Cardiovascular DiseasePhase 2NCT01219725
Cardiovascular Prophylaxis for Postmenopausal Women
A Phase 2 study testing Exercise training in people with Cardiovascular Disease, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The purpose of this study was to examine the effect of 6 months moderate intensity exercise training completed three times per week upon traditional and emerging cardiovascular disease risk factors in postmenopausal women both with and without type 2 diabetes. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2005to Dec 2011
- Phase
- Phase 2
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy and stable type II diabetic postmenopausal women (cessation of menstrual periods for 12 months and confirmed with LH/FSH samples) aged 45 - 65 years old for the cross sectional analysis and exercise training study.
Who cannot join
- Identified abnormalities during baseline testing.
- Vigorously active women.
- Women who are pregnant.
- Women with serious systemic or psychological disorders (e.g. COPD, asthma, clinical depression).
- Women with known coronary artery disease.
- Women with significant cardiovascular pathologies and associated medication.
Show all 11Show fewer
- Women with type 1 or insulin treated diabetes.
- Women with diabetes with complications.
- Women with unstable diabetes or hypertension.
- Women with any cancer.
- Women with musculoskeletal impairments or contraindications to exercise.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Centre for Sports and Exercise Sciences, University of Leeds
Leeds, West Yorkshire, LS2 9JT
Karen M Birch, BSc, PhD
About this study
Official title: Can a Moderate Intensity Exercise Training Programme Improve Cardiac Function and Known Cardiovascular Risk Factors in Middle-aged Women?
The purpose of this study was to examine the effect of 6 months moderate intensity exercise training completed three times per week upon traditional and emerging cardiovascular disease risk factors in postmenopausal women both with and without type 2 diabetes. These risk factors include blood markers associated with increased risk such as cholesterol, insulin, glucose and markers of inflammation plus measures of body fat, heart and lung fitness, vascular stiffness and vascular function. The study hypothesised that moderate intensity exercise training would intervene in the exaggerated risk seen in women following the menopause, especially in those with type 2 diabetes.
- Conditions
- Cardiovascular Disease
- Being tested
- Exercise training
- Keywords
- Body composition, Endothelial function, Lipoprotein profile, Inflammatory markers, Aerobic capacity, Thrombotic markers, Arterial stiffness, Cardiac function, Traditional and emerging cardiovascular disease risk factors
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
6 months of moderate intensity exercise training 3 times per week
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake
Measured: 6 months
Secondary outcomes (6)
lipoprotein profile
Measured: 6 months
Flow mediated dilation
Measured: 6 months
Cardiac power output
Measured: 6 months
Arterial stiffness
Measured: 6 months
Inflammatory markers
Measured: 6 months
Body composition
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJul 2005
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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
- NCT01219725
- Sponsor's protocol ID
- RG2508/06/08
- Status last verified
- May 2009
- First submitted
- 12 Oct 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Moderate Intensity Exercise Training Programme Improve Cardiac Function and Known Cardiovascular Risk Factors in Middle-aged Women?
- ClinicalTrials.gov ID
- NCT01219725
- Acronym / sponsor ID
- RG2508/06/08
- Conditions
- Cardiovascular Disease
- Keywords
- Body composition, Endothelial function, Lipoprotein profile, Inflammatory markers, Aerobic capacity, Thrombotic markers, Arterial stiffness, Cardiac function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 13 Oct 2010 (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 this study was to examine the effect of 6 months moderate intensity exercise training completed three times per week upon traditional and emerging cardiovascular disease risk factors in postmenopausal women both with and without type 2 diabetes. These risk factors include blood markers associated with increased risk such as cholesterol, insulin, glucose and markers of inflammation plus measures of body fat, heart and lung fitness, vascular stiffness and vascular function. The study hypothesised that moderate intensity exercise training would intervene in the exaggerated risk seen in women following the menopause, especially in those with type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy and stable type II diabetic postmenopausal women (cessation of menstrual periods for 12 months and confirmed with LH/FSH samples) aged 45 - 65 years old for the cross sectional analysis and exercise training study.
Key exclusion criteria (11 listed)
- Identified abnormalities during baseline testing.
- Vigorously active women.
- Women who are pregnant.
- Women with serious systemic or psychological disorders (e.g. COPD, asthma, clinical depression).
- Women with known coronary artery disease.
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 |
|---|---|---|
| Exercise training6 months of moderate intensity exercise training 3 times per week | Behavioural | – |
Primary outcome
Maximal oxygen uptake
Time frame: 6 months
6 secondary outcomes
lipoprotein profile
Time frame: 6 months
Flow mediated dilation
Time frame: 6 months
Cardiac power output
Time frame: 6 months
Arterial stiffness
Time frame: 6 months
Inflammatory markers
Time frame: 6 months
Body composition
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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 Phase 2 study testing Exercise training in people with Cardiovascular Disease, 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 1 inclusion and 11 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 28 Oct 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 11336713, 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: 6 months). 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 28 Oct 2010.