction timeneurocognitive performanceAgility training

Outcome Measures

Primary Outcomes (4)

  • Change in Reaction Time

    Will be measured in seconds (s)

    Up to 5 minutes before and up to 5 minutes after intervention

  • Change in Percentage of Correct Responses in Cognitive-Motor Running T-test

    Percentage of correct responses on cognitive-motor test

    Up to 5 minutes before and up to 5 minutes after intervention

  • Change in Completion Time

    Will be measured in seconds (s)

    Up to 5 minutes before and up to 5 minutes after intervention

  • Change in Hop distance

    Will be measured in meters (m)

    Up to 10 minutes before and up to 10 minutes after intervention

Study Arms (2)

Acute Cognitive Training Followed by Non-stimulating Rest Group

EXPERIMENTAL

Participants will be in this group for approximately 11-14 days

Device: Acute Cognitive TrainingOther: Non-stimulating Rest

Non-stimulating rest followed by acute cognitive training Group

EXPERIMENTAL

Participants will be in this group for approximately 11-14 days

Device: Acute Cognitive TrainingOther: Non-stimulating Rest

Interventions

Acute Cognitive TrainingDEVICE

Participants will receive the intervention in person once within in the study for 30 minutes. During the intervention, participants will receive a cognitive training session consisting of an upper extremity, lower extremity, and whole-body reaction time task. The device (5 LED) will be placed in front of participants in all tasks, and participants will be asked to deactivate lights that illuminate for a period of 30 seconds with 30 seconds of rest. For the upper and lower extremity tasks, these will be repeated on both limbs. The purpose of the tasks are to pre-train reaction time in an isolated fashion, requiring participants to use either hands or feet to deactivate the lights, as well as incorporate whole-body movement in the third task along with a decision-making (color-matching) component.

Also known as: FITLIGHT
Acute Cognitive Training Followed by Non-stimulating Rest GroupNon-stimulating rest followed by acute cognitive training Group
Non-stimulating RestOTHER

Participants will receive the intervention in person once within the study for 30 minutes. During the intervention, participants will watch, while seated, a 30-minute segment of a nature documentary. The purpose of this intervention is to ensure no additional cognitive or movement training that would improve performance on the dual-task test occurs during the intended rest period.

Acute Cognitive Training Followed by Non-stimulating Rest GroupNon-stimulating rest followed by acute cognitive training Group

Eligibility Criteria

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

You may qualify if:

  • Healthy as determined by a Physical Activity Readiness Questionnaire
  • BMI under 30

You may not qualify if:

  • Color-blindness
  • Fractures within the past year
  • Musculoskeletal injury limiting sports activity within the past 6 months
  • Anterior cruciate ligament (ACL) injuries within the past 5 years
  • Medical conditions that do not have physician clearance to participate in exercise
  • History of concussion
  • Diagnosed cognitive impairments
  • Untreated attention deficit/hyperactivity disorder (ADHD) or attention deficit disorder (ADD)
  • Prisoners
  • Pregnant women
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Zachary A Ripic, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

February 18, 2025

Primary Completion

September 5, 2025

Study Completion

September 5, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)