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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02082600
Other study ID # 2010070050
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 6, 2014
Last updated March 10, 2014
Start date July 2013

Study information

Verified date March 2014
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Associação Fundo de Incentivo à PesquisaBrazil: National Health Surveillance AgencyBrazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 31 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Sleep deprivation
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.
Normal sleep
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.

Locations

Country Name City State
Brazil Associação Fundo de Incentivo à Pesquisa Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
Federal University of São Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Area Under Curve for serum pro and anti-inflammatory cytokines Blood samples will be collected every 4 hours, for 24 hours. No
Primary Change from baseline in isometric strength Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage No
Secondary Area Under Curve for serum total and free testosterone, IGF-1, and cortisol Blood samples will be collected every 2 hours, for 24 hours. No
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