- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398605
Physical Activity in Postmenopausal Women
August 16, 2011 updated by: National Taiwan University Hospital
Physical Activity and Exercise Dose-response on Cardiovascular Risk Factors in Postmenopausal Women
The study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: moderate exercise training
|
Different dose of exercise training
|
|
Experimental: intensive exercise training
|
Different dose of exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body mass index (BMI)
Time Frame: 3 months
|
3 months
|
|
Waist circumference
Time Frame: 3 months
|
3 months
|
|
Lab data (lipid profile, CRP, insulin resistance)
Time Frame: 3 months
|
3 months
|
|
QT interval and corrected QT interval (QTc)
Time Frame: 3 months
|
3 months
|
|
Cardiovascular fitness
Time Frame: 3 months
|
3 months
|
|
Heart rate recovery after exercise test
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Myocardial perfusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ying-Tai Wu, phD, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
July 14, 2011
First Submitted That Met QC Criteria
July 19, 2011
First Posted (Estimate)
July 20, 2011
Study Record Updates
Last Update Posted (Estimate)
August 18, 2011
Last Update Submitted That Met QC Criteria
August 16, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 200709026R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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