NCT04095260

Brief Summary

The purpose of this study is to complete a neuromuscular performance assessment of high school athletes who are participating in school based pre-season strength and performance training program. The performance assessment will screen for existing muscle imbalances and strength deficits known to increase risk for sports injury, and provide a baseline performance measurement. Athletes will be measured before the start of the program and then again at the end of the pre-season training period to measure changes in motor coordination, muscle strength, and performance and injury risk category. Internal and external training load will be measured weekly during the training program to track intensity of the training program. In addition to the pre and post measurements, sports injury occurrence and time away from sports participation will be tracked throughout the sport season/school year to evaluate training program outcomes and accuracy of risk assessment.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Aug 2028

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

September 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
8.9 years until next milestone

Study Start

First participant enrolled

August 1, 2028

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2029

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

September 16, 2019

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in baseline movement quality as measured by the Selective Functional Movement Assessment (SFMA).

    The Selective Functional Movement Assessment is an assessment to score movement quality on 7 functional movements. The movement is categorically scored as: Functional and not painful (FN); Functional and painful (FP); Dysfunctional and not painful (DN); Dysfunctional and painful (DP)

    Pre (initial baseline), and after week 8 of preseason strength and condition training program

  • Change in muscle strength testing as measured by hand held dynamometer.

    Hand held dynamometer measures isometric force production in kilograms or pounds.

    Pre (initial baseline) and after week 8 of preseason strength and condition training program

  • Change in baseline movement quality as measured by the Anterior reach of the Y Balance Test.

    The Anterior reach of the Y Balance Test measures distance of limb reach in centimeters. Distance is compared from one side to the other to assess for symmetry. A difference of \> 4cm is a positive risk factor for lower extremity injury.

    Pre (initial baseline) and after week 8 of preseason strength and condition training program

  • Change in baseline in motor performance as measured by the Single Leg Hop jump distance.

    Single leg hop test measures hop distance in centimeters. Distance hopped is compared between limbs, comparing strength and power symmetry between the two limbs.

    Pre (initial baseline) and after week 8 of preseason strength and condition training program

  • Change in baseline in motor performance as measured by the Modified T-Test drill completion time (seconds).

    The Modified T-Test is an agility test that incorporates quick direction changes in a defined pattern. The test is measured in seconds. A reduction in the time to complete the drill represents improved motor performance and power.

    Pre (initial baseline) and after week 8 of preseason strength and condition training program

Secondary Outcomes (2)

  • Number of participants who experience a musculoskeletal sports related injury.

    End of study (1 year)

  • Intrinsic training load as measured by perceived effort of the training session (Rate of Perceived Exertion Scale)

    Weekly, for 8 weeks during the strength and conditioning training program

Study Arms (1)

high school athletes

High school athletes, ages 14 to 18, who are participating in an organized sports training program.

Other: Pre-season strength and conditioning program

Interventions

The structured physical performance assessment will include functional movement testing, motor coordination testing, joint mobility screen, muscle strength testing, and agility performance testing. These measures will assess the effectiveness of pre-season strength and conditioning program to reduce musculoskeletal impairments and increase resistance to injury.

Also known as: pre and post physical performance testing following a high school based strength and conditioning training program
high school athletes

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

High school athletes, ages 14 to 18, who are participating in an organized sports training program. The target subject enrollment is 250 high school athletes.

You may qualify if:

  • athletes who have completed a pre-participation sports physical
  • are enrolled in a sports elective or a member of a sports team
  • have volunteered to participate in the study providing both verbal and written consent.

You may not qualify if:

  • athletes who have not submitted a pre-participation sports physical to the high school training staff
  • student athletes who are currently suffering from an acute neuromusculoskeletal injury with restrictions on athletic participation
  • an athlete who has undergone surgery within a 3 month period of the program start date
  • an athlete who presents with a cardiovascular condition that would exclude exercise participation (systolic BP \> 180, diastolic BP \> 100)
  • an athletes who are currently pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clear Falls High School

League City, Texas, 77573, United States

Location

MeSH Terms

Conditions

Athletic Injuries

Interventions

Lead

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Janna M McGaugh, ScD

    UTMB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janna M McGaugh, ScD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 19, 2019

Study Start (Estimated)

August 1, 2028

Primary Completion (Estimated)

August 30, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations