NCT01398605

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
Last Updated

August 18, 2011

Status Verified

July 1, 2011

Enrollment Period

1.8 years

First QC Date

July 14, 2011

Last Update Submit

August 16, 2011

Conditions

Postmenopausal Disorder

Keywords

Postmenopausal womenPhysical activityCardiovascular risksCardiac functionDose-response

Outcome Measures

Primary Outcomes (6)

  • Body mass index (BMI)

    3 months

  • Waist circumference

    3 months

  • Lab data (lipid profile, CRP, insulin resistance)

    3 months

  • QT interval and corrected QT interval (QTc)

    3 months

  • Cardiovascular fitness

    3 months

  • Heart rate recovery after exercise test

    3 months

Secondary Outcomes (1)

  • Myocardial perfusion

Study Arms (3)

moderate exercise training

EXPERIMENTAL
Other: Exercise training

intensive exercise training

EXPERIMENTAL
Other: Exercise training

Control

NO INTERVENTION

Interventions

Exercise trainingOTHER

Different dose of exercise training

intensive exercise trainingmoderate exercise training

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known cardiac disease, excessive weight change during last year, cancer and mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ying-Tai Wu, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 20, 2011

Study Start

September 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 18, 2011

Record last verified: 2011-07

Locations

TW(1)