Physical Activity in Postmenopausal Women

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01398605
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 3
• Duration (Months): 21.9
• Patients Per Site Per Month: 9.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Postmenopausal Disorder	Other: Exercise training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Physical Activity and Exercise Dose-response on Cardiovascular Risk Factors in Postmenopausal Women
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Body mass index (BMI) [3 months]

2. Waist circumference [3 months]

3. Lab data (lipid profile, CRP, insulin resistance) [3 months]

4. QT interval and corrected QT interval (QTc) [3 months]

5. Cardiovascular fitness [3 months]

6. Heart rate recovery after exercise test [3 months]

Secondary Outcome Measures

1. Myocardial perfusion []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Ying-Tai Wu, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01398605
• Other Study ID Numbers: 200709026R
• First Posted: Jul 20, 2011
• Last Update Posted: Aug 18, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Postmenopausal women; Physical activity; Cardiovascular risks; Cardiac function; Dose-response

Study Results

No Results Posted as of Aug 18, 2011