- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01728675
Eccentric Exercise and Oxidative Stress
13. november 2012 oppdatert av: Dr. Anastasios Theodorou, European University Cyprus
The Effect of Eccentric Exercise on Oxidative Stress in the Elderly
The purpose of the present investigation is to compare the responses and adaptations of young and elderly individuals to repeated eccentric exercise in regards to muscle function and redox homeostasis in a side-by-side comparison.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Despite the progress of analytic techniques and the refinement of study designs, striking disagreement exists among studies regarding the influence of exercise on muscle function and redox homeostasis in the elderly.
A specific exercise protocol will be applied (the repeated eccentric model) to produce long-lasting and extensive changes in redox biomarkers and to examine more easily the potential effects of aging.
Ten young men and ten elderly men will underwent an isokinetic eccentric exercise session, which will be repeated after three weeks.
Muscle function indices and redox biomarkers will be assessed in urine, plasma or erythrocytes pre exercise, immediately post exercise, 2 and 4 days post exercise.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Nicosia, Kypros, 1516
- European University Cyprus
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- subject provides written informed consent
- physiological health profile
- stable at their anthropometric characteristics for at least the last year
Exclusion Criteria:
- muscle disease
- prior history of musculoskeletal injury to the lower limbs
- smokers
- consumed any nutritional supplement the last 3 months
- performed intense eccentric exercise the last 6 months
- non Caucasian
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Young group
Participants will underwent two isokinetic eccentric exercise sessions
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Participants will perform two isokinetic eccentric exercise bouts
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Eksperimentell: Elderly group
Participants will underwent two isokinetic eccentric exercise sessions
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Participants will perform two isokinetic eccentric exercise bouts
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Muscle torque (torque)
Tidsramme: Change in muscle torque from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in muscle torque from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Range of motion, ROM (degrees)
Tidsramme: Change in ROM from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in ROM from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Delayed onset muscle soreness, DOMS (scale 1-10)
Tidsramme: Change in DOMS from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in DOMS from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Creatine kinase, CK (activity IU)
Tidsramme: Change in CK from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in CK from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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F2-isoprostanes (pg/mg creatinine)
Tidsramme: Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Protein carbonyls (nmol/mg protein)
Tidsramme: Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Glutathione, GSH (μmol/g Hb)
Tidsramme: Change in GSH from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in GSH from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Catalase (U/g Hb)
Tidsramme: Change in catalase from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in catalase from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Superoxide dismutase, SOD (U/g Hb)
Tidsramme: Change in SOD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in SOD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Glutathione peroxidase, GPx (U/g Hb)
Tidsramme: Change in GPx from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in GPx from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Glucose-6-phosphate dehydrogenase, G6PD (U/g Hb)
Tidsramme: Change in G6PD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in G6PD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Uric acid (mM)
Tidsramme: Change in uric acid from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in uric acid from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Albumin (μM)
Tidsramme: Change in albumin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in albumin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Bilirubin (μM)
Tidsramme: Change in bilirubin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Change in bilirubin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Michalis G Nikolaidis, PhD, Aristotle University Of Thessaloniki
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Nikolaidis MG, Kyparos A, Vrabas IS. F(2)-isoprostane formation, measurement and interpretation: the role of exercise. Prog Lipid Res. 2011 Jan;50(1):89-103. doi: 10.1016/j.plipres.2010.10.002. Epub 2010 Oct 15.
- Nikolaidis MG, Jamurtas AZ. Blood as a reactive species generator and redox status regulator during exercise. Arch Biochem Biophys. 2009 Oct 15;490(2):77-84. doi: 10.1016/j.abb.2009.08.015. Epub 2009 Aug 25.
- Nikolaidis MG, Kyparos A, Spanou C, Paschalis V, Theodorou AA, Vrabas IS. Redox biology of exercise: an integrative and comparative consideration of some overlooked issues. J Exp Biol. 2012 May 15;215(Pt 10):1615-25. doi: 10.1242/jeb.067470.
- Theodorou AA, Nikolaidis MG, Paschalis V, Sakellariou GK, Fatouros IG, Koutedakis Y, Jamurtas AZ. Comparison between glucose-6-phosphate dehydrogenase-deficient and normal individuals after eccentric exercise. Med Sci Sports Exerc. 2010 Jun;42(6):1113-21. doi: 10.1249/MSS.0b013e3181c67ecd.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2012
Primær fullføring (Faktiske)
1. juli 2012
Studiet fullført (Faktiske)
1. juli 2012
Datoer for studieregistrering
Først innsendt
6. november 2012
Først innsendt som oppfylte QC-kriteriene
13. november 2012
Først lagt ut (Anslag)
20. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. november 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. november 2012
Sist bekreftet
1. november 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- EUC-017
- EUC-019 (Annet stipend/finansieringsnummer: European University Cyprus)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .