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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
No prior amputations other than toe or partial foot amputations that do not impede walking.
Patient has been informed of the nature, procedures and risks of the study, and has signed a consent form approved by the UT Southwestern Institutional Review Board.

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
Presence of concurrent illness with an anticipated life expectancy less than six months
Individuals with planned operative interventions

Treatment and study plan

Supervised exercise program

Other

Supervised exercise Program consist of six months of supervised, intermittent track walking. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month. During each exercise session, individuals will be encouraged to walk at a speed of approximately 2 mph until they achieve leg pain or discomfort on walking of moderate severity.Individuals are then allowed to have a brief period of standing or sitting rest to permit symptoms to resolve before they resume exercise.

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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Sep 26, 2011
Registry last updated: Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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