- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07565376
Effects of Exercise-Induced Muscle Damage on Neuromuscular Complexity (EIMD-NMC)
Effects of Exercise-Induced Muscle Damage Induced by Eccentric Exercise on Knee Extensor Torque, Oxygenation, and Electromyographic Properties: A Complexity-Based Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The present study was designed to investigate the impact of exercise-induced muscle damage , caused by eccentric exercise, on neuromuscular and physiological function of the knee extensor muscles. The research was based on the contemporary theoretical framework of the "loss of complexity," which proposes that physiological signal variability is not merely random noise, but rather an essential characteristic of healthy and adaptable biological systems. According to this approach, greater signal complexity reflects a more flexible and efficient neuromuscular control strategy, whereas reduced complexity indicates impaired adaptability and a more rigid functional state.
A total of eleven healthy young men (N = 11, age 27.8 ± 2.5 years) participated in the study. During the initial session, anthropometric characteristics were recorded and maximal voluntary isometric torque of the knee extensors was measured. The main testing procedure involved a sustained submaximal isometric contraction performed at 50% of maximal voluntary contraction for 60 seconds. During this task, torque output, muscle oxygenation, and electromyographic activity of the vastus lateralis were continuously was recorded in order to assess both mechanical and neuromuscular responses.
Following baseline testing, participants completed a muscle damage induction protocol consisting of five sets of fifteen maximal eccentric contractions performed at an angular velocity of 60°/s. This protocol was designed to induce structural and functional muscle impairment characteristic of exercise induced muscle damage. Forty-eight hours after the intervention, all measurements were repeated to determine the effects of muscle damage on the same variables. Data were processed and analyzed in MATLAB, with statistical significance set at p < .05.
The results are anticipated to confirm the successful induction of muscle damage.
The investigators wanted to show the effect of exercise induced muscle damage on torque complexity through changes in Sample Entropy, and changes on detrended fluctuation analysis exponent, which indicate that torque fluctuations will became more regular, predictable, and less complex.
A possible reduction in complexity it expected to be accompanied by a change in neuromuscular efficiency, meaning that a greater level of neural activation will be needed to produce the same relative mechanical output. A likely explanation is that damage to muscle fibers and sarcomeres would reduce the effectiveness of force transmission, forcing the nervous system to compensate through increased neural drive.
In parallel, it is expected that muscle oxygenation measurements will show increased deoxygenated hemoglobin, indicating higher oxygen extraction and a greater metabolic burden on the remaining functional muscle fibers. This finding would suggest that, after exercise induced muscle damage, fewer intact fibers may be available to share the workload, thereby increasing the relative demand placed on those still functioning effectively.
An additional important observation will be the possible changes in traditional linear variability indices, such as standard deviation and coefficient of variation. This will highlight the limitation of conventional linear measures in detecting subtle but functionally meaningful changes in neuromuscular regulation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Attica
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Athens, Attica, Greece, 17234
- School of Physical Education and Sport Science
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- No experience of resistance exercise with heavy loads the past 6 months
Exclusion Criteria:
- History of lower-limb injury
- Taking any medication
- Suffered from any pathological condition
- Participation in a systematic eccentric exercise program during the previous 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eccentric exercise
All the parameters that was assessed 48 hours post isokinetic eccentric exercise
|
Isokinetic eccentric exercise consisted of 5 sets of 15 repetitions using the knee extensors.
The intensity of the exercise was the maximal voluntary and an interval of 1 minute was applied between sets.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isokinetic sub maximal exercise
Time Frame: From enrollment to the end of the treatment at 48 hours
|
Isokinetic exercise of 60 seconds using the sub maximal intensity of 50% MVC.
The knee joint will be set at 90 degrees and the values will be in Nm.
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From enrollment to the end of the treatment at 48 hours
|
|
Electromyography
Time Frame: From enrollment to the end of treatment at 48 hours
|
Continuous recording of EMG during the 60 seconds isometric exercise.
Patches will be placed in vastus laterals and the recording will be at 100 Hz
|
From enrollment to the end of treatment at 48 hours
|
|
Muscle oxygenation
Time Frame: rom enrollment to the end of treatment at 48 hours
|
Muscle oxygenation measured using near infrared spectroscopy (NIRS) of the knee extensors during the 60 seconds isometric exercise.
The main parameters that will be recored are the oxygenated haemoglobin, the deoxygenated haemoglobin, the total haemoglobin and the difference between oxygenated and deoxygenated haemoglobin.
|
rom enrollment to the end of treatment at 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed onset muscle soreness
Time Frame: From enrollment to the end of treatment at 48 hours
|
Assessment of subjective pain feeling assessed by palpation of knee extensors muscle belly.
The scale was set between 1 (no pain at all) to 10 (extreme pain).
|
From enrollment to the end of treatment at 48 hours
|
|
Range of Motion
Time Frame: From enrollment to the end of treatment at 48 hours
|
The angles the knee joint may be flexed without the feeling of any pain.
The starting position was set at full extension.
|
From enrollment to the end of treatment at 48 hours
|
|
Peak torque output
Time Frame: From enrollment to the end of treatment at 48 hours
|
Isometric peak torque output was assessed at 90 degrees knee joint angle (0 degrees was set at full extension).
The assessments was consisted of 3 set of 5 seconds each.
The higher performance was recorded for the data analysis
|
From enrollment to the end of treatment at 48 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vassilis Paschalis, Dr., National and Kapodistrian Univesity of Athens
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1731/19-12-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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