NCT01314573

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 14, 2011

Status Verified

March 1, 2011

Enrollment Period

1.5 years

First QC Date

March 11, 2011

Last Update Submit

March 11, 2011

Conditions

Keywords

High intensity exercise trainingVascular healthEndothelial functionCirculating angiogenic cellsendothelial progenitor cellsAerobic capacityArterial stiffnessTraditional and emerging cardiovascular disease risk factors

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake

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

    4 weeks

Secondary Outcomes (6)

  • Heart rate variability

    4 weeks

  • Endothelial progenitor cell function

    4 weeks

  • Flow mediated dialtion

    4 weeks

  • Arterial stiffness

    4 weeks

  • Circulating angiogenic cell numbers

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Interval maximal exercise

EXPERIMENTAL

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

Behavioral: Sprint interval exercise

Continuous maximal exercise

EXPERIMENTAL

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

Interventions

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.

Also known as: high intensity exercise training
Interval maximal 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.

Also known as: high intensity exercise training
Continuous maximal exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young healthy females
  • Between 18-25 years old
  • No on medication (this includes contraceptives)

You may not qualify if:

  • Medication use (including oral contraceptives)
  • Amenorrhoea
  • High blood pressure
  • Very active (\>3 hours per week of organized physical activity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Exercise-Induced Allergies

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Karen M Birch, BSc PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen M Birch, BSc PhD

CONTACT

Mark Rakobowchuk, BSc MSc PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

March 14, 2011

Record last verified: 2011-03

Locations