Cognitive Function 1, SocialPhase 4NCT02304731
Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects
A Phase 4 study testing Physical Exercise in people with Cognitive Function 1, Social, run by Federal University of São Paulo.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function 1, Social
- What is being tested?
- Physical Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects.
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).
Read the 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.
- Conditions
- Cognitive Function 1, Social
- Being tested
- Physical Exercise
- Keywords
- Physical Exercise, Atmospheric Pollution, Cognition.
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Incremental running
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Pollution Groups | Experimental | Physical Exercise performed in a clean environment and in a polluted environment. Receives: Other: Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Benefits
Neuropsychological Tests applied at the beginning and at the end of protocol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function 1, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Luciana Caxa, Federal University of São Paulo
- Investigators
- Luciana Caxá, Master, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304731
- Sponsor's protocol ID
- UFSao Paulo
- Status last verified
- Nov 2014
- First submitted
- 27 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects.
- ClinicalTrials.gov ID
- NCT02304731
- Acronym / sponsor ID
- UFSao Paulo
- Conditions
- Cognitive Function 1, Social
- Keywords
- Physical Exercise, Atmospheric Pollution, Cognition.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise and Pollution Groups | Experimental | Other: Physical ExercisePhysical Exercise performed in a clean environment and in a polluted environment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExerciseIncremental running | Other | Exercise and Pollution Groups |
Primary outcome
Cognitive Benefits
Time frame: 12 weeks
Neuropsychological Tests applied at the beginning and at the end of protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Caxá, Master study chair
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physical Exercise in people with Cognitive Function 1, Social, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Benefits (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.