Neuropsychological Sleep Physical Exercise Hypoxia (Hypoxia)
Primary Purpose
Hypoxia
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Hypoxia
Eligibility Criteria
Inclusion Criteria:Be physically active (perform aerobic exercise at least three times a week for at least 1 year);
- Minimum age 12 years school;
- Intelligence quotient ≥ 80.
Exclusion Criteria:Present health problems (as assessed by cardiac and respiratory care) and those that do not allow the practice of exercise;
- Present changes in resting electrocardiogram and effort and in clinical evaluation conducted by the Medical Center for Psychobiology and Exercise;
- Being a smoker and / or using drugs of abuse;
- Make use of psychotropic medications;
- Make use of alcoholic beverages frequently;
- Display sleep disorders
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01386814
First Posted
June 30, 2011
Last Updated
June 30, 2011
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01386814
Brief Title
Neuropsychological Sleep Physical Exercise Hypoxia
Acronym
Hypoxia
Official Title
Aspects of Neuropsychological Assessment, Standard and Sleep Efficiency in People Exposed to Altitude
Study Type
Observational
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: To evaluate the influence of oxygen deficit on the cognitive performance and also about the architecture and sleep efficiency in volunteers subjected to mild and moderate exercise in a hypobaric chamber. SUMMARY: Participants in this study 30 healthy male volunteers, aged 20 to 40 years, regular physical activity, constituting three groups: 1 - without exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise in hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of 10 volunteers who will undergo a protocol exercise physical sea-level, 3 - group exercise and hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the same in condition of hypoxia (hypobaric chamber). All groups on the first day of the experiment will undergo baseline assessments, laboratory blood analysis salivary and spirometric testing. Assessments will be personality and neuropsychological. After baseline assessments, the last day of the experiment, the groups will be evaluated again 4350m above sea level the sea, by personality tests, neuropsychological and laboratory. RATIONALE AND BACKGROUND: During exposure to environments with a partial reduction of oxygen, human body can undergo several physiological and psychological changes are not prepared for such condition. Few studies have reported that the elevation changes and cognitive aspects related to sleep.
MATERIAL AND METHOD: They describe the procedures to be performed, and the study conducted in local with adequate infrastructure.
Detailed Description
ADDITIONAL RISKS TO THE PATIENT: Minimal risk, mild discomfort, involving blood collect. Purpose: To evaluate the influence of oxygen deficit on the cognitive performance and also about the architecture and sleep efficiency in volunteers subjected to mild and moderate exercise in a hypobaric chamber.
SUMMARY: Participants in this study 30 healthy male volunteers, aged 20 to 40 years, regular physical activity, constituting three groups: 1 - without exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise in hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of 10 volunteers who will undergo a protocol exercise physical sea-level, 3 - group exercise and hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the same in condition of hypoxia (hypobaric chamber). All groups on the first day of the experiment will undergo baseline assessments, laboratory blood analysis salivary and spirometric testing. Assessments will be personality and neuropsychological. After baseline assessments, the last day of the experiment, the groups will be evaluated again 4350m above sea level the sea, by personality tests, neuropsychological and laboratory. RATIONALE AND BACKGROUND: During exposure to environments with a partial reduction of oxygen, human body can undergo several physiological and psychological changes are not prepared for such condition. Few studies have reported that the elevation changes and cognitive aspects related to sleep
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
7. Study Design
Enrollment
60 (Anticipated)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Be physically active (perform aerobic exercise at least three times a week for at least 1 year);
Minimum age 12 years school;
Intelligence quotient ≥ 80.
Exclusion Criteria:Present health problems (as assessed by cardiac and respiratory care) and those that do not allow the practice of exercise;
Present changes in resting electrocardiogram and effort and in clinical evaluation conducted by the Medical Center for Psychobiology and Exercise;
Being a smoker and / or using drugs of abuse;
Make use of psychotropic medications;
Make use of alcoholic beverages frequently;
Display sleep disorders
Study Population Description
Participants in this study 30 healthy male volunteers, aged 20 to 40 years, regular physical activity, constituting three groups: 1 - without exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise in hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of 10 volunteers who will undergo a protocol exercicio physical sea-level, 3 - group exercise and hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the same in condition of hypoxia. All groups on the first day of the experiment will undergo baseline assessments, laboratory blood analysis salivary and spirometric testing.
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valdir A Lemos, DR
Phone
551155720177
Email
aquino.lemos@unifesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco T Mello, Dr
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Neuropsychological Sleep Physical Exercise Hypoxia
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