- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02082600
Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage
10. marts 2014 opdateret af: Hanna Karen Moreira Antunes, Federal University of São Paulo
The aims of this study are examine the effects of sleep deprivation in muscle recovery after a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24 series of 10 repetitions).
The sample will consist of 10 men, sedentary, clinically healthy, aged between 20 and 31 years old.
Two experimental groups will be developed: EXE-SLEEP, in which subjects will perform the exercise protocol (~18:00-19:00) and will be subject to normal period of sleep for 3 nights; EXE-TOTAL, in which subjects will perform the same exercise protocol and will be sleep deprived for 60 hours, followed by one night of sleep rebound.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The blood parameters analyzed will be:
- Creatine kinase and myoglobin: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol.
- Total and free testosterone, IGF-1, and cortisol: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol. Moreover, from 19:00 of the second day to 19:00 of the third day it will be collected blood samples every 2 hours.
- GH: during the second night, GH will be evaluated every 1 hour, from 23:00 to 07:00.
- TNF-alfa, IL-6, IL-1 beta, IL-10, and IL-1ra: before, immediately after, and 2 hour after exercise, as well every 4 hours from 19:00 of the second day to 19:00 of the third day.
It will be evaluated isometric strength every 12 hours, as well visual analog scale of pain.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sao Paulo, Brasilien, 04020-050
- Associação Fundo de Incentivo à Pesquisa
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 31 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- healthy subjects
- sedentary
- sleep duration between 6-8 hours peer night
Exclusion Criteria:
- smokers
- use vitamin supplements, like C and E
- drink two doses of alcohol/day or > 4 doses in one occasion
- use of anti-inflammatory drugs
- antilipidemic drugs
- anemia
- muscle or joint diseases
- cardiovascular diseases
- diabetes
- renal diseases
- sleep disturbances
- breathing disorders
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Sleep deprivation
Exercise induced-muscle damage protocol followed by 60h of sleep deprivation (two nights) and one night of normal sleep (rebound).
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This group will perform 24 sets of 10 maximum repetitions of eccentric contractions for quadriceps and than will keep awake for 60 hours (2 nights), followed by 1 night of sleep, all inside the lab.
During whole protocol, it will be collected several blood samples for evaluation of hormones, cytokines and muscle damage parameters.
It will be also evaluated isometric strength and pain.
Andre navne:
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Eksperimentel: Normal sleep
Exercise induced-muscle damage protocol followed by 3 nights of normal sleep
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This group will perform 24 sets of 10 maximum repetitions of eccentric contractions for quadriceps and and will be able to sleep the 3 nights.
During whole protocol, it will be collected several blood samples for evaluation of hormones, cytokines and muscle damage parameters.
It will be also evaluated isometric strength and pain.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in isometric strength
Tidsramme: Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage
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Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Area Under Curve for serum total and free testosterone, IGF-1, and cortisol
Tidsramme: Blood samples will be collected every 2 hours, for 24 hours.
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Blood samples will be collected every 2 hours, for 24 hours.
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Area Under Curve for serum pro and anti-inflammatory cytokines
Tidsramme: Blood samples will be collected every 4 hours, for 24 hours.
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Blood samples will be collected every 4 hours, for 24 hours.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2013
Primær færdiggørelse (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
6. marts 2014
Først indsendt, der opfyldte QC-kriterier
6. marts 2014
Først opslået (Skøn)
10. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2010070050
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .