Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000578000
Ethics application status
Approved
Date submitted
13/07/2010
Date registered
19/07/2010
Date last updated
19/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Establishing appropriate exercise prescriptions for hypertensive subjects: What can ergospirometry tell us?
Scientific title
Non-medicated hypertensive adults submitted to 3 month mild aerobic training did not change the oxygen consumption (VO2) - heart rate (HR) relationship and the anaerobic threshold.
Secondary ID [1] 252083 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension 257630 0
Condition category
Condition code
Cardiovascular 257806 257806 0 0
Hypertension
Physical Medicine / Rehabilitation 257826 257826 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 months of mild aerobic exercise program: Program sessions were offered Monday through Friday (participants attended three sessions per week), with each session consisting of a 5-minute stretching warm-up, 40 to 50 minutes of jogging (heart rate and velocity associated with 50 to 70% of his/her maximal oxygen consumption-VO2max prior to beginning program) and a 5-minute cool-down. Exercise intensity (treadmill speed) was controlled by heart rate using Polar cardiac monitor. Each session was conducted on a treadmill and supervised by physical therapist
Intervention code [1] 256708 0
Lifestyle
Intervention code [2] 256800 0
Treatment: Other
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258786 0
Ergospirometric parameters (VO2, volume of carbonic gas (VCO2), ventilation (VE), and respiratory exchange rate (RER)) measured continuously during an incremental treadmill test to exhaustion. The anaerobic threshold (AT) was determined by ventilatory techniques during the ergospirometry test. The electrocardiogram was used to monitor heart rate (HR) throughout the test. VO2-HR relationship has not changed after training
Timepoint [1] 258786 0
this outcome was also assessed at baseline and 3 months from baseline when the intervention treatment has ended
Secondary outcome [1] 264850 0
Nil
Timepoint [1] 264850 0
Nil

Eligibility
Key inclusion criteria
sedentary non-medicated adult hypertensives
There is no inclusion criterion related to body weight
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
incapacity for physical activity, non-controlled hypertension
diabetes, coronary heart disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
non-medicated hypertensives followed in Hypertension and Metabolism Research Center at the Medical School of Marilia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2710 0
Brazil
State/province [1] 2710 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257277 0
Government body
Name [1] 257277 0
Foundation for Research of the State of Sao Paulo
Country [1] 257277 0
Brazil
Primary sponsor type
University
Name
Higher School Bureau of Sao Paulo State, Marilia School of Medicine
Address
Monte Carmelo 800
Marilia
Sao Paulo
Zip Code 17519-030
Country
Brazil
Secondary sponsor category [1] 256525 0
Other Collaborative groups
Name [1] 256525 0
Hypertension and Metabolism Research Center at the Medical School of Marilia
Address [1] 256525 0
Comendador Fragata 825
Marilia
Sao Paulo
Zip Code 17519-020
Country [1] 256525 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259286 0
Research Ethics Committee at the Medical School of Marilia
Ethics committee address [1] 259286 0
Ethics committee country [1] 259286 0
Brazil
Date submitted for ethics approval [1] 259286 0
Approval date [1] 259286 0
30/06/2006
Ethics approval number [1] 259286 0

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

Contacts
Principal investigator
Name 31326 0
Address 31326 0
Country 31326 0
Phone 31326 0
Fax 31326 0
Email 31326 0
Contact person for public queries
Name 14573 0
Carolina Zancheta Nogueira
Address 14573 0
rua Comendador Fragata, 825
Marilia - Sao Paulo
Zip Code 17519020
Country 14573 0
Brazil
Phone 14573 0
+55 14 34321173
Fax 14573 0
+55 14 34321173
Email 14573 0
carolina@famema.br
Contact person for scientific queries
Name 5501 0
Paulo Henrique Waib
Address 5501 0
rua Comendador Fragata, 825
Marilia - Sao Paulo
Zip Code 17519020
Country 5501 0
Brazil
Phone 5501 0
+55 14 34321173
Fax 5501 0
+55 14 34321173
Email 5501 0
waib@unimedmarilia.com.br

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.