Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000085370
Ethics application status
Approved
Date submitted
24/12/2007
Date registered
14/02/2008
Date last updated
14/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of gender in the cardiovascular autonomic responses and cardiorespiratory capacity before and after an aerobic physical training
Scientific title
Autonomics and cardiorespiratories improvements in middle age men and women in response to aerobic physical training
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
middle age men and women clinically healthy, sedentary (at least 6 months without any physical training) 2657 0
Aging 2818 0
prevention of chronic cardiovascular diseases such as hypertension 2832 0
Condition category
Condition code
Cardiovascular 2776 2776 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aerobic Physical Training, during 12 weeks, 3 times a week, 60 minutes each session , intensity between 70 and 85 of the maximal heart rate.
Intervention code [1] 2399 0
Prevention
Comparator / control treatment
the study uses as comparator the initial condition of the volunteers: sedentary (pre training) condition
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3663 0
Improvements of autonomic and cardiorespiratory systems by aerobic physical training.
Timepoint [1] 3663 0
The volunteers were evaluated pre training and after 12 weeks of training
Primary outcome [2] 3834 0
rest heart rate and arterial blood pressure by non invasive methods (eletrocardiography and esphygmomanometry)
Timepoint [2] 3834 0
before start the training protocol and after 12 weeks of training
Secondary outcome [1] 6187 0
comparison between genders (arterial blood pressure, the values of autonomic indicators, cardiorespiratry capacity)
Timepoint [1] 6187 0
The volunteers were evaluated pre training and after 12 weeks of training
Secondary outcome [2] 6462 0
'Aerobic capacity was measured by a cycle ergometer protocol with gas analysys during the effort, until exaustion'
Timepoint [2] 6462 0
before start the training protocol and after 12 weeks of training

Eligibility
Key inclusion criteria
clinically healthy (by cardiological exams), at least 6 months without any physical training practice, the women must take hormonal therapy replacement.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
volunteers that were practicing regular physical and / or who had the clinical evaluation and / or laboratory tests or any other condition that would complicadores risk factors to the practice of regular physical activity proposal, such as: coronary artery disease, hypertension, diabetes, chronic obstructive pulmonary disease, or who were using any medications that interfere in physiological responses to the tests.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
we do not study a control group
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 715 0
Brazil
State/province [1] 715 0
Campinas/SP

Funding & Sponsors
Funding source category [1] 2915 0
Government body
Name [1] 2915 0
Conselho Nacional de Pesquisa (CNPq)
Country [1] 2915 0
Brazil
Primary sponsor type
University
Name
Faculdade e Educação Física Unicamp
Address
Rua Erico Verissimo, 701 - Cidade Universitaria - Campinas
Country
Brazil
Secondary sponsor category [1] 2633 0
Individual
Name [1] 2633 0
Mara Patricia Traina Chacon Mikahil
Address [1] 2633 0
Rua Erico Verissimo, 701 - Cidade Universitaria - Campinas
Country [1] 2633 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Compare cardiovascular responses to Tilt and cardiorespiratory capacity in men and women in middle age before and after aerobic physical training. It is hypotesized that men have higher parassimpathetic modulation in heart rate control than women
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28261 0
Address 28261 0
Country 28261 0
Phone 28261 0
Fax 28261 0
Email 28261 0
Contact person for public queries
Name 11418 0
Mara Patrícia Traina Chacon Mikahil
Address 11418 0
Rua Erico Verissimo, 701 - Cidade Universitaria - Campinas
Country 11418 0
Brazil
Phone 11418 0
55 19 35216625
Fax 11418 0
Email 11418 0
marapatricia@fef.unicamp.br
Contact person for scientific queries
Name 2346 0
Mara Patrícia Traina Chacon Mikahil
Address 2346 0
Rua Erico Verissimo, 701 - Cidade Universitaria - Campinas
Country 2346 0
Brazil
Phone 2346 0
55 19 35216625
Fax 2346 0
Email 2346 0
marapatricia@fef.unicamp.br

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.