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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02082600
• Other study ID #: 2010070050
• 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. 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

• Sleep
• Sleep Deprivation

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