Mechanisms of Disability in Peripheral Arterial Disease
Primary Purpose
Cardiovascular Diseases, Arterial Occlusive Diseases, Peripheral Vascular Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00046592
First Posted
September 30, 2002
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00046592
Brief Title
Mechanisms of Disability in Peripheral Arterial Disease
Study Type
Observational
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine the mechanisms by which atherosclerotic peripheral artery disease (PAD) causes functional impairment and to define the degree to which peripheral artery disease associated pathophysiologic findings change over time.
Detailed Description
BACKGROUND:
Research demonstrates that men and women with lower extremity peripheral arterial disease (PAD) have poorer functioning than men and women without PAD. Preliminary data also indicate that more severe PAD at baseline, as measured by the ankle brachial index (ABI), is associated with a greater incidence of functional loss. However, the pathophysiologic mechanisms in the lower extremities responsible for PAD-related functional impairment and functional loss are not well defined.
DESIGN NARRATIVE:
The study cohort will consist of 790 individuals identified from three Chicago-area medical centers, of whom 500 will have PAD. Participants will undergo a baseline and two annual follow-up visits. Pathophysiologic findings in the lower extremities refer to reduced muscle mass, reduced muscle quality, and reduced peripheral sensory and motor function. Quality of muscle tissue is defined as the ratio of muscle force to muscle mass. Muscle mass will be measured with Computed Tomography (CT). Peripheral nerve function will be determined using surface electroneurography (ENG). Lower extremity functional measures will consist of measures pertinent to functioning during daily living and include six minute walk distance, seven-day physical activity level (assessed by accelerometer), walking speed, balance tests, and lower extremity muscle power.
The cross-sectional study will test the hypotheses that a) chronic lower extremity arterial ischemia is associated with specific pathophysiologic findings in lower extremity muscle and nerve and that b) these ischemia-related pathophysiologic findings are associated with lower extremity functional limitation.The longitudinal study will test the hypotheses that a) greater baseline lower extremity arterial ischemia as measured by ABI is associated with greater progression of pathophysiologic findings over two year follow-up and that b) greater ischemia-related pathophysiologic findings in the legs at baseline is associated with greater functional decline over two year follow up. Results will be used to develop interventions designed to improve lower extremity functioning and prevent functional decline in persons with PAD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Arterial Occlusive Diseases, Peripheral Vascular Diseases
7. Study Design
10. Eligibility
Sex
All
Minimum Age & Unit of Time
59 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary McDermott
Organizational Affiliation
Northwestern University Feinberg School of Medicine
12. IPD Sharing Statement
Learn more about this trial
Mechanisms of Disability in Peripheral Arterial Disease
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