- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04733911
Recovery Kinetics Following Eccentric Exercise
Recovery Kinetics Following Three Exercise-induced Muscle Damage Protocols in Adult Males
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Tríkala, Řecko, 42100
- University o Thessaly, School of Physical Education and Sports Science
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- Musculoskeletal injury
- Chronic disease
- Use of alcohol, caffeine and any type of nutritional supplements or medication before (≥ 6 months) and throughout the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Žádný zásah: Řízení
Účastníci v této větvi neobdrží žádný zásah.
|
|
Experimentální: Eccentric 75
Participants in this arm will perform an eccentric exercise protocol consisted of 75 eccentric repetetions on an isokinetic dynamometer.
|
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.
|
Experimentální: Eccentric 150
Participants in this arm will perform an eccentric exercise protocol consisted of 150 eccentric repetetions on an isokinetic dynamometer.
|
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.
|
Experimentální: Eccentric 300
Participants in this arm will perform an eccentric exercise protocol consisted of 300 eccentric repetetions on an isokinetic dynamometer.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in white blood cell count
Časové okno: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, at 1 hour and 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, 1hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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
Časové okno: At baseline, 1 hour, at 24, 48 and 192 hours following the eccentric exercise protocol.
|
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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Tělesná hmotnost
Časové okno: Na základní linii
|
Tělesná hmotnost bude měřena na paprskové váze se stadiometrem
|
Na základní linii
|
Výška těla
Časové okno: Na základní linii
|
Tělesná výška bude měřena na paprskové váze se stadiometrem
|
Na základní linii
|
Tělesný tuk
Časové okno: Na základní linii
|
Tělesný tuk bude měřen pomocí dvouemisní rentgenové absorbometrie
|
Na základní linii
|
Dietary intake
Časové okno: Over a 5 -day period at baseline
|
Dietary intake will be assessed using 5 -day diet recalls
|
Over a 5 -day period at baseline
|
Maximální spotřeba kyslíku (VO2max)
Časové okno: Na základní linii
|
Maximální spotřeba kyslíku bude měřena spirometrií na otevřeném okruhu metodou dýchání dech
|
Na základní linii
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Recovery-Eccentrics-UTH
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na 75 eccentric contractions
-
Massachusetts General HospitalDokončenoPorucha pozornosti s hyperaktivitouSpojené státy
-
NIZO Food ResearchFrieslandCampinaDokončeno
-
University of Roma La SapienzaZatím nenabíráme
-
Ruijin-Hainan Hospital Shanghai Jiao Tong University...Nábor
-
Livzon Pharmaceutical Group Inc.NeznámýAzoospermie | OligospermieČína
-
Ramathibodi HospitalDokončeno
-
Mayo ClinicPfizerZatím nenabíráme
-
Mayo ClinicNational Center for Advancing Translational Sciences (NCATS)Nábor
-
Federal University of São PauloUniversity of Sao PauloJiž není k dispozici
-
University of Missouri-ColumbiaMedtronicDokončenoZlomeniny, uzavřenoSpojené státy