Working… Menu

The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314573
Recruitment Status : Unknown
Verified March 2011 by University of Leeds.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2011
Last Update Posted : March 14, 2011
Information provided by:
University of Leeds

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Exercise Anaphylaxis Behavioral: Sprint interval exercise Behavioral: Maximal continuous exercise Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women
Study Start Date : March 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: Interval maximal exercise
Interval exercise involving repeated Wingate tests (30s durations of maximal exercise on a cycle ergometer).
Behavioral: Sprint interval exercise
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 Name: high intensity exercise training

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.
Behavioral: Maximal continuous exercise
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 Name: high intensity exercise training

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Heart rate variability [ Time Frame: 4 weeks ]
  2. Endothelial progenitor cell function [ Time Frame: 4 weeks ]
    measures of in vitro cell migratory ability, adhesion and classification of endothelial progenitor cells

  3. Flow mediated dialtion [ Time Frame: 4 weeks ]
    Measure of vascular endothelial function determined non-invasively at the brachial artery

  4. 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.

  5. 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.

  6. Endothelial progenitor cell function [ Time Frame: 4 weeks ]
    Measure of in vitro migratory, adhesion and classification of endothelial progenitor cells.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314573

Layout table for location contacts
Contact: Karen M Birch, BSc PhD +44(0)1133436713
Contact: Mark Rakobowchuk, BSc MSc PhD +44(0)1133431669

Layout table for location information
United Kingdom
University of Leeds
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Contact: Karen M Birch, BSc PhD    +44(0)1133436713   
Contact: Mark Rakobowchuk, BSc MSc PhD    +44(0)1133431669   
Sponsors and Collaborators
University of Leeds
Layout table for investigator information
Principal Investigator: Karen M Birch, BSc PhD University of Leeds
Layout table for additonal information
Responsible Party: Dr. Karen Birch, University of Leeds, Sport and Exercise Science Identifier: NCT01314573    
Other Study ID Numbers: BIOSCI-10-007
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: March 2011
Keywords provided by University of Leeds:
High intensity exercise training
Vascular health
Endothelial function
Circulating angiogenic cells
endothelial progenitor cells
Aerobic capacity
Arterial stiffness
Traditional and emerging cardiovascular disease risk factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity, Immediate
Immune System Diseases