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Clinical Trials/NCT01440634
NCT01440634
Completed
Not Applicable

Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.

University of Texas Southwestern Medical Center1 site in 1 country347 target enrollmentFebruary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
University of Texas Southwestern Medical Center
Enrollment
347
Locations
1
Primary Endpoint
Effect of an Exercise Intervention on Walking Ability (Functional Outcome)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results from progressive atherosclerosis of arteries in the lower extremities. PAD is also associated with major detrimental effects on quality of life and functional status, and is the most important cause of limb amputation. More importantly, PAD is a major manifestation of cardiovascular disease and a potent predictor of myocardial infarction, stroke and death. Despite its frequent occurrence, little is known about the natural history of PAD in Hispanics who represent 12.5% of the United States. Because access to health care is limited among Hispanics, CBPR is the ideal process to reach this target population. The goal of the proposed study is to evaluate community-based strategies of detection and treatment of peripheral arterial disease (PAD) in Hispanics. The proposed project consists of two phases: a cross-sectional phase (PAD detection), followed by a randomization phase.During the PAD detection study , the prevalence and severity of PAD in this population will be determined. Specific risk factors associated with PAD among the Hispanic participants will be identified. During the second phase patients will be enrolled in a randomized, non-blinded trial comparing a community-based risk factor modification and supervised exercise program versus usual care for PAD. These individuals will undergo a baseline evaluation similar to the one obtained during the first phase of the study, but will also include functional testing of the lower extremities.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
February 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carlos H Timaran

Associate Professor of Surgery

University of Texas Southwestern Medical Center

Eligibility Criteria

Inclusion Criteria

  • Cross-Sectional phase:
  • Hispanic men and women aged 70 years or older.
  • Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
  • Individual has been informed of the nature, procedures and risks of the study, and has signed a consent form approved by UT Southwestern Institutional Review Board.
  • Randomization phase:
  • Hispanic men and women aged 70 years or older
  • English or Spanish speaking
  • Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
  • Documented peripheral arterial disease with an Ankle-brachial index (ABI) \< 0.9 or Toe-brachial index (TBI) \<0.7, and abnormal Pulse Volume Recordings (PVR).
  • Ability to ambulate independently.

Exclusion Criteria

  • Cross-Sectional Phase
  • Individuals with severe dementia.
  • Individuals with inability to provide informed consent.
  • Bilateral lower or upper extremities amputations.
  • Pregnancy or lactation. Randomization Phase
  • Non-ambulatory
  • Individuals with prior below- or above-knee amputations
  • Individuals unable to give informed consent
  • Individuals unwilling to perform the functional tests or quality of life assessments
  • Individuals unable to perform exercise therapy, functional tests or quality of life assessments due to severe comorbidities

Outcomes

Primary Outcomes

Effect of an Exercise Intervention on Walking Ability (Functional Outcome)

Time Frame: 6 months

Walking distance (Six-Minute Walk test). Following a standardized protocol, individuals are instructed to walk back and forth a 100-ft hallway as far as they can in six minutes after instructions to cover as much distance as possible. A research assistant walks slightly behind each participant so as not to pace the individual. The research assistant records whether or not each person stops during the 6-minute walk. During the proposed study, members of the research team and trained lay health promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals. Data will be reported on meters walked.

Study Sites (1)

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