Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000872235
Ethics application status
Approved
Date submitted
3/10/2009
Date registered
7/10/2009
Date last updated
7/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects Of Strength Training On Cardiac Autonomic Control In Elderly
Scientific title
Effects Of Strength Training On Cardiac Autonomic Control In Elderly
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy: trained and non trained elderly people (above 60 years old) 251959 0
healthy people, aging, trained and non-trained 251962 0
Condition category
Condition code
Cardiovascular 252145 252145 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
compare the two different group using the holter metodology for cardiac autonomic control analysis (24hour eletrocardiogram monitorization). The volunteers come to the lab and the equipament (holter) is installed on the subject, staying with the holter for 24hours. The next day the subject come back to the lab to desinstall the equipament. The data is recorded during the 24 hour by a memory card for further analysis. This procedure is done just one time. It is a cross sectional study.
The two groups studied are: Group 1: non active men (at least 6 months without practioning any physical activity); Group 2: men who had participated of a 16week strength training offerd by our lab.
Intervention code [1] 241371 0
Prevention
Comparator / control treatment
non active versus trained people.
Group 1 - non active men: at least 6 months without practioning any physical activity;
Group 2 - trained men: men who had participated of a 16week strength training offerd by our lab.
Control group
Active

Outcomes
Primary outcome [1] 253020 0
trained group has a more acurate parasimpathetic cardiac control than the non active group assessed by a holter exam (24 hour eletrocardiogram)
Timepoint [1] 253020 0
in the evaluation period (it is a cross sectinal study)
Secondary outcome [1] 257842 0
Nil
Timepoint [1] 257842 0
nil

Eligibility
Key inclusion criteria
clinically healthy (by cardiological exams), at least 6 months without any physical training practice, for non active group, and trained in the strength training protocol proposed by us in the last 16 weeks.
Minimum age
60 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
volunteers 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
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
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] 2220 0
Brazil
State/province [1] 2220 0

Funding & Sponsors
Funding source category [1] 243835 0
Government body
Name [1] 243835 0
Conselho Nacional de Pesquisa (CNPq)
Country [1] 243835 0
Brazil
Primary sponsor type
University
Name
Faculdade de Educacao Fisica Unicamp
Address
Avenida Erico Verissimo, 701 - Cidade Universitaria Zeferino Vaz - Barao Geraldo
Post Code: 13.083-851 - Campinas - Sao Paulo - Brasil - PO Box 6134
Country
Brazil
Secondary sponsor category [1] 237181 0
Individual
Name [1] 237181 0
Mara Patricia Traina Chacon Mikahil
Address [1] 237181 0
Avenida Erico Verissimo, 701 - Cidade Universitaria Zeferino Vaz - Barao Geraldo
Post Code: 13.083-851 - Campinas - Sao Paulo - Brasil - PO Box 6134
Country [1] 237181 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Compare cardiovascular responses to holter (24-h eletrocardiogram) in trained and non active elderly men. It is hypotesized that trained men have higher parassimpathetic modulation in heart rate control than untrained.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30354 0
Address 30354 0
Country 30354 0
Phone 30354 0
Fax 30354 0
Email 30354 0
Contact person for public queries
Name 13601 0
Mara Patricia Traina Chacon Mikahil
Address 13601 0
Avenida Erico Verissimo, 701 - Cidade Universitaria Zeferino Vaz - Barao Geraldo
Post Code: 13.083-851 - Campinas - Sao Paulo - Brasil - PO Box 6134
Country 13601 0
Brazil
Phone 13601 0
55 19 35217493
Fax 13601 0
Email 13601 0
[email protected]
Contact person for scientific queries
Name 4529 0
Sabrina Toffoli Leite
Address 4529 0
Avenida Erico Verissimo, 701 - Cidade Universitaria Zeferino Vaz - Barao Geraldo
Post Code: 13.083-851 - Campinas - Sao Paulo - Brasil - PO Box 6134
Country 4529 0
Brazil
Phone 4529 0
55 19 35217493
Fax 4529 0
Email 4529 0
[email protected]

No information has been provided regarding IPD availability


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.