Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12610000091000
Ethics application status
Not yet submitted
Date submitted
25/01/2010
Date registered
27/01/2010
Date last updated
27/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
effect of vascular disease on leg blood flow during exercise
Scientific title
Exercise and leg blood flow in peripheral arterial disease
Secondary ID [1] 1338 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peripheral arterial disease 256674 0
Condition category
Condition code
Cardiovascular 256831 256831 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A small group of patients and control subjects will perform calf exercise and the responses of leg blood flow, oxygenation and fatigue will be studied. Calf exercise involves performing five minutes of intermittent contractions of the calf muscle on a custom-built exercise device. Leg blood flow will be measured non-invasively using venous occlusion plethysmography. Oxygen levels in the medial gastrocnemius and soleus muscles will be measured non-invasively using near-infrared spectroscopy. Measurements of surface electromyopgraphic activity will be used to investigate muscle fatigue. The duration of the study will be approximately two years.
Intervention code [1] 255902 0
Not applicable
Comparator / control treatment
healthy age-matched subjects will serve as controls
Control group
Active

Outcomes
Primary outcome [1] 257687 0
Leg blood flow is the primary dependent variable of interest. Leg blood flow will be assessed in both legs using venous occlusion plethysmography.
Timepoint [1] 257687 0
At the end of this observational study - at two years.
Secondary outcome [1] 263039 0
None
Timepoint [1] 263039 0
None

Eligibility
Key inclusion criteria
peripheral arterial disease (patient group)
no peripheral arterial disease (control)
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
comorbid conditions, such as uncontrolled hypertension, coronary artery disease and pulmonary disease

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
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] 2438 0
New Zealand
State/province [1] 2438 0

Funding & Sponsors
Funding source category [1] 256389 0
Government body
Name [1] 256389 0
Heart Foundation (NZ)
Country [1] 256389 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Cumberland St
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 251704 0
None
Name [1] 251704 0
Address [1] 251704 0
Country [1] 251704 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258457 0
Ethics committee address [1] 258457 0
Ethics committee country [1] 258457 0
Date submitted for ethics approval [1] 258457 0
01/02/2010
Approval date [1] 258457 0
Ethics approval number [1] 258457 0

Summary
Brief summary
Vascular disease of the lower limbs leads to calf muscle pain and fatigue during walking. This results in a failure to sustain even the mildest physical effort involving the legs and reduces the tolerance of walking profoundly, a major problem that requires urgent treatment. However, the physiological causes of this loss of exercise tolerance are not clear, and in this respect there is even considerable doubt about the importance of blood flow to the legs because it hasn’t been carefully studied. For the first time, this preliminary study will examine the effect that vascular disease in the lower limbs has on the response of blood flow into the legs during a well-controlled exercise task. We will also assess how this blood flow response affects the supply of oxygen to, and pain and fatigue of, the contracting muscles. This information will help scientists and medical specialists design better treatments for vascular disease of the lower limbs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30765 0
Address 30765 0
Country 30765 0
Phone 30765 0
Fax 30765 0
Email 30765 0
Contact person for public queries
Name 14012 0
Simon Green
Address 14012 0
Department of Physiology
270 Great King St
University of Otago
Dunedin 9054
Country 14012 0
New Zealand
Phone 14012 0
0064 3 4794861
Fax 14012 0
Email 14012 0
[email protected]
Contact person for scientific queries
Name 4940 0
Simon Green
Address 4940 0
Department of Physiology
270 Great King St
University of Otago
Dunedin 9054
Country 4940 0
New Zealand
Phone 4940 0
0064 3 4794861
Fax 4940 0
Email 4940 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.