Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01519583 |
Other study ID # |
PBRC 11018 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2012 |
Est. completion date |
March 2016 |
Study information
Verified date |
September 2022 |
Source |
Pennington Biomedical Research Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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, brachial ultrasound (measure of the health of the artery), blood draw
(fasting blood glucose and insulin), height, body weight, and waist measurement will be
measured at the beginning of the main study and again after the 3-month period.
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.
Blood Draw:
A fasting blood draw will occur to obtain fasting glucose and insulin.
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.