- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02082600
Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage
March 10, 2014 updated by: 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 04020-050
- Associação Fundo de Incentivo à Pesquisa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 31 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
Other Names:
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Experimental: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in isometric strength
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area Under Curve for serum total and free testosterone, IGF-1, and cortisol
Time Frame: 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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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area Under Curve for serum pro and anti-inflammatory cytokines
Time Frame: 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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 6, 2014
First Submitted That Met QC Criteria
March 6, 2014
First Posted (Estimate)
March 10, 2014
Study Record Updates
Last Update Posted (Estimate)
March 11, 2014
Last Update Submitted That Met QC Criteria
March 10, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010070050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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