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Physical Activity in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01398605
First received: July 14, 2011
Last updated: August 16, 2011
Last verified: July 2011
History of Changes
  Purpose

The study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function.


Condition Intervention
Postmenopausal Disorder
 Other: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Physical Activity and Exercise Dose-response on Cardiovascular Risk Factors in Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Body mass index (BMI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Lab data (lipid profile, CRP, insulin resistance) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • QT interval and corrected QT interval (QTc) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cardiovascular fitness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Heart rate recovery after exercise test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial perfusion [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: moderate exercise training Other: Exercise training
Different dose of exercise training
Experimental: intensive exercise training Other: Exercise training
Different dose of exercise training
No Intervention: Control

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women aged 40 to 80 years and age matched men without major diseases

Exclusion Criteria:

  • Known cardiac disease, excessive weight change during last year, cancer and mental disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398605

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ying-Tai Wu, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Ying-Tai Wu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
ClinicalTrials.gov Identifier: NCT01398605     History of Changes
Other Study ID Numbers: 200709026R
Study First Received: July 14, 2011
Last Updated: August 16, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Postmenopausal women
Physical activity
Cardiovascular risks
Cardiac function
Dose-response

ClinicalTrials.gov processed this record on May 22, 2013