Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001037897
Ethics application status
Approved
Date submitted
27/09/2012
Date registered
27/09/2012
Date last updated
27/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect that moderate exercise has on the cardiovascular function in sedentary, overweight adults
Scientific title
The effect of perceptually-regulated exercise training on cerebrovascular reactivity function and flow-mediated dilatation in sedentary, overweight adults
Secondary ID [1] 281313 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obese 287525 0
sedentary 287526 0
Condition category
Condition code
Cardiovascular 287848 287848 0 0
Other cardiovascular diseases
Diet and Nutrition 287849 287849 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 week exercise program of 3 times a week, 30 mins per session at a moderate intensity (RPE 13).
The participant will be walking/jogging on a treadmill at a maximum of "somewhat hard". They will be supervised by gym staff who are either qualified exercise physiologists or Human Movement students/graduates.
Intervention code [1] 285775 0
Lifestyle
Intervention code [2] 285776 0
Treatment: Other
Intervention code [3] 285777 0
Prevention
Comparator / control treatment
no exercise for the same period. Maintaining the current exercise and dietary behaviours.
Control group
Active

Outcomes
Primary outcome [1] 288070 0
Flow mediated dilatation of the brachial artery - B Mode ultrasound, GE Logiq 7
Timepoint [1] 288070 0
baseline (week 0) and post intervention (week 8)
Primary outcome [2] 288071 0
Cerebrovascular reactivity of the middle cerebral artery - Multigon Transcranial Doppler sonography
Timepoint [2] 288071 0
baseline (week 0) and post intervention (week 8)
Secondary outcome [1] 299372 0
VO2 max using the modified Balke-Ware graded exercise test with online gas analysis
Timepoint [1] 299372 0
baseline (week 0) and post intervention (week 8)

Eligibility
Key inclusion criteria
30-55 years old
sedentary (exercise less than 30 mins 3 x p/w at a moderate intensity)
BMI 25-40
Minimum age
30 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cardiovascular or respiratory disease
diabetes
pregnant or lactating
smoking or within 1 year of quitting
any other factors preventing exercise
medications affecting cardiovascular function

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the subject is screened using the ESSA adult pre-exercise questionnaire. If fitting within criteria and gives consent then they will be randomly allocated (via stratification) to either the intervention or control group.
allocation will be done by a person not involved in screening or testing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified randomisation based on age, gender and BMI. Randomisation will be done in microsoft excel by a non-involved person in testing and data analysis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286067 0
University
Name [1] 286067 0
University of South Australia
Country [1] 286067 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
251-261 North Terrace, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 284884 0
None
Name [1] 284884 0
Address [1] 284884 0
Country [1] 284884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288119 0
Human Research Ethics Committee
Ethics committee address [1] 288119 0
251-261 North Terrace, Adelaide, South Australia, 5000
Ethics committee country [1] 288119 0
Australia
Date submitted for ethics approval [1] 288119 0
Approval date [1] 288119 0
12/09/2012
Ethics approval number [1] 288119 0
0000030272

Summary
Brief summary
We are looking at the effects of exercise compared to no exercise on the cardiovascular function in the peripheral (arm) and cerebral (head) arteries.
We expect to see a change in the peripheral and cerebral arteries from exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34767 0
Address 34767 0
Country 34767 0
Phone 34767 0
Fax 34767 0
Email 34767 0
Contact person for public queries
Name 18014 0
Kendall Morrison
Address 18014 0
251-261 North Terrace, Adelaide, South Australia, 5000
Country 18014 0
Australia
Phone 18014 0
+61 8 8302 2287
Fax 18014 0
Email 18014 0
[email protected]
Contact person for scientific queries
Name 8942 0
Kendall Morrison
Address 8942 0
251-261 North Terrace, Adelaide, South Australia, 5000
Country 8942 0
Australia
Phone 8942 0
+61 8 8302 2287
Fax 8942 0
Email 8942 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.