Exercise AnaphylaxisNCT01314573
The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women
A study testing Sprint interval exercise and Maximal continuous exercise in people with Exercise Anaphylaxis, run by University of Leeds at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Anaphylaxis
- What is being tested?
- Sprint interval exercise and Maximal continuous exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young healthy females
- Between 18-25 years old
- No on medication (this includes contraceptives)
Who cannot join
- Medication use (including oral contraceptives)
- Amenorrhoea
- High blood pressure
- Very active (>3 hours per week of organized physical activity)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
Karen M Birch, BSc PhD, +44(0)1133436713, k.m.birch@leeds.ac.uk
Mark Rakobowchuk, BSc MSc PhD, +44(0)1133431669, m.e.rakobowchuk@leeds.ac.uk
About this study
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.
- Conditions
- Exercise Anaphylaxis
- Being tested
- Sprint interval exercise, Maximal continuous exercise
- 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
- Medical subject headings
- Exercise-Induced Allergies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sprint interval exerciseBehavioural
Also called high intensity exercise training
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 exerciseBehavioural
Also called high intensity exercise training
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.
| Study group | Role | What they receive |
|---|---|---|
| Interval maximal exercise | Experimental | Interval exercise involving repeated Wingate tests (30s durations of maximal exercise on a cycle ergometer). Receives: 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. Receives: Behavioral: Maximal continuous exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake
A measure of aerobic capacity determined during an incremental exercise test to volitional fatigue on an exercise ergometer.
Measured: 4 weeks
Secondary outcomes (6)
Heart rate variability
Measured: 4 weeks
Endothelial progenitor cell function
measures of in vitro cell migratory ability, adhesion and classification of endothelial progenitor cells
Measured: 4 weeks
Flow mediated dialtion
Measure of vascular endothelial function determined non-invasively at the brachial artery
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Endothelial progenitor cell function
Measure of in vitro migratory, adhesion and classification of endothelial progenitor cells.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise AnaphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Investigators
- Karen M Birch, BSc PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314573
- Sponsor's protocol ID
- BIOSCI-10-007
- Status last verified
- Mar 2011
- First submitted
- 11 Mar 2011
- Last updated
- 14 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women
- ClinicalTrials.gov ID
- NCT01314573
- Acronym / sponsor ID
- BIOSCI-10-007
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval maximal exercise | Experimental | Behavioral: Sprint interval exerciseInterval exercise involving repeated Wingate tests (30s durations of maximal exercise on a cycle ergometer). |
| Continuous maximal exercise | Experimental | Behavioral: Maximal continuous exerciseContinuous 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Young healthy females
- Between 18-25 years old
- No on medication (this includes contraceptives)
Key exclusion criteria (4 listed)
- Medication use (including oral contraceptives)
- Amenorrhoea
- High blood pressure
- Very active (>3 hours per week of organized physical activity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sprint interval exerciseAlso: high intensity exercise training3 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. | Behavioural | Interval maximal exercise |
| Maximal continuous exerciseAlso: high intensity exercise training3 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. | Behavioural | Continuous maximal exercise |
Primary outcome
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.
6 secondary outcomes
Heart rate variability
Time frame: 4 weeks
Endothelial progenitor cell function
Time frame: 4 weeks
Flow mediated dialtion
Time frame: 4 weeks
Arterial stiffness
Time frame: 4 weeks
Circulating angiogenic cell numbers
Time frame: 4 weeks
Endothelial progenitor cell function
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Birch, BSc PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sprint interval exercise and Maximal continuous exercise in people with Exercise Anaphylaxis, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen M Birch, BSc PhD (+44(0)1133436713, k.m.birch@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen uptake (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2011.