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Cardiovascular Prophylaxis for Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01219725
Recruitment Status : Unknown
Verified May 2009 by University of Leeds.
Recruitment status was:  Recruiting
First Posted : October 13, 2010
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
University of Leeds

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: Exercise training Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can a Moderate Intensity Exercise Training Programme Improve Cardiac Function and Known Cardiovascular Risk Factors in Middle-aged Women?
Study Start Date : July 2005
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Behavioral: Exercise training
    6 months of moderate intensity exercise training 3 times per week


Primary Outcome Measures :
  1. Maximal oxygen uptake [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. lipoprotein profile [ Time Frame: 6 months ]
  2. Flow mediated dilation [ Time Frame: 6 months ]
  3. Cardiac power output [ Time Frame: 6 months ]
  4. Arterial stiffness [ Time Frame: 6 months ]
  5. Inflammatory markers [ Time Frame: 6 months ]
  6. Body composition [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219725


Contacts
Contact: Karen M Birch, BSc, PhD 44 11336713 k.m.birch@leeds.ac.uk

Locations
United Kingdom
Centre for Sports and Exercise Sciences, University of Leeds Recruiting
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Principal Investigator: Karen M Birch, BSc, PhD         
Sponsors and Collaborators
University of Leeds
Investigators
Principal Investigator: Karen M Birch, BSC, PhD University of Leeds

Responsible Party: Dr Karen Michelle Birch, University of Leeds
ClinicalTrials.gov Identifier: NCT01219725     History of Changes
Other Study ID Numbers: RG2508/06/08
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: May 2009

Keywords provided by University of Leeds:
Body composition
Endothelial function
Lipoprotein profile
Inflammatory markers
Aerobic capacity
Thrombotic markers
Arterial stiffness
Cardiac function
Traditional and emerging cardiovascular disease risk factors

Additional relevant MeSH terms:
Cardiovascular Diseases