Exercise Induced Muscle DamageNCT07503860
Indirect Biomarkers and Exercise Induced Muscle Damage
A study testing Eccentric Exercise in people with Exercise Induced Muscle Damage, run by Vassilis Paschalis at 1 site in Greece.
Trial summary
The purpose of this study is to investigate the magnitude of changes in biomarkers of exercise-induced muscle damage following an acute bout of eccentric exercise of the knee extensors performed on an isokinetic dynamometer. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Muscle Damage
- What is being tested?
- Eccentric Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGreece
- Study dates
- 22 Aug 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, physically active, males
Who cannot join
- Musculoskeletal injuries, chronic diseases, smoking, consumption of any sports/antioxidant supplements or medication, and potential inflammatory conditions
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physical Education and Sport Science, National and Kapodistrian University of Athens
Athens, Attica, 17237
About this study
Official title: Repeated Bout Effect and Indirect Biomarkers After Eccentric Exercise Induced Muscle Damage
The purpose of this study is to investigate the magnitude of changes in biomarkers of exercise-induced muscle damage following an acute bout of eccentric exercise of the knee extensors performed on an isokinetic dynamometer. Moreover, these biomarkers will be assessed at different time points after the initial intervention, checking the repeated bout effect phenomenon.
Read the detailed description
Volunteers will visit the laboratory a total of two times. During the first visit, in all participants will be assessed indirect markers of exercise-induced muscle damage (i.e., peak torque, delayed-onset muscle soreness, range of motion, rate of force development), blood parameters (i.e., creatine kinase and c-Reactive Protein), and muscle oxygenation using near infrared spectroscopy. Afterwards, participants will perform an eccentric exercise protocol for the knee extensors consisting of 5 sets of 15 maximal-intensity repetitions at an angular velocity of 60°/s. The second visit will be at different time points between participant, where the indirect mauls damage biomarkers will be reassessed before and after the same isokinetic eccentric exercise (i.e., 5 sets of 15 maximal-intensity repetitions at an angular velocity of 60°/s).
- Conditions
- Exercise Induced Muscle Damage
- Being tested
- Eccentric Exercise
- Keywords
- Isokinetics, eccentric exercise, muscle damage, range of motion, delayed onset muscle soreness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric ExerciseOther
Eccentric exercise will be performed using an isokinetic dynamometer. It will be consisted of 5 set of 15 eccentric contraction of the knee extensors at an angular velocity of 60o/s. The intensity will be maximal voluntary.
| Study group | Role | What they receive |
|---|---|---|
| Initial bout of isokinetic eccentric exercise | Experimental | Isokinetic eccentric exercise will be performed, while before and 48h after a number of indirect biomarkers will be assessed Receives: Other: Eccentric Exercise |
| Subsequent bout of isokinetic eccentric exercise | Experimental | Isokinetic eccentric exercise will be performed, while before and 48h after a number of indirect biomarkers will be assessed Receives: Other: Eccentric Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed onset muscle soreness
Pain will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Measured: Baseline and 48 hours after the eccentric exercise bout.
Peak torque output
Peak torque will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Measured: Baseline and 48 hours after the eccentric exercise bout.
Range of Motion
The free pain range of motion will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Measured: Baseline and 48 hours after the eccentric exercise bout.
Muscle oxygenation
Using near infrared spectroscopy, the oxygenation of the knee extensors will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Measured: Baseline and 48 hours after the eccentric exercise bout.
Creatine kinase
Creatine kinase will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Measured: Baseline and 48 hours after the eccentric exercise bout.
Muscle thickness using ultrasound
Participants's knee extensors muscle thickness will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Measured: Baseline and 48 hours after the eccentric exercise bout.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start22 Aug 2025
- Primary completion27 Nov 2025
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vassilis Paschalis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vassilis Paschalis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503860
- Sponsor's protocol ID
- 1858/03-10-2025
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because participant consent did not include public data sharing and the dataset size increases re-identification risk.
Publications
Bobotas V, Chatzinikolaou PN, Methenitis S, Doika E, Spiliopoulou P, Malliou VJ, Mpampoulis T, Terzis G, Geladas N, Paschalis V. The Effect of Exercise-Induced Muscle Damage on Muscle and Cerebral Oxygenation and Performance. Int J Sports Med. 2025 Dec;46(14):1049-1060. doi: 10.1055/a-2644-4923. Epub 2025 Jun 26.
PubMed 40570898Methenitis S, Theodorou AA, Chatzinikolaou PN, Margaritelis NV, Nikolaidis MG, Paschalis V. The effects of chronic concentric and eccentric training on position sense and joint reaction angle of the knee extensors. Eur J Sport Sci. 2023 Jul;23(7):1164-1174. doi: 10.1080/17461391.2023.2184726. Epub 2023 Mar 18.
PubMed 36815692Panayiotou G, Paschalis V, Nikolaidis MG, Theodorou AA, Deli CK, Fotopoulou N, Fatouros IG, Koutedakis Y, Sampanis M, Jamurtas AZ. No adverse effects of statins on muscle function and health-related parameters in the elderly: an exercise study. Scand J Med Sci Sports. 2013 Oct;23(5):556-67. doi: 10.1111/j.1600-0838.2011.01437.x. Epub 2012 Jan 31.
PubMed 22288788Paschalis V, Nikolaidis MG, Giakas G, Jamurtas AZ, Owolabi EO, Koutedakis Y. Position sense and reaction angle after eccentric exercise: the repeated bout effect. Eur J Appl Physiol. 2008 May;103(1):9-18. doi: 10.1007/s00421-007-0663-9. Epub 2008 Jan 3.
PubMed 18172668Margaritelis NV, Theodorou AA, Chatzinikolaou PN, Kyparos A, Nikolaidis MG, Paschalis V. Eccentric exercise per se does not affect muscle damage biomarkers: early and late phase adaptations. Eur J Appl Physiol. 2021 Feb;121(2):549-559. doi: 10.1007/s00421-020-04528-w. Epub 2020 Nov 6.
PubMed 33156414
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Bout Effect and Indirect Biomarkers After Eccentric Exercise Induced Muscle Damage
- ClinicalTrials.gov ID
- NCT07503860
- Acronym / sponsor ID
- 1858/03-10-2025
- Conditions
- Exercise Induced Muscle Damage
- Keywords
- Isokinetics, eccentric exercise, muscle damage, range of motion, delayed onset muscle soreness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vassilis PaschalisUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the magnitude of changes in biomarkers of exercise-induced muscle damage following an acute bout of eccentric exercise of the knee extensors performed on an isokinetic dynamometer. Moreover, these biomarkers will be assessed at different time points after the initial intervention, checking the repeated bout effect phenomenon.
Detailed description
Volunteers will visit the laboratory a total of two times. During the first visit, in all participants will be assessed indirect markers of exercise-induced muscle damage (i.e., peak torque, delayed-onset muscle soreness, range of motion, rate of force development), blood parameters (i.e., creatine kinase and c-Reactive Protein), and muscle oxygenation using near infrared spectroscopy. Afterwards, participants will perform an eccentric exercise protocol for the knee extensors consisting of 5 sets of 15 maximal-intensity repetitions at an angular velocity of 60°/s. The second visit will be at different time points between participant, where the indirect mauls damage biomarkers will be reassessed before and after the same isokinetic eccentric exercise (i.e., 5 sets of 15 maximal-intensity repetitions at an angular velocity of 60°/s).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial bout of isokinetic eccentric exercise | Experimental | Other: Eccentric ExerciseIsokinetic eccentric exercise will be performed, while before and 48h after a number of indirect biomarkers will be assessed |
| Subsequent bout of isokinetic eccentric exercise | Experimental | Other: Eccentric ExerciseIsokinetic eccentric exercise will be performed, while before and 48h after a number of indirect biomarkers will be assessed |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, physically active, males
Key exclusion criteria (1 listed)
- Musculoskeletal injuries, chronic diseases, smoking, consumption of any sports/antioxidant supplements or medication, and potential inflammatory conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric ExerciseEccentric exercise will be performed using an isokinetic dynamometer. It will be consisted of 5 set of 15 eccentric contraction of the knee extensors at an angular velocity of 60o/s. The intensity will be maximal voluntary. | Other | Initial bout of isokinetic eccentric exercise, Subsequent bout of isokinetic eccentric exercise |
Primary outcome
Delayed onset muscle soreness
Time frame: Baseline and 48 hours after the eccentric exercise bout.
Pain will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Peak torque output
Time frame: Baseline and 48 hours after the eccentric exercise bout.
Peak torque will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Range of Motion
Time frame: Baseline and 48 hours after the eccentric exercise bout.
The free pain range of motion will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Muscle oxygenation
Time frame: Baseline and 48 hours after the eccentric exercise bout.
Using near infrared spectroscopy, the oxygenation of the knee extensors will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Creatine kinase
Time frame: Baseline and 48 hours after the eccentric exercise bout.
Creatine kinase will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Muscle thickness using ultrasound
Time frame: Baseline and 48 hours after the eccentric exercise bout.
Participants's knee extensors muscle thickness will be assessed at baseline (before the eccentric exercise bout) and again at 48 hours (2 days) after the eccentric exercise bout.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 40570898Bobotas V, Chatzinikolaou PN, Methenitis S, Doika E, Spiliopoulou P, Malliou VJ, Mpampoulis T, Terzis G, Geladas N, Paschalis V. The Effect of Exercise-Induced Muscle Damage on Muscle and Cerebral Oxygenation and Performance. Int J Sports Med. 2025 Dec;46(14):1049-1060. doi: 10.1055/a-2644-4923. Epub 2025 Jun 26.
- Background: PubMed 36815692Methenitis S, Theodorou AA, Chatzinikolaou PN, Margaritelis NV, Nikolaidis MG, Paschalis V. The effects of chronic concentric and eccentric training on position sense and joint reaction angle of the knee extensors. Eur J Sport Sci. 2023 Jul;23(7):1164-1174. doi: 10.1080/17461391.2023.2184726. Epub 2023 Mar 18.
- Background: PubMed 22288788Panayiotou G, Paschalis V, Nikolaidis MG, Theodorou AA, Deli CK, Fotopoulou N, Fatouros IG, Koutedakis Y, Sampanis M, Jamurtas AZ. No adverse effects of statins on muscle function and health-related parameters in the elderly: an exercise study. Scand J Med Sci Sports. 2013 Oct;23(5):556-67. doi: 10.1111/j.1600-0838.2011.01437.x. Epub 2012 Jan 31.
- Background: PubMed 18172668Paschalis V, Nikolaidis MG, Giakas G, Jamurtas AZ, Owolabi EO, Koutedakis Y. Position sense and reaction angle after eccentric exercise: the repeated bout effect. Eur J Appl Physiol. 2008 May;103(1):9-18. doi: 10.1007/s00421-007-0663-9. Epub 2008 Jan 3.
- Background: PubMed 33156414Margaritelis NV, Theodorou AA, Chatzinikolaou PN, Kyparos A, Nikolaidis MG, Paschalis V. Eccentric exercise per se does not affect muscle damage biomarkers: early and late phase adaptations. Eur J Appl Physiol. 2021 Feb;121(2):549-559. doi: 10.1007/s00421-020-04528-w. Epub 2020 Nov 6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participant consent did not include public data sharing and the dataset size increases re-identification risk.
Related trials for Exercise Induced Muscle Damage
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Active, not recruiting
Effects of Nattokinase Supplementation on Strength Recovery and Muscle Damage Biomarkers Following Exercise-Induced Muscle Injury: A Pilot Study
Exercise-induced Muscle Damage
Recruiting
The Effect of Different rTMS Interventions on Acute Experimental Muscular Pain in Individuals Comorbid With Insomnia
Insomnia, Healthy Adult
Recruiting
Effects of Inter-Set Rest Intervals on Muscle Damage After Flywheel Exercise in Untrained Men (RCT)
Exercise-induced Muscle Damage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Exercise in people with Exercise Induced Muscle Damage, run by Vassilis Paschalis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed onset muscle soreness (time frame: Baseline and 48 hours after the eccentric exercise bout.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503860, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.