NCT01219725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 28, 2010

Status Verified

May 1, 2009

Enrollment Period

6.4 years

First QC Date

October 12, 2010

Last Update Submit

October 27, 2010

Conditions

Cardiovascular Disease

Keywords

Body compositionEndothelial functionLipoprotein profileInflammatory markersAerobic capacityThrombotic markersArterial stiffnessCardiac functionTraditional and emerging cardiovascular disease risk factors

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake

    6 months

Secondary Outcomes (6)

  • lipoprotein profile

    6 months

  • Flow mediated dilation

    6 months

  • Cardiac power output

    6 months

  • Arterial stiffness

    6 months

  • Inflammatory markers

    6 months

  • +1 more secondary outcomes

Interventions

Exercise trainingBEHAVIORAL

6 months of moderate intensity exercise training 3 times per week

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Sports and Exercise Sciences, University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karen M Birch, BSC, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen M Birch, BSc, PhD

CONTACT

44 11336713k.m.birch@leeds.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

July 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 28, 2010

Record last verified: 2009-05

Locations

GB(1)