- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07503860
Indirect Biomarkers and Exercise Induced Muscle Damage
March 26, 2026 updated by: Vassilis Paschalis
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
48
Phase
- 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
-
-
Attica
-
Athens, Attica, Greece, 17237
- Department of Physical Education and Sport Science, National and Kapodistrian University of Athens
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy, physically active, males
Exclusion Criteria:
- Musculoskeletal injuries, chronic diseases, smoking, consumption of any sports/antioxidant supplements or medication, and potential inflammatory conditions
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Initial bout of isokinetic eccentric exercise
Isokinetic eccentric exercise will be performed, while before and 48h after a number of indirect biomarkers will be assessed
|
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.
|
|
Experimental: Subsequent bout of isokinetic eccentric exercise
Isokinetic eccentric exercise will be performed, while before and 48h after a number of indirect biomarkers will be assessed
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 48 hours 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.
|
Baseline and 48 hours 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.
|
Baseline and 48 hours 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.
|
Baseline and 48 hours 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.
|
Baseline and 48 hours 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.
|
Baseline and 48 hours after the eccentric exercise bout.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Panayiotou 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.
- 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.
- Methenitis 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.
- Paschalis 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.
- Margaritelis 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.
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)
August 22, 2025
Primary Completion (Actual)
November 27, 2025
Study Completion (Estimated)
July 15, 2026
Study Registration Dates
First Submitted
February 11, 2026
First Submitted That Met QC Criteria
March 26, 2026
First Posted (Actual)
March 31, 2026
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 26, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 1858/03-10-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared because participant consent did not include public data sharing and the dataset size increases re-identification risk.
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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