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

The University of Texas System (UT)

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Other: Supervised exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01440634

0830128N

Details and patient eligibility

About

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.

Enrollment: 347 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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347 participants in 2 patient groups

supervised exercise

Other group

Description:

It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. 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.

Treatment:

Other: Supervised exercise Program

Standard of Care

No Intervention group

Description:

Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.