Effects of Muscle Fatigue

May 29, 2025 updated by: Yasemin Şahbaz, University of Beykent

Investigation of the Effects of Muscle Fatigue in Healthy Young Adults

This study aims to investigate the acute effects of fatigue in the tibialis anterior and gastrocnemius muscles on joint position sense, balance, pain threshold, and muscle elasticity in healthy young adults. Muscle fatigue is known to directly affect physical performance and motor function; therefore, understanding its influence on neuromuscular parameters such as proprioception, postural control, and tissue properties is of great importance. By examining how these specific muscle groups respond to fatigue, the study seeks to clarify the role of fatigue in altering joint position sense, balance performance, pain perception, and muscle mechanical properties. The findings of this research are expected to provide new insights that may contribute to the development of more effective strategies in physical therapy and rehabilitation practices.

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.

Detailed Description

Study Aim and Rationale This study aims to investigate the acute effects of fatigue in the tibialis anterior and gastrocnemius muscles on joint position sense, dynamic balance, muscle elasticity, and pain threshold in healthy young adults. Muscle fatigue is known to directly impact motor function and physical performance; therefore, understanding its influence on neuromuscular parameters such as proprioception, postural control, and biomechanical properties is crucial for developing effective clinical strategies. By evaluating how these specific muscle groups respond to fatigue, the study seeks to generate evidence that can guide physiotherapy and rehabilitation practices.

Methodology A total of 35 healthy adults aged 18-24 who meet the inclusion criteria will participate. All procedures will be conducted at the Physiotherapy and Rehabilitation Laboratory of Istanbul Beykent University. Dominant lower limbs, determined by the foot used in a spontaneous ball-kicking task, will be used for testing. Participants will first undergo a tibialis anterior fatigue protocol, followed one week later by a gastrocnemius fatigue protocol. Each participant will be assessed at four time points: before the fatigue protocol, immediately after, 24 hours later, and 48 hours later.

Participants will be instructed to refrain from high-intensity exercise, stretching, massage, hot/cold applications, and medications for 48 hours prior to testing. These instructions will be provided both verbally and in writing.

Fatigue will be induced through repeated isometric contractions (30 seconds contraction, 15 seconds rest). For tibialis anterior, participants will lie supine and perform dorsiflexion against resistance at a fixed 100° ankle angle using a customized apparatus. For gastrocnemius, participants will lie prone with feet hanging off the table and perform plantarflexion against a wall. Fatigue threshold will be defined as a score ≥7 on the Modified Borg Scale.

Assessments will include:

Joint Position Sense (JPS): Measured using active angle reproduction at 10° dorsiflexion and 20° plantarflexion. The DrGoniometer app will record angular error, and absolute error values will be computed.

Dynamic Balance: Assessed with the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions. Reach distances will be normalized to limb length, and composite scores will be calculated.

Muscle Elasticity: Evaluated using the MyotonPro device in multiscan mode with standardized settings. Measurements will be taken from the most prominent points of the tibialis anterior, medial gastrocnemius, and lateral gastrocnemius.

Pain Threshold: Measured using a pressure algometer device.

Fatigue Metrics: Captured with the ForceDecks dual force plate system (VALD Performance). The system will record jump height, concentric peak velocity, eccentric duration, braking phase duration, peak power, and RSI-mod index.

All assessments are non-invasive and conducted under standardized conditions. Rest periods will be provided between tests to prevent cumulative fatigue from affecting results.

Sample Size and Randomization Sample size was calculated using G*Power (α=0.05, power=95%) based on stiffness values of the medial gastrocnemius reported by Lall (2022). The required sample size was 29; to compensate for potential dropouts, 35 participants will be included. Simple randomization will be conducted from a list of 200 eligible individuals using randomizer.org.

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.
35

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

  • Turkey
    • Büyükçekmece
      • İ̇stanbul, Büyükçekmece, Turkey
        • Istanbul Beykent University Physiotherapy Lab.

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged between 18 and 24 years
  • Body Mass Index (BMI) between 18.5 and 24.9
  • Low to moderate physical activity level
  • No history of neurological or orthopedic disorders
  • Full range of motion in the ankle joint
  • Voluntary participation and informed consent provided

Exclusion Criteria:

  • Does not meet the inclusion criteria
  • History of trauma or surgery in the lower extremities
  • Regular participation in exercise or being a professional athlete

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover 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: Tibialis Anterior Fatigue Protocol
Participants perform isometric dorsiflexion exercises targeting the tibialis anterior muscle in a supine position using a custom-designed apparatus fixed at 100° ankle dorsiflexion. The fatigue protocol includes 30-second contraction and 15-second rest cycles, repeated until a score of ≥7 is reached on the Modified Borg Scale. Neuromuscular assessments-including joint position sense, dynamic balance, muscle elasticity, pain threshold, and fatigue metrics-are conducted at four time points: before, immediately after, 24 hours, and 48 hours post-protocol.
Behavioral: Tibialis Anterior Fatigue Protocol
Participants lie in a supine position with the ankle fixed at 100° dorsiflexion using a custom apparatus. They perform repeated isometric dorsiflexion contractions for 30 seconds followed by 15 seconds of rest. The protocol continues until a perceived exertion of ≥7 is reported on the Modified Borg Scale. Evaluations include joint position sense, balance, muscle elasticity, pain threshold, and performance metrics recorded at four time points: pre-, post-, 24h, and 48h.
Experimental: Gastrocnemius Fatigue Protocol
Participants perform isometric plantarflexion exercises targeting the gastrocnemius muscle while in a prone position with the foot pressing against a wall. The protocol consists of repeated 30-second contractions and 15-second rest cycles until a Modified Borg Scale score of ≥7 is reported. Evaluations of joint position sense, balance, muscle elasticity, pain threshold, and performance-based fatigue metrics are conducted at the same time intervals: before, immediately after, 24 hours, and 48 hours following the protocol.
Behavioral: Gastrocnemius Fatigue Protocol
Participants lie in a prone position with their foot placed against a wall. They perform repeated isometric plantarflexion contractions for 30 seconds with 15 seconds of rest between repetitions. The exercise is continued until a Modified Borg score of ≥7 is reached. Measurements of neuromuscular and biomechanical parameters are conducted at the same four time points: before, immediately after, 24 hours, and 48 hours post-exercise.

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
Change in Joint Position Sense (JPS)
Time Frame: Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue

Absolute error (in degrees) in ankle joint position sense measured using the active angle reproduction method with the DrGoniometer app.

bsolute error (in degrees) in ankle joint position sense measured using the active angle reproduction method with the DrGoniometer app.

bsolute error (in degrees) in ankle joint position sense measured using the active angle reproduction method with the DrGoniometer app.
Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue
Change in Dynamic Balance Performance
Time Frame: Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue
Normalized reach distance and composite score from the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions.
Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue
Change in Muscle Elasticity
Time Frame: Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue
Normalized reach distance and composite score from the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions.
Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue

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
Force Plate Fatigue Metrics
Time Frame: Baseline and immediately post-fatigue
Performance and time-based measures collected via ForceDecks dual force plates, including jump height, peak power, RSI-mod, and contraction durations.
Baseline and immediately post-fatigue

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.
University of Beykent

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.
February 1, 2025

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.
April 15, 2025

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.
May 20, 2025

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 29, 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.
May 29, 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.
June 6, 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.
June 6, 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.
May 29, 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

Keywords

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.
  • UBeykent-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study does not plan to share individual participant data (IPD) due to ethical considerations and institutional policies regarding participant confidentiality.

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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