Clinical trial NCT01440634: Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
Official title: Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral arterial disease
Community Medicine
Exercise Test
Exercise Therapy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 347
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.
* 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

Primary outcomes:
measure: Effect of an Exercise Intervention on Walking Ability (Functional Outcome)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Carlos H Timaran, MD
role: PRINCIPAL_INVESTIGATOR
References: