Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000026325
Ethics application status
Approved
Date submitted
10/01/2008
Date registered
18/01/2008
Date last updated
18/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anaerobic threshold obtained by heart rate response and heart rate variability in cycle ergometer and treadmill
Scientific title
Anaerobic threshold obtained by heart rate response and heart rate variability during discontinuous dynamic physical exercise test carry out in cycle ergometer and in treadmill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaerobic threshold by heart rate response 2694 0
Step discontinuous dynamic physical exercise test 2695 0
Condition category
Condition code
Cardiovascular 2812 2812 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To compare the anaerobic threshold and heart rate response in the step discontinuous dynamic physical exercise test in cycle ergometer and treadmill. The study had the duration of one year (01/08/2005 to 31/07/2006).
Intervention code [1] 2430 0
Not applicable
Intervention code [2] 2464 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3698 0
Anaerobic threshold obtained for heart rate response during dynamic exercise carry out in cycle ergometer and carry out in treadmill
Timepoint [1] 3698 0
The anaerobic threshold was measured straight after the the subjects had already participated in program of cardiac rehabilitation (approximately 6 to 5 years on average)
Secondary outcome [1] 6243 0
To compare the anaerobic threshold and the heart rate variability in the dynamic exercise carry out in cycle ergometer and carry out in treadmill in a group of subjects with coronary heart disease
Timepoint [1] 6243 0
The protocol (cycle or treadmill) was applied so randomized with an interval of one week at least between them. The comparisons were made after the data's collection

Eligibility
Key inclusion criteria
The subjects should have coronary artery disease or coronary artery disease risk factors
Minimum age
54 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects no submitted in a program of cardiovascular physical therapy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 726 0
Brazil
State/province [1] 726 0
Sao Paulo/Sao Carlos

Funding & Sponsors
Funding source category [1] 2946 0
Government body
Name [1] 2946 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (National Council for Scientific and Technological Development)
Country [1] 2946 0
Brazil
Primary sponsor type
University
Name
Federal University of Sao Carlos
Address
Rodovia Washington Luis km 235
Universidade Federal de São Carlos
Laboratório de Fisioterapia Cardiovascular - Núcleo de Pesquisa em Exercício Físico
Country
Brazil
Secondary sponsor category [1] 2659 0
None
Name [1] 2659 0
Address [1] 2659 0
Country [1] 2659 0
Secondary sponsor category [2] 2688 0
Individual
Name [2] 2688 0
Aparecida Maria Catai
Address [2] 2688 0
Rodovia Washington Luis km 235 Universidade Federal de S?o Carlos Laborat?rio de Fisioterapia Cardiovascular - N?cleo de Pesquisa em Exerc?cio F?sico
Country [2] 2688 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4889 0
Ethics Committe of research in humans, Federal University of Sao Carlos
Ethics committee address [1] 4889 0
Ethics committee country [1] 4889 0
Brazil
Date submitted for ethics approval [1] 4889 0
27/03/2006
Approval date [1] 4889 0
14/06/2006
Ethics approval number [1] 4889 0
125/2006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28284 0
Address 28284 0
Country 28284 0
Phone 28284 0
Fax 28284 0
Email 28284 0
Contact person for public queries
Name 11441 0
Aparecida Maria Catai
Address 11441 0
Rodovia Washington Luis km 235 Universidade Federal de São Carlos Laboratório de Fisioterapia Cardiovascular - Núcleo de Pesquisa em Exercício Físico
Country 11441 0
Brazil
Phone 11441 0
16 33518705
Fax 11441 0
16 33612081
Email 11441 0
[email protected]
Contact person for scientific queries
Name 2369 0
Aparecida Maria Catai
Address 2369 0
Rodovia Washington Luis km 235 Universidade Federal de São Carlos Laboratório de Fisioterapia Cardiovascular - Núcleo de Pesquisa em Exercício Físico
Country 2369 0
Brazil
Phone 2369 0
16 33518705
Fax 2369 0
16 33612081
Email 2369 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.