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Cardiovascular Prophylaxis for Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Leeds.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Leeds
ClinicalTrials.gov Identifier:
NCT01219725
First received: October 12, 2010
Last updated: October 27, 2010
Last verified: May 2009
History of Changes
  Purpose

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 Intervention Phase
Cardiovascular Disease
 Behavioral: Exercise training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Maximal oxygen uptake [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • lipoprotein profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Flow mediated dilation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cardiac power output [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Arterial stiffness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2005
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Exercise training
    6 months of moderate intensity exercise training 3 times per week
  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr Karen Michelle Birch, University of Leeds
ClinicalTrials.gov Identifier: NCT01219725     History of Changes
Other Study ID Numbers: RG2508/06/08
Study First Received: October 12, 2010
Last Updated: October 27, 2010
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on June 18, 2013