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Muscle DamageNCT04733911

Recovery Kinetics Following Eccentric Exercise

A study testing 75 eccentric contractions, 150 eccentric contractions and 300 eccentric contractions in people with Muscle Damage, run by University of Thessaly at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study will be to investigate the recovery kinetics of neuromuscular fatigue, muscle microtrauma indicators, performance and oxidative stress factors after three different exercise induced muscle damage (EIMD) protocols in adult Males. 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
Muscle Damage
What is being tested?
75 eccentric contractions, 150 eccentric contractions and 300 eccentric contractions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteGreece
Study dates
1 Apr 2021to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

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

  • Aged between 18 and 30 years
  • Body Mass Index between 18.5-24.9 kg/m*m
  • Free of chronic diseases
  • Free of musculoskeletal injury
  • participants should be non-smokers

Who cannot join

  • Musculoskeletal injury
  • Chronic disease
  • Use of alcohol, caffeine and any type of nutritional supplements or medication before (≥ 6 months) and throughout the study.

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • University o Thessaly, School of Physical Education and Sports Science

    Trikala, 42100

Other trials in Greece

About this study

Official title: Recovery Kinetics Following Three Exercise-induced Muscle Damage Protocols in Adult Males

The aim of this study will be to investigate the recovery kinetics of neuromuscular fatigue, muscle microtrauma indicators, performance and oxidative stress factors after three different exercise induced muscle damage (EIMD) protocols in adult Males. Also, this study will determine the comparison among three different eccentric protocols in neuromuscular fatigue, muscle microtrauma indicators, performance and oxidative stress factors. The eccentric protocols will be differentiated in training volume and specifically in the eccentric repetitions in isokinetic dynamometer.

Read the detailed description

It is known that eccentric exercise induces muscle microtrauma. Also, eccentric type of exercise are associated with inflammatory response. The leukocytes and the immune cells during the phagocytosis process alter the redox status causing secondary muscle damage to the muscle tissue and also increase oxidative stress concentration. Despite of the existence of studies that examine the muscle damage indicators, inflammatory response, performance and neuromuscular fatigue and oxidative stress concentrations after eccentric exercise, however no studies are detected in order to compare the differences among three eccentric protocols. The eccentric protocols will be differentiated in training volume and specifically in the eccentric repetitions in isokinetic dynamometer. Specifically, a randomized, fourth-trial, cross-over, repeated measures design will be applied. Healthy male adults (age 18-30 years) will participate in the present study. Also, it is considered necessary that the participants will not suffer from any musculoskeletal injuries that will limit their ability to perform the exercise protocols. Also the participants will not be smokers and will not consume alcohol and nutritional supplements.

In the first phase all participants will sign an informed consent form after they will be informed about all benefits and risks of this study and they will sign a recent historical of musculoskeletal injury or illness form. Subsequently, fasting blood samples will be collected by venipuncture using a disposable needle (20-gauge) in order to measure muscle damage markers (CK), inflammation markers (WBC) and oxidative stress markers (TBARS, PC, GSH, ΤΑC, CAT, UA). After, delayed onset muscle soreness (DOMS) in the knee flexors (KF) and extensors (KE) of both limbs, body weight (BW), height and body composition (DXA method) will be measured in the lab. Completing the first phase, participants will be instructed by a dietitian how to record a 5 days diet recalls estimating the energy intake during the trials will be the same. The knee range of motion (KJRM) will be determined by the use of a goniometer, 24 hours after (second phase). The counter movement jump (CMJ) will be evaluated on a force platform using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the data for each leg. During the CMJ will be measured the jump height (cm), the ground reaction force (N), the peak and mean power (W/kg), the vertical stiffness (Kvert, N/m/kg) and the peak rate of force development (RFD, N/s), while at the same time will be evaluated the change in peak and mean normalized EMG during the eccentric and concentric phases of the counter movement jump, for the vastus medialis (VM) and vastus lateralis muscles. Electromyography data will be collected wirelessly at 2.000 Hz using a Myon MA-320 EMG system. The peak eccentric and concentric isokinetic torque of the knee flexors and extensors, in both limbs will be evaluated on an isokinetic dynamometer at 60°/sec. Also, the isometric peak torque of the knee extensors will be evaluated at 65° in both limbs. Finally, Open-circuit spirometry will be utilized for assessment of maximal oxygen consumption (VO2max) using an automated online pulmonary gas exchange system via breath-by-breath analysis during a graded exercise testing on a treadmill.

96 hours after, the participants are going to perform one of the three eccentric protocols randomly, on an isokinetic dynamometer. The eccentric protocol will be performed on a different limb for each trial. The ECC 75 trial will include 75 eccentric maximum repetitions (5 sets, 15 reps/set and recovery period: 30sec.) at 60°/sec. The ECC 150 trial will include 150 eccentric maximum repetitions (10 sets, 15 reps/set and recovery period: 30sec.) at 60°/sec. The ECC 300 trial will include 300 eccentric maximum repetitions (20 sets, 15 reps/set and recovery period: 30sec.) at 60°/sec. The DOMS indicator in the knee flexors (KF) and extensors (KE) of both limbs and the KJRM will be evaluated immediately after each protocol. Also, the (CMJ) will be evaluated on a force platform using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the data for each leg. During the CMJ will be measured the jump height (cm), the ground reaction force (N), the peak and mean power (W/kg), the vertical stiffness (Kvert, N/m/kg) and the peak rate of force development (RFD, N/s), while at the same time will be evaluated the change in peak and mean normalized EMG during the eccentric and concentric phases of the counter movement jump, for the vastus medialis (VM) and vastus lateralis muscles. Electromyography data will be collected wirelessly at 2.000 Hz using a Myon MA-320 EMG system. In addition, the peak eccentric and concentric isokinetic torque of the knee flexors and extensors, in both limbs will be evaluated on an isokinetic dynamometer at 60o/sec. Also, the isometric peak torque of the knee extensors will be evaluated at 65o in both limbs. All the above markers will be evaluated 24, 48 and 192 hours post eccentric protocol, however at these time points, fasting blood samples (20ml) will be collected in order to estimate hematological and biochemical indicators. Α 2 - week washout period will be adapted among trials. After, the participants will perform the process until they complete the trials.

Conditions
Muscle Damage
Being tested
75 eccentric contractions, 150 eccentric contractions, 300 eccentric contractions
Keywords
muscle damage, oxidative stress, Eccentric exercise, Neuromuscular fatigue, Recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 75 eccentric contractionsOther

    An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 5 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.

  • 150 eccentric contractionsOther

    An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 10 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.

  • 300 eccentric contractionsOther

    An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 20 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.

Study groups in NCT04733911
Study groupRoleWhat they receive
Eccentric 75ExperimentalParticipants in this arm will perform an eccentric exercise protocol consisted of 75 eccentric repetetions on an isokinetic dynamometer.
Receives: Other: 75 eccentric contractions
Eccentric 150ExperimentalParticipants in this arm will perform an eccentric exercise protocol consisted of 150 eccentric repetetions on an isokinetic dynamometer.
Receives: Other: 150 eccentric contractions
Eccentric 300ExperimentalParticipants in this arm will perform an eccentric exercise protocol consisted of 300 eccentric repetetions on an isokinetic dynamometer.
Receives: Other: 300 eccentric contractions
ControlNo interventionParticipants in this arm will receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in white blood cell count

    White blood cell count will be measured using an automatic blood analyzer

    Measured: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.

  2. Change in catalase activity

    Concentration of catalase will be measured in red blood cells

    Measured: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.

  3. Change in uric acid in plasma

    concentration of uric acid will be measured in plasma

    Measured: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.

  4. Change in protein carbonyls in blood

    Concentration of protein carbonyls will be measured in red blood cells

    Measured: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.

  5. Change in total antioxidant capacity

    total antioxidant capacity will be measured in serum

    Measured: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.

  6. Change in reduced glutathione in blood

    Concentration of oxidized glutathione will be measured in red blood cells

    Measured: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.

  7. Change in thiobarbituric acid reactive substances

    Thiobarbituric acid will be measured in plasma

    Measured: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.

  8. Change in Creatine kinase in blood

    Creatine kinase will be measured in plasma

    Measured: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.

  9. Change in countermovement jump height

    Countermovement jump height will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the jump height data for each leg.

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  10. Change in ground reaction force (GRF) during countermovement jump test

    The ground reaction force will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the GRF data for each leg.

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  11. Change in peak power during countermovement jump test

    The peak power will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the peak power data for each leg.

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  12. Change in mean power during countermovement jump test

    The mean power will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the mean power data for each leg.

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  13. Change in vertical stifness during countermovement jump test

    The vertical stiffness will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of vertical stifness data for each leg.

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  14. Change in peak rate of force develpemnt during countermovement jump test

    The Peak rate of force development will be measured using two force platforms at 1000 Hz, with each foot in parallel on the two platforms providing a separate yet time-synchronized measurement of the Peak RFD data for each leg.

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  15. Change in peak normalized EMG during the eccentric and concentric phases of the counter movement jump

    Electromyography data will be collected wirelessly at 2.000 Hz using a Myon MA-320 EMG system (Myon AG, Schwarzenberg, Switzerland) for the vastus medialis (VM) and vastus lateralis muscles.

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  16. Change in mean normalized EMG during the eccentric and concentric phases of the counter movement jump

    Electromyography data will be collected wirelessly at 2.000 Hz using a Myon MA-320 EMG system (Myon AG, Schwarzenberg, Switzerland) for the vastus medialis (VM) and vastus lateralis muscles.

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  17. Change in knee range of motion

    Knee range of motion will be measured by goniometer

    Measured: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.

  18. Change in eccentric isokinetic knee extensors peak torque

    Eccentric isokinetic knee extensors peak torque will be assessed on an isokinetic dynamometer

    Measured: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.

  19. Change in concentric isokinetic knee extensors peak torque

    Concentric isokinetic knee extensors peak torque will be assessed on an isokinetic dynamometer

    Measured: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.

  20. Change in eccentric isokinetic knee flexors peak torque

    Eccentric isokinetic knee flexors peak torque will be assessed on an isokinetic dynamometer

    Measured: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.

  21. Change in concentric isokinetic knee flexors peak torque

    Concentric Iisokinetic knee flexors peak torque will be assessed on an isokinetic dynamometer

    Measured: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.

  22. Change in isometric peak torque

    The isometric peak torque will be assessed on an isokinetic dyanmometer

    Measured: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.

  23. Change in fatigue index of isometric torque during 10 second

    Fatigue rate during MVIC will be estimated through the percent drop of peak torque between the first and the last three seconds of a 10-secong maximal isometric contraction.

    Measured: At baseline, 1hour, at 24, 48 and 192 hours following the eccentric exercise protocol.

  24. Change in delayed onset of muscle soreness (DOMS) in the knee flexors (KF) and extensors (KE) of both limbs

    Muscle soreness (KF and KE) will be assessed during palpation of the muscle belly and the distal region

    Measured: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.

Secondary outcomes (5)
  1. Body weight

    Body weight will be measured on a beam balance with stadiometer

    Measured: At baseline

  2. Body height

    Body height will be measured on a beam balance with stadiometer

    Measured: At baseline

  3. Body fat

    Body fat will be measured by using Dual-emission X-ray absorptiometry

    Measured: At baseline

  4. Dietary intake

    Dietary intake will be assessed using 5 -day diet recalls

    Measured: Over a 5 -day period at baseline

  5. Maximal oxygen consumption (VO2max)

    Maximal oxygen consumption will be measured by open circuit spirometry via breath by breath method

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start1 Apr 2021
  3. Primary completion28 Feb 2022
  4. Study completion30 Apr 2022

Resources

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
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04733911
Sponsor's protocol ID
Recovery-Eccentrics-UTH
Status last verified
Jun 2022
First submitted
25 Jan 2021
Last updated
10 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 75 eccentric contractions, 150 eccentric contractions and 300 eccentric contractions in people with Muscle Damage, run by University of Thessaly 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jun 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in white blood cell count (time frame: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Jun 2022.

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