Physical Activity and Metabolic Risk Factors in Postmenop... | NCT01259661

Studies
Physical Activity and Metabolic Risk Factors in Postmenopausal Women

NCT01259661

Sponsor

Taipei Medical University WanFang Hospital

Status

Unknown status

Last Update Posted

Dec 14, 2010Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Postmenopausal Women

Interventions

A longitudinal intervention

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2011Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Dec 7, 2010

First Submission Date that Met QC Criteria

Dec 12, 2010

First Posted Date

Dec 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2010

Last Update Posted Date

Dec 14, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Taipei Medical University WanFang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. Women exhibiting "the metabolic syndrome" have multiple coronary artery disease risk factors, including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted to test the hypotheses: (1) physical activity and physical fitness levels may have effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance exercise training may have a favorable effect on components of the metabolic risk variables in these women.

In this study, the associations among physical activity (including daily energy expenditure and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level, and metabolic risk profile of the women will be assessed. The investigators will perform a randomized trial to compare the effects of moderate-intensity aerobic exercise training regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study. Differences from baseline to follow-up will be calculated and compared across groups.

Results of this study may help health care providers providing advice to postmenopausal women for life style changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group	Experimental		Other: A longitudinal intervention
Control Group	Active Comparator		Other: A longitudinal intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A longitudinal intervention	Other	In our longitudinal intervention study, all eligible subjects will undergo a physical examination by a physician to rule out obvious secondary causes of hypertension and contraindications to exercise. Randomization will be performed by random member generation. The exercise participants will attend three sessions per week at the facility during the study period. Training intensity is initially set at heart rate equivalent to 60% and progress to 80% of each subject's maximal heart rate reserve for 30 min/day with a frequency of 3 days/wk. Facility-based exercise sessions will consist of treadmill walking.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postmenopausal women's daily energy expenditure		12 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have one or more metabolic risk variables as defined by the ATP III (2001)
age between 35 and 64 years
absence of known heart disease
resting BP: 130 < SBP < 160 and 85 < DBP < 100
currently physical inactive (< 30 min of physical activity per week)

Exclusion Criteria:

None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jen-Chen Tsai	Contact	886-2-27361661	6308	jenchent@tmu.edu.tw

Overall Officials

Name	Affiliation	Role
Jen-Chen Tsai	Taipei Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University WanFang Hospital	Recruiting	Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D001519	Behavior
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided