Cardiovascular Prophylaxis for Postmenopausal Women

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01219725
• Other study ID #: RG2508/06/08
• Status: Recruiting
• Phase: Phase 2
• First received: October 12, 2010
• Last updated: October 27, 2010
• Start date: July 2005
• Est. completion date: December 2011

Study information

• Verified date: May 2009
• Source: University of Leeds
• Contact: Karen M Birch, BSc, PhD
• Phone: 44 11336713
• Email: k.m.birch[@]leeds.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Centre for Sports and Exercise Sciences, University of Leeds	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen uptake		6 months	Yes
Secondary	lipoprotein profile		6 months	No
Secondary	Flow mediated dilation		6 months	No
Secondary	Cardiac power output		6 months	No
Secondary	Arterial stiffness		6 months	No
Secondary	Inflammatory markers		6 months	No
Secondary	Body composition		6 months	No