View Clinical Trial (Medical Research Study)
Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore
| City: |
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Baton Rouge |
| State: |
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Louisiana |
| Zip Code: |
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70808 |
| Conditions: |
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Postmenopausal Disorder - Blood Pressure - Over Weight |
| Purpose: |
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The WalkMore study will help find out how walking interventions can help overweight/obese
postmenopausal women with increased risk of cardiovascular disease lower their blood
pressure.
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| Study Summary: |
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Baseline assessment, then a three month intervention or control condition, followed by
another assessment at the end of the study. Participants will be screened for blood
pressure, height, weight, and the distance around the waist. Participants who meet the
eligibility criteria will be given a pedometer to log steps for one week. During visit 2,
participants will return the pedometer, and are able to self-monitor appropriately, they
will be given an accelerometer to wear for one week.
Pedometry:
Participants will wear a small device which will measure the amount of steps accumulated for
7 days during the first week of the run-in period and again at follow-up (Control group will
not perform follow-up pedometry).
Accelerometry:
Participants will be asked to wear a small device similar to a pedometer attached to a belt
at the hip to measure physical activity levels for 7 days during the second week of the
run-in period and again at the week prior to follow-up.
Assessment Visits (Baseline and 3 Months):
Blood pressure, fitness, brachial ultrasound (measure of the health of the artery), height,
body weight, and waist measurement will be measured at the beginning of the main study and
again after the 3-month period.
Maximal Exertion Treadmill Test:
Aerobic fitness level will be assessed while the participant walks or runs on a treadmill.
The amount of energy expended during the test will increase at regular increments. The
warm-up period will last for 5 minutes and then the exercise will get progressively harder
due to increases in speed and/or grade until the participant is too tired to continue.
Fatigue in most cases will be due to the muscles becoming too tired to perform the work
required at each stage. The volume of oxygen intake and carbon dioxide (CO2) production will
be measured continuously using a non-invasive instrument known as a metabolic cart. The test
requires that the participant breathe through a mouthpiece - similar to a snorkel - with a
nose clip on. That mouthpiece is attached to a long tube, which is then attached to the
metabolic cart. Heart rate will also be monitored continuously using a 12 lead ECG.
Brachial Artery Ultrasound:
An ultrasound is a procedure that uses sound waves to create a picture. The brachial artery
ultrasound measures how elastic the arteries are and the thickness of the lining of the
major blood vessel in the upper arm (the brachial artery). After resting for fifteen
minutes, an ultrasound probe will be placed over the brachial artery in the elbow area on
the non-dominant arm. A blood pressure cuff will be inflated around the forearm for five
minutes to reduce blood flow. When the cuff is deflated, the ultrasound will be continued
for five more minutes to observe the blood flowing back into the arm.
Walking Gait:
Participants will walk across a 16 foot computerized floor mat, which will measure walking
speed. After a couple practice walks, the participant will be asked to walk 2 times across
the mat at 6 different self-selected paces: very slow, slow, preferred/normal, fast, very
fast, and as quickly as possible (without running). The participant will be able to rest as
needed. The computerized mat will measure walking speed and other elements associated with
the pace at which the participant walks.
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| Criteria: |
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Inclusion Criteria:
- Woman between 45-74 years of age
- Have not had a menstrual period for at least 12 months
- Are not regularly physically active
- Have a body mass index (BMI) between 25-45 kg/m2
- Have high normal blood pressure or (systolic pressure of 130-179 mmHg or a diastolic
pressure of 85-99 mmHg)
- Not limited in your ability to walk
- Understand these criteria
- Are willing to provide informed consent
- Willing to be randomized to either type of walking intervention or a control group
being studied, and are willing to follow the protocol for the group to which they
have been assigned
Exclusion Criteria:
- Have a past history and/or physical examination or laboratory findings of a medical
condition including (but not limited to):
- Have any medical condition or disease that is life-threatening or that can interfere
with or be aggravated by exercise
- Have been diagnosed with diabetes
- Blood pressure is less than 130 mmHg systolic or 85 mmHg diastolic.
- Blood pressure is greater than 179 mmHg systolic or 99 mmHg diastolic.
- Participating in another research study which may effect the results of WalkMore
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| NCT ID: |
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NCT01519583 |
| Primary Contact: |
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Principal Investigator
Catrine Tudor-Locke, PhD
Pennington Biomedical Research Center
Catrine E Tudor-Locke, Ph.D.
Phone: 225-763-2974
Email: Catrine.Tudor-Locke@pbrc.edu
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| Backup Contact: |
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Email: Damon.Swift@pbrc.edu
Damon L Swift, Ph.D.
Phone: 225-763-2917
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| Location Contact: |
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Baton Rouge, Louisiana 70808
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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