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

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

Study Contact Backup

Study Locations

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:
  • 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.
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:
  • high intensity exercise training

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.

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

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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