NCT04733911

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

January 25, 2021

Last Update Submit

June 7, 2022

Conditions

Keywords

muscle damageoxidative stressEccentric exerciseNeuromuscular fatigueRecovery

Outcome Measures

Primary Outcomes (24)

  • Change in white blood cell count

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

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

  • Change in catalase activity

    Concentration of catalase will be measured in red blood cells

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

  • Change in uric acid in plasma

    concentration of uric acid will be measured in plasma

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

  • Change in protein carbonyls in blood

    Concentration of protein carbonyls will be measured in red blood cells

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

  • Change in total antioxidant capacity

    total antioxidant capacity will be measured in serum

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

  • Change in reduced glutathione in blood

    Concentration of oxidized glutathione will be measured in red blood cells

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

  • Change in thiobarbituric acid reactive substances

    Thiobarbituric acid will be measured in plasma

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

  • Change in Creatine kinase in blood

    Creatine kinase will be measured in plasma

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • Change in knee range of motion

    Knee range of motion will be measured by goniometer

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

  • Change in eccentric isokinetic knee extensors peak torque

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

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

  • Change in concentric isokinetic knee extensors peak torque

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

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

  • Change in eccentric isokinetic knee flexors peak torque

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

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

  • Change in concentric isokinetic knee flexors peak torque

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

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

  • Change in isometric peak torque

    The isometric peak torque will be assessed on an isokinetic dyanmometer

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

  • 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.

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

  • 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

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

Secondary Outcomes (5)

  • Body weight

    At baseline

  • Body height

    At baseline

  • Body fat

    At baseline

  • Dietary intake

    Over a 5 -day period at baseline

  • Maximal oxygen consumption (VO2max)

    At baseline

Study Arms (4)

Eccentric 75

EXPERIMENTAL

Participants in this arm will perform an eccentric exercise protocol consisted of 75 eccentric repetetions on an isokinetic dynamometer.

Other: 75 eccentric contractions

Eccentric 150

EXPERIMENTAL

Participants in this arm will perform an eccentric exercise protocol consisted of 150 eccentric repetetions on an isokinetic dynamometer.

Other: 150 eccentric contractions

Eccentric 300

EXPERIMENTAL

Participants in this arm will perform an eccentric exercise protocol consisted of 300 eccentric repetetions on an isokinetic dynamometer.

Other: 300 eccentric contractions

Control

NO INTERVENTION

Participants in this arm will receive no intervention.

Interventions

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.

Eccentric 75

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.

Eccentric 150

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.

Eccentric 300

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University o Thessaly, School of Physical Education and Sports Science

Trikala, 42100, Greece

Location

Study Officials

  • Ioannis G Fatouros, Prof

    University of Thessaly

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 2, 2021

Study Start

April 1, 2021

Primary Completion

February 28, 2022

Study Completion

April 30, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Locations