- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01314573
The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women
March 11, 2011 updated by: University of Leeds
The purpose of the study is to examine the effects of different exercise intensity training programs upon blood vessel function and circulating blood cells involved in blood vessel repair in young women.
The long term effects of exercise may be beneficial to cardiovascular health and it is important to understand the training methods that are the most beneficial.
In particular we aim to determine if brief maximal exercise improves the function and stiffness of blood vessels and enhance blood vessel repair.
Two methods of exercising are being compared, exercise bouts involving intermittent exercise and exercise completed all at once, but at a very high intensity.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karen M Birch, BSc PhD
- Phone Number: +44(0)1133436713
- Email: k.m.birch@leeds.ac.uk
Study Contact Backup
- Name: Mark Rakobowchuk, BSc MSc PhD
- Phone Number: +44(0)1133431669
- Email: m.e.rakobowchuk@leeds.ac.uk
Study Locations
-
-
West Yorkshire
-
Leeds, West Yorkshire, United Kingdom, LS2 9JT
- University of Leeds
-
Contact:
- Karen M Birch, BSc PhD
- Phone Number: +44(0)1133436713
- Email: k.m.birch@leeds.ac.uk
-
Contact:
- Mark Rakobowchuk, BSc MSc PhD
- Phone Number: +44(0)1133431669
- Email: m.e.rakobowchuk@leeds.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Young healthy females
- Between 18-25 years old
- No on medication (this includes contraceptives)
Exclusion Criteria:
- Medication use (including oral contraceptives)
- Amenorrhoea
- High blood pressure
- Very active (>3 hours per week of organized physical activity)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interval maximal exercise
Interval exercise involving repeated Wingate tests (30s durations of maximal exercise on a cycle ergometer).
|
3 session per week of exercise on a exercise cycle ergometer.
Each session involves 30s of maximal exercise followed by 4.5 min of easy cycling at 10W.
This is repeated 4 times at each exercise session.
Other Names:
|
Experimental: Continuous maximal exercise
Continuous exercise of maximal exertion that has been work matched to an initial bout of interval exercise of 4 x 30s of maximal exercise.
This exercise is performed on a cycle ergometer.
|
3 sessions per week of an exercise intervention involving maximal cycling until the participant has completed an amount of work equivalent to a sprint interval training session.
This exercise lasts between 3 and 3.5 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal oxygen uptake
Time Frame: 4 weeks
|
A measure of aerobic capacity determined during an incremental exercise test to volitional fatigue on an exercise ergometer.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability
Time Frame: 4 weeks
|
4 weeks
|
|
Endothelial progenitor cell function
Time Frame: 4 weeks
|
measures of in vitro cell migratory ability, adhesion and classification of endothelial progenitor cells
|
4 weeks
|
Flow mediated dialtion
Time Frame: 4 weeks
|
Measure of vascular endothelial function determined non-invasively at the brachial artery
|
4 weeks
|
Arterial stiffness
Time Frame: 4 weeks
|
The stiffness of the carotid artery is measured using a combination of ultrasound imaging and non-invasive blood pressure measurements.
Lower degrees of stiffness are more favourable.
|
4 weeks
|
Circulating angiogenic cell numbers
Time Frame: 4 weeks
|
These cells are involved in vascular repair and proliferation and may be measured using flow cytometric methods.
Specifically cells with CD34 and CD309 antigens are enumerated.
|
4 weeks
|
Endothelial progenitor cell function
Time Frame: 4 weeks
|
Measure of in vitro migratory, adhesion and classification of endothelial progenitor cells.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen M Birch, BSc PhD, University of Leeds
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
September 1, 2012
Study Completion (Anticipated)
November 1, 2012
Study Registration Dates
First Submitted
March 11, 2011
First Submitted That Met QC Criteria
March 11, 2011
First Posted (Estimate)
March 14, 2011
Study Record Updates
Last Update Posted (Estimate)
March 14, 2011
Last Update Submitted That Met QC Criteria
March 11, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIOSCI-10-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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