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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Leeds.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Leeds
ClinicalTrials.gov Identifier:
NCT01314573
First received: March 11, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 Intervention
Exercise Anaphylaxis
 Behavioral: Sprint interval exercise
Behavioral: Maximal continuous exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Maximal oxygen uptake [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    A measure of aerobic capacity determined during an incremental exercise test to volitional fatigue on an exercise ergometer.


Secondary Outcome Measures:
  • Heart rate variability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Endothelial progenitor cell function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    measures of in vitro cell migratory ability, adhesion and classification of endothelial progenitor cells

  • Flow mediated dialtion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measure of vascular endothelial function determined non-invasively at the brachial artery

  • Arterial stiffness [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Circulating angiogenic cell numbers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Endothelial progenitor cell function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measure of in vitro migratory, adhesion and classification of endothelial progenitor cells.


Estimated Enrollment: 12
Study Start Date: March 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314573

Contacts
Contact: Karen M Birch, BSc PhD +44(0)1133436713 k.m.birch@leeds.ac.uk
Contact: Mark Rakobowchuk, BSc MSc PhD +44(0)1133431669 m.e.rakobowchuk@leeds.ac.uk

Locations
United Kingdom
University of Leeds Not yet recruiting
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Contact: Karen M Birch, BSc PhD     +44(0)1133436713     k.m.birch@leeds.ac.uk    
Contact: Mark Rakobowchuk, BSc MSc PhD     +44(0)1133431669     m.e.rakobowchuk@leeds.ac.uk    
Sponsors and Collaborators
University of Leeds
Investigators
Principal Investigator: Karen M Birch, BSc PhD University of Leeds
  More Information

No publications provided

Responsible Party: Dr. Karen Birch, University of Leeds, Sport and Exercise Science
ClinicalTrials.gov Identifier: NCT01314573     History of Changes
Other Study ID Numbers: BIOSCI-10-007
Study First Received: March 11, 2011
Last Updated: March 11, 2011
Health Authority: United Kingdom: Research Ethics Committee

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:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013