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Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects

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ClinicalTrials.gov Identifier: NCT02304731
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : December 2, 2014
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Luciana Caxa, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE November 27, 2014
First Posted Date  ICMJE December 2, 2014
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE February 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2014)
Cognitive Benefits [ Time Frame: 12 weeks ]
Neuropsychological Tests applied at the beginning and at the end of protocol
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects
Official Title  ICMJE Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects.
Brief Summary Modern society increasingly seeks healthy life style, and regular physical activity is considered one of the main factors that improve the quality of life. The evidence shows that the aerobic physical training in controlled environments benefit various aspects of human health, including cognition in the elderly population. However, when exercise is performed in a polluted environment, the individual is subjected to grater exposure to pollutants due to increased ventilation (breathing).
Detailed Description Modern society increasingly seeks healthy life style, and regular physical activity is considered one of the main factors that improve the quality of life. The evidence shows that the aerobic physical training in controlled environments benefit various aspects of human health, including cognition in the elderly population. However, when exercise is performed in a polluted environment, the individual is subjected to grater exposure to pollutants due to increased ventilation (breathing). It is well known that inhaled pollutants can cause oxidative modification in biomolecules and oxidative stress is a cause of diverse diseases. This scenario raises important questions: the deleterious effects of pollution can abolish the beneficial effects of exercise? This issue is currently relevant given the increasing level of air pollution in large urban centers such as Sao Paulo city and at the same time, outdoor physical activity in public places is largely stimulated by public organizations, particularly for elderly. Thus this multidisciplinary project aims to investigate the deleterious effects of urban air pollution in elderly people who practice aerobic physical exercise outdoors in Sao Paulo and compare with those who practice in Laboratory. This study can provide important knowledge for public health and welfare of the population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Cognitive Function 1, Social
Intervention  ICMJE Other: Physical Exercise
Incremental running
Study Arms  ICMJE Experimental: Exercise and Pollution Groups
Physical Exercise performed in a clean environment and in a polluted environment.
Intervention: Other: Physical Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2014)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Health Subjects that lives in São Paulo city for at least 10 years.

-

Exclusion Criteria: Neuropsychological issues.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02304731
Other Study ID Numbers  ICMJE UFSao Paulo
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luciana Caxa, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE University of Sao Paulo
Investigators  ICMJE
Study Chair: Luciana Caxá, Master Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP