Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women



Sponsors


Source

National Center for Research Resources (NCRR)

Brief Summary

The purpose of this research is to find out whether training at different exercise
intensities reduces the risk of developing cardiovascular disease (CVD) to a different
extent. Heart attacks and stroke are the leading cause of death in older women. Reduced
variability of the heart rate and increased dips and swings in blood pressure are risks
factors that predict the chance of developing CVD as are increased levels of clotting protein
fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol
(>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat
level before you start training and after 15 and 30 weeks of training in the form of walking.
At the present time the effects of exercise intensity on these factors are not well
understood. This study will add to the basic understanding of these issues and allow us to
recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce
the risk of developing CVD.

Overall Status

Completed

Start Date

N/A

Completion Date

N/A

Primary Completion Date

N/A

Phase

N/A

Study Type

Interventional


Conditions


Intervention

Intervention Type

Behavioral

Intervention Name



Eligibility

Criteria

Inclusion Criteria:

- Postmenopausal and preferably on hormone replacement therapy

- In good general health

- Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40

- Exercise less than 20 min/day two days a week

Gender

Female

Minimum Age

50 Years

Maximum Age

65 Years

Healthy Volunteers

Accepts Healthy Volunteers


Location

Facility

3060G Central Campus Recreation Bldg 401 Washtenaw Ave.
Ann Arbor Michigan 48109-2214 United States

Location Countries

Country

United States


Verification Date

2003-12-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Keyword


Has Expanded Access

No

Condition Browse


Secondary Id

M01RR000042

Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Prevention


Study First Submitted

January 18, 2000

Study First Submitted Qc

January 18, 2000

Study First Posted

January 19, 2000

Last Update Submitted

June 23, 2005

Last Update Submitted Qc

June 23, 2005

Last Update Posted

June 24, 2005


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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