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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil | OTHER |
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
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Although the effects of acute alcohol intake and sleep deprivation on exercise performance lacks evidence in the literature, in many situations, they occur simultaneously. Once the alcohol affects physiological processes, the processes that occur during sleep can be impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM sleep. These changes promote a significant functional impairment such as a reduction in alertness and modification in reaction time, which affects the performance of any activity of daily and professional life. However, the combined effects on the physical performance variables, such as aerobic and neuromuscular performance lack of evidence in the literature.
Ten subjects were randomized in four situations after familiarization and control situation: (1) alcohol intake combined with sleep normal; (2) alcohol intake combined with sleep deprivation; (3) placebo intake combined with sleep normal and (4) placebo intake combined with sleep deprivation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol intake | Placebo Comparator | 1 g/kg of etanol combined. Beer without alcohol in the same volume will be used to placebo condition. |
|
| sleep deprivation | Active Comparator | one night of sleep deprivation will be compared to 8h of normal sleep. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol intake | Other | The subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic Performance | Aerobic performance will be determined through the subject's heart rate | After each sequence, up to 8 hours |
| Neuromuscular Performance | knee extensor isometric torque | After each sequence, up to 8 hours |
| Biochemical Responses | Glucose after each situation in the morning | After each sequence, up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hydration Status | Urine Specific Gravity | After each sequence, up to 8 hours |
| Profile of Mood States | 6 months | |
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Inclusion Criteria:
- Physical active men
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Rodrigues, MSc | Federal University of Rio Grande do Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise Research Laboratory | Porto Alegre | Rio Grande do Sul | 90690200 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | This is a cross-over study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Received Alcohol intake + Normal Sleep Received Alcohol intake + Sleep Deprivation Received Placebo intake + Normal Sleep Received Placebo intake + Sleep Deprivation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aerobic Performance | Aerobic performance will be determined through the subject's heart rate | Posted | Mean | Standard Deviation | bpm | After each sequence, up to 8 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcohol Intake + Normal Sleep | 1 g/kg of etanol combined with 8 hours of normal sleep |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marco Aurélio Vaz | Federal University of Rio Grande do Sul | 555133085860 | marcovaz@esef.ufrgs.br |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Sleep deprivation | Other | One night of sleep deprivation or one night of normal sleep. |
|
| Breath Alcohol |
| 6 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| maximal oxygen uptake | Mean | Standard Deviation | ml.kg-1.min-1 |
|
| Sequence 3 |
Placebo intake + Normal Sleep Placebo intake: The subjects will be drink beer (zero alcohol) before sleep. Normal sleep: One night of normal sleep (8h) |
| OG003 | Sequence 4 | Placebo intake + Sleep deprivation Placebo intake: The subjects will be drink beer (zero alcohol) before sleep. Sleep deprivation: One night of sleep deprivation (8h) |
|
|
| Primary | Neuromuscular Performance | knee extensor isometric torque | Posted | Mean | Standard Deviation | Nm | After each sequence, up to 8 hours |
|
|
|
| Primary | Biochemical Responses | Glucose after each situation in the morning | Posted | Mean | Standard Deviation | mg/dl | After each sequence, up to 8 hours |
|
|
|
| Secondary | Hydration Status | Urine Specific Gravity | Posted | Mean | Standard Deviation | g/ml | After each sequence, up to 8 hours |
|
|
|
| Secondary | Profile of Mood States | Not Posted | 6 months | Participants |
| Secondary | Breath Alcohol | Not Posted | 6 months | Participants |
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | Alcohol Intake + Sleep Deprivation | 1 g/kg of etanol combined with 8 hours of sleep deprivation | 0 | 10 | 8 | 10 |
| EG002 | Placebo Intake + Normal Sleep | Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep | 0 | 10 | 0 | 10 |
| EG003 | Placebo Intake + Sleep Deprivation | Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation | 0 | 10 | 3 | 10 |
| Headache | Nervous system disorders |
|
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| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |