Cardiovascular Prophylaxis for Postmenopausal Women

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Exercise training

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Karen M Birch, BSc, PhD; Phone Number: 44 11336713; Email: k.m.birch@leeds.ac.uk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal oxygen uptake	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Leeds
• Investigators: Principal Investigator: Karen M Birch, BSC, PhD, University of Leeds

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2010
• Last Update Submitted That Met QC Criteria: October 27, 2010
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Body composition; Endothelial function; Arterial stiffness; Inflammatory markers; Aerobic capacity; Cardiac function; Traditional and emerging cardiovascular disease risk factors; Lipoprotein profile; Thrombotic markers
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: RG2508/06/08