NCT07324395

Brief Summary

The goal of this clinical trial is to learn how delayed onset muscle soreness (DOMS) in the calf muscle (gastrocnemius) affects the muscles of the posterior chain and physical performance in healthy young adults. The main questions the study aims to answer are: Does DOMS in the calf muscle change the biomechanical properties (tone, stiffness, elasticity) of other muscles in the posterior chain? Does DOMS lower trunk endurance, muscle strength, balance, or jump performance? Participants will: Take part in a gastrocnemius exercise protocol designed to safely create DOMS Complete repeated assessments at baseline, immediately after exercise, and at 24, 48, and 72 hours Have their muscle properties measured with a handheld device Complete trunk endurance tests, muscle strength tests, balance tests, and a vertical jump test Provide a blood sample to measure creatine kinase (a marker of muscle damage) This research may help clinicians better understand how soreness in one muscle can influence the whole posterior chain and may guide safer training and recovery strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

December 10, 2025

Last Update Submit

December 24, 2025

Conditions

Keywords

Delayed onset muscle sorenessposterior chain musclesTrunk Endurancemuscle stiffness

Outcome Measures

Primary Outcomes (8)

  • Muscle Biomechanical Properties (Muscle Tone)

    Muscle tone (F) will be assessed using the MyotonPRO device. Measurements will be recorded in Hertz (Hz). Measurements will be taken three times for each muscle segment, and the average value will be calculated. Standardized anatomical landmarks were used for each muscle: Gastrocnemius: measured at the thickest part of the medial head, approximately 10 cm below the popliteal crease. The location was confirmed with a tape measure to account for individual differences. Hamstrings: measured with the participant in a prone position, at the midpoint between the ischial tuberosity and the fibular head. Gluteus maximus: measured at the thickest portion of the muscle identified by palpation while the participant was prone. Erector spinae: measured 2.5 cm lateral to the L5 spinous process in the prone position. Measurement points were marked on the skin to en

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Muscle Biomechanical Properties (Muscle Stiffness)

    Muscle stiffness (S) will be assessed using the MyotonPRO device. Results will be reported in Newtons per meter (N/m). Measurements will be taken three times for each muscle segment, and the average value will be calculated. Standardized anatomical landmarks were used for each muscle: Gastrocnemius: measured at the thickest part of the medial head, approximately 10 cm below the popliteal crease. The location was confirmed with a tape measure to account for individual differences. Hamstrings: measured with the participant in a prone position, at the midpoint between the ischial tuberosity and the fibular head. Gluteus maximus: measured at the thickest portion of the muscle identified by palpation while the participant was prone. Erector spinae: measured 2.5 cm lateral to the L5 spinous process in the prone position. Measurement points were marked on the skin to en

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Muscle Biomechanical Properties (Muscle Elasticity)

    Muscle elasticity will be characterized by the logarithmic decrement (D) measured using the MyotonPRO device. This is a unitless (relative) value representing the ability of the muscle to restore its shape after deformation. Measurements will be taken three times for each muscle segment, and the average value will be calculated. Standardized anatomical landmarks were used for each muscle: Gastrocnemius: measured at the thickest part of the medial head, approximately 10 cm below the popliteal crease. The location was confirmed with a tape measure to account for individual differences. Hamstrings: measured with the participant in a prone position, at the midpoint between the ischial tuberosity and the fibular head. Gluteus maximus: measured at the thickest portion of the muscle identified by palpation while the participant was prone. Erector spinae: measured 2.5 cm lateral to the L5 spinous process in the prone position. Measurement points were marked on the skin to en

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Muscle Biomechanical Properties (Muscle Relaxation Time)

    Mechanical stress relaxation time (R) will be measured using the MyotonPRO to assess the time the muscle takes to return to rest following deformation. Results will be reported in milliseconds (ms). Measurements will be taken three times for each muscle segment, and the average value will be calculated. Standardized anatomical landmarks were used for each muscle: Gastrocnemius: measured at the thickest part of the medial head, approximately 10 cm below the popliteal crease. The location was confirmed with a tape measure to account for individual differences. Hamstrings: measured with the participant in a prone position, at the midpoint between the ischial tuberosity and the fibular head. Gluteus maximus: measured at the thickest portion of the muscle identified by palpation while the participant was prone. Erector spinae: measured 2.5 cm lateral to the L5 spinous process in the prone position. Measurement points were marked on the skin to en

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Muscle Biomechanical Properties (Muscle Creep)

    Muscle creep will be assessed as the ratio of relaxation and deformation time (Creep (C)) using the MyotonPRO device. This parameter is a relative unit and indicates viscoelastic behavior of the muscle. Measurements will be taken three times for each muscle segment, and the average value will be calculated. Standardized anatomical landmarks were used for each muscle: Gastrocnemius: measured at the thickest part of the medial head, approximately 10 cm below the popliteal crease. The location was confirmed with a tape measure to account for individual differences. Hamstrings: measured with the participant in a prone position, at the midpoint between the ischial tuberosity and the fibular head. Gluteus maximus: measured at the thickest portion of the muscle identified by palpation while the participant was prone. Erector spinae: measured 2.5 cm lateral to the L5 spinous process in the prone position. Measurement points were marked on the skin to en

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Trunk Endurance Assessment (Sorenson Test)

    Sorenson Test: Participants lay prone with their pelvis at the table edge and ankles secured. They held their upper body in a horizontal position, and the time they could maintain the position was recorded. The test ended when the participant could no longer keep the trunk horizontal.

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Trunk Endurance Assessment (Sit-up Test)

    Sit-up Test: Participants sat with knees flexed at 90° and their upper body positioned at a 60° angle. Arms were crossed over the chest. Time was recorded until the participant's upper body dropped below the 60° angle.

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Trunk endurance assessment (Side Bridge Test-Right and Left)

    Participants lay on their side and lifted their hips to form a straight line with the torso. The duration they could maintain this position was recorded. The test was performed on both sides.

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

Secondary Outcomes (3)

  • Muscle Strength

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Dynamic balance performance

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Vertical jump test

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

Other Outcomes (3)

  • Creatine Kinase

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Pain pressure threshold

    Baseline, 24 hours post-DOMS, 48 hours post-DOMS, and 72 hours post-DOMS

  • Physical Activity Level (IPAQ-Short Form)

    Baseline only (assessed once before the DOMS protocol)

Study Arms (1)

DOMS Induction Arm

EXPERIMENTAL

Participants in this arm will complete a standardized exercise protocol designed to induce delayed onset muscle soreness (DOMS) in the gastrocnemius muscle. All assessments will be performed at baseline, immediately after the DOMS protocol, and at 24, 48, and 72 hours.

Other: Gastrocnemius DOMS Induction Protocol

Interventions

Participants will complete an eccentric exercise protocol to safely induce delayed onset muscle soreness (DOMS) in the gastrocnemius muscle. The protocol includes: Exercise performed bilaterally, starting with the dominant leg Three sets of eccentric heel-lowering movements A 5-minute rest period between sets Participants place the foot on a step and lower the heel for 3 seconds using eccentric contraction The heel is lowered until no further downward motion is possible The opposite leg is used only to lift the body back to the starting position in 1 second A metronome set to 60 beats per minute is used to control movement speed Each set ends when the participant can no longer maintain the required tempo Participants are instructed to avoid physical activity and not take any pain-relieving medication during the 72-hour follow-up period. Intervention Model Description: All participants receive the same DOMS induction protocol.

DOMS Induction Arm

Eligibility Criteria

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

You may qualify if:

  • The study included 14 volunteers aged 18-25 with a resting heart rate between 50 and 90 beats per minute who were right-handed.

You may not qualify if:

  • Individuals who had undergone lower extremity injury or surgery in the past six months were excluded from the study. Those with chronic lower extremity pain or systemic or neurological diseases were also excluded. Participants with vision or hearing problems that could affect balance were excluded. Individuals who regularly used medication, smoked, consumed alcohol, or used other harmful substances were also excluded. Participants who regularly used caffeine or vitamin C supplements or who had an exercise habit were also excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University Topkapi Campus, Maltepe, Teyyareci Sami St. No:3,

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (1)

  • Baird MF, Graham SM, Baker JS, Bickerstaff GF. Creatine-kinase- and exercise-related muscle damage implications for muscle performance and recovery. J Nutr Metab. 2012;2012:960363. doi: 10.1155/2012/960363. Epub 2012 Jan 11.

    PMID: 22288008BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

December 10, 2025

First Posted

January 7, 2026

Study Start

December 20, 2022

Primary Completion

March 20, 2025

Study Completion

April 25, 2025

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

IPD will not be shared because the ethics approval for this study does not allow external sharing of participant data, even in de-identified form.

Locations