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

Primary Purpose

Exercise Anaphylaxis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sprint interval exercise
Maximal continuous exercise
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exercise Anaphylaxis focused on measuring 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

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Leeds

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Interval maximal exercise

Continuous maximal exercise

Arm Description

Interval exercise involving repeated Wingate tests (30s durations of maximal exercise on a cycle ergometer).

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.

Outcomes

Primary Outcome Measures

Maximal oxygen uptake
A measure of aerobic capacity determined during an incremental exercise test to volitional fatigue on an exercise ergometer.

Secondary Outcome Measures

Heart rate variability
Endothelial progenitor cell function
measures of in vitro cell migratory ability, adhesion and classification of endothelial progenitor cells
Flow mediated dialtion
Measure of vascular endothelial function determined non-invasively at the brachial artery
Arterial stiffness
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
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
Measure of in vitro migratory, adhesion and classification of endothelial progenitor cells.

Full Information

First Posted
March 11, 2011
Last Updated
March 11, 2011
Sponsor
University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT01314573
Brief Title
The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women
Official Title
The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Leeds

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Anaphylaxis
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interval maximal exercise
Arm Type
Experimental
Arm Description
Interval exercise involving repeated Wingate tests (30s durations of maximal exercise on a cycle ergometer).
Arm Title
Continuous maximal exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sprint interval exercise
Other Intervention Name(s)
high intensity exercise training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maximal continuous exercise
Other Intervention Name(s)
high intensity exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal oxygen uptake
Description
A measure of aerobic capacity determined during an incremental exercise test to volitional fatigue on an exercise ergometer.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Heart rate variability
Time Frame
4 weeks
Title
Endothelial progenitor cell function
Description
measures of in vitro cell migratory ability, adhesion and classification of endothelial progenitor cells
Time Frame
4 weeks
Title
Flow mediated dialtion
Description
Measure of vascular endothelial function determined non-invasively at the brachial artery
Time Frame
4 weeks
Title
Arterial stiffness
Description
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.
Time Frame
4 weeks
Title
Circulating angiogenic cell numbers
Description
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.
Time Frame
4 weeks
Title
Endothelial progenitor cell function
Description
Measure of in vitro migratory, adhesion and classification of endothelial progenitor cells.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen M Birch, BSc PhD
Phone
+44(0)1133436713
Email
k.m.birch@leeds.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Rakobowchuk, BSc MSc PhD
Phone
+44(0)1133431669
Email
m.e.rakobowchuk@leeds.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Birch, BSc PhD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leeds
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9JT
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen M Birch, BSc PhD
Phone
+44(0)1133436713
Email
k.m.birch@leeds.ac.uk
First Name & Middle Initial & Last Name & Degree
Mark Rakobowchuk, BSc MSc PhD
Phone
+44(0)1133431669
Email
m.e.rakobowchuk@leeds.ac.uk

12. IPD Sharing Statement

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

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