Medial Tibial Stress Syndrome Prevention

November 25, 2025 updated by: Rowan University

Efficacy of a Lower Leg Strengthening Program in the Prevention of MTSS in Collegiate XC Runners

This randomized controlled trial investigated whether a 10-week heavy resistance training program reduced the incidence of medial tibial stress syndrome (MTSS) in collegiate indoor track and field athletes. Twenty-six athletes from Rowan University were randomly assigned to a treatment group (resistance training plus regular training) or a control group (regular training only). Muscle mechanical properties-including tone, stiffness, elasticity, stress relaxation time, and creep-were measured by MyotonPro device (non-invasive) at baseline, post-intervention, and at the end of the season. A 10-week observational follow-up during the indoor season included weekly MTSS symptom surveys. Differences in MTSS incidence and muscle properties were analyzed between groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • New Jersey
      • Glassboro, New Jersey, United States, 08028
        • Rowan University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Collegiate athletes on the Indoor Track and Field team.
  • Athletes must participate in at least one of the following:
  • 60m-800m events (including hurdles)
  • jumping events (including pole vault)

Exclusion Criteria:

  • Subjects who have a history of musculoskeletal or neurologic conditions
  • Who take medications that affect muscle tone
  • Who have a body mass index >30.0 kg/m2 were excluded to screen to prevent adipose tissue from skewing the measurements.
  • Any subject with any fractures, sprains, or strains of the lower extremities were excluded.
  • Any subject with active MTSS, stress fracture, or other lower leg pathology symptoms at the time the initial survey was administered were excluded.
  • Any athlete who does not participate in the 60m-800m events (including hurdles), or who does not participate in jumping events (including pole vault) were excluded.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Resistance Training Intervention
Participants who received the heavy resistance training intervention in addition to their regular training.
Other: Resistance Training
Participants performed a 10-week resistance training program, completing exercises twice daily for Weeks 1-2 and three times daily for Weeks 3-10, with 5 sessions per week for Weeks 1-7 and 6 sessions per week for Weeks 8-10. The program included exercises such as standing broad jumps, resisted ankle abduction, single-leg eccentric plantar flexion, and ankle rockers. Participants' muscle properties were assessed at the start and end of the intervention, with adherence monitored via remote video confirmation.
No Intervention: Regular Training
Participants who continued their regular training without the additional intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Subjective Medial Tibial Stress Syndrome Symptoms
Time Frame: Through the running season -- approximately 11 weeks
Medial Tibial Stress Syndrome (MTSS) Score Survey
Through the running season -- approximately 11 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Myotonometry Oscillation frequency
Time Frame: From enrollment through the end of data collection -- approximately 25 weeks
Represents the intrinsic tension of the muscle in its passive state, essentially the muscle's "tone".
From enrollment through the end of data collection -- approximately 25 weeks
Myotonometry dynamic stiffness
Time Frame: From enrollment through the end of data collection -- approximately 25 weeks
Measures the resistance of the tissue to deformation when subjected to an external force.
From enrollment through the end of data collection -- approximately 25 weeks
Myotonometry logarithmic decrement
Time Frame: From enrollment through the end of data collection -- approximately 25 weeks
Indicates the elasticity of the muscle
From enrollment through the end of data collection -- approximately 25 weeks
Myotonometry mechanical stress relaxation time
Time Frame: From enrollment through the end of data collection -- approximately 25 weeks
Measures the time it takes for the muscle to return to its original shape after being deformed.
From enrollment through the end of data collection -- approximately 25 weeks
Myotonometry creep
Time Frame: From enrollment through the end of data collection -- approximately 25 weeks
Describes the gradual elongation of the muscle under constant tensile stress over time.
From enrollment through the end of data collection -- approximately 25 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rowan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer A Longo, PhD, Rowan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro-2023-75

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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