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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01314573
Other study ID # BIOSCI-10-007
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 11, 2011
Last updated March 11, 2011
Start date March 2011
Est. completion date November 2012

Study information

Verified date March 2011
Source University of Leeds
Contact Karen M Birch, BSc PhD
Phone +44(0)1133436713
Email k.m.birch@leeds.ac.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date November 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United Kingdom University of Leeds Leeds West Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal oxygen uptake A measure of aerobic capacity determined during an incremental exercise test to volitional fatigue on an exercise ergometer. 4 weeks Yes
Secondary Heart rate variability 4 weeks No
Secondary Endothelial progenitor cell function measures of in vitro cell migratory ability, adhesion and classification of endothelial progenitor cells 4 weeks No
Secondary Flow mediated dialtion Measure of vascular endothelial function determined non-invasively at the brachial artery 4 weeks No
Secondary 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. 4 weeks Yes
Secondary 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. 4 weeks No
Secondary Endothelial progenitor cell function Measure of in vitro migratory, adhesion and classification of endothelial progenitor cells. 4 weeks No