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Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage

Primary Purpose

Sleep, Sleep Deprivation

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sleep deprivation
Normal sleep
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep

Eligibility Criteria

20 Years - 31 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Associação Fundo de Incentivo à Pesquisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleep deprivation

Normal sleep

Arm Description

Exercise induced-muscle damage protocol followed by 60h of sleep deprivation (two nights) and one night of normal sleep (rebound).

Exercise induced-muscle damage protocol followed by 3 nights of normal sleep

Outcomes

Primary Outcome Measures

Change from baseline in isometric strength

Secondary Outcome Measures

Area Under Curve for serum total and free testosterone, IGF-1, and cortisol

Full Information

First Posted
March 6, 2014
Last Updated
March 10, 2014
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02082600
Brief Title
Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage
Official Title
Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Sleep Deprivation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep deprivation
Arm Type
Experimental
Arm Description
Exercise induced-muscle damage protocol followed by 60h of sleep deprivation (two nights) and one night of normal sleep (rebound).
Arm Title
Normal sleep
Arm Type
Experimental
Arm Description
Exercise induced-muscle damage protocol followed by 3 nights of normal sleep
Intervention Type
Other
Intervention Name(s)
Sleep deprivation
Other Intervention Name(s)
Sleep and muscle recovery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal sleep
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in isometric strength
Time Frame
Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage
Secondary Outcome Measure Information:
Title
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.
Other Pre-specified Outcome Measures:
Title
Area Under Curve for serum pro and anti-inflammatory cytokines
Time Frame
Blood samples will be collected every 4 hours, for 24 hours.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Tulio Mello, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associação Fundo de Incentivo à Pesquisa
City
Sao Paulo
ZIP/Postal Code
04020-050
Country
Brazil

12. IPD Sharing Statement

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Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage

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