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Clinical Trials/NCT01219725
NCT01219725
Unknown
Phase 2

Can a Moderate Intensity Exercise Training Programme Improve Cardiac Function and Known Cardiovascular Risk Factors in Middle-aged Women?

University of Leeds1 site in 1 country100 target enrollmentJuly 2005

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
University of Leeds
Enrollment
100
Locations
1
Primary Endpoint
Maximal oxygen uptake
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2005
End Date
December 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Maximal oxygen uptake

Time Frame: 6 months

Secondary Outcomes

  • lipoprotein profile(6 months)
  • Flow mediated dilation(6 months)
  • Cardiac power output(6 months)
  • Arterial stiffness(6 months)
  • Inflammatory markers(6 months)
  • Body composition(6 months)

Study Sites (1)

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