NCT02082600

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

March 6, 2014

Last Update Submit

March 10, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in isometric strength

    Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage

Secondary Outcomes (1)

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

    Blood samples will be collected every 2 hours, for 24 hours.

Other Outcomes (1)

  • Area Under Curve for serum pro and anti-inflammatory cytokines

    Blood samples will be collected every 4 hours, for 24 hours.

Study Arms (2)

Sleep deprivation

EXPERIMENTAL

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

Other: Sleep deprivation

Normal sleep

EXPERIMENTAL

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

Other: Normal sleep

Interventions

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.

Also known as: Sleep and muscle recovery
Sleep deprivation

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.

Normal sleep

Eligibility Criteria

Age20 Years - 31 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects
  • sedentary
  • sleep duration between 6-8 hours peer night

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associação Fundo de Incentivo à Pesquisa

São Paulo, São Paulo, 04020-050, Brazil

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Sleep

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marco Tulio Mello, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 10, 2014

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations