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Clinical Trials/NCT01519583
NCT01519583
Completed
Not Applicable

Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore

Pennington Biomedical Research Center1 site in 1 country115 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postmenopausal Disorder
Sponsor
Pennington Biomedical Research Center
Enrollment
115
Locations
1
Primary Endpoint
Resting systolic blood pressure
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
March 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 (self-reported non-exerciser for previous 6 months)
  • 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 greater than 179 mmHg systolic or 99 mmHg diastolic.
  • Participating in another research study which may effect the results of WalkMore

Outcomes

Primary Outcomes

Resting systolic blood pressure

Time Frame: 3 Months

Measured in the seated position using AHA blood pressure measurement guidelines

Secondary Outcomes

  • Resting diastolic blood pressure(3 Months)
  • Accelerometry(3 Months)
  • Brachial Ultrasound(3 Months)
  • Waist Circumference(3 Months)
  • Walking gait(3 Months)

Study Sites (1)

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