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

Purpose

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.

Condition	Intervention
Peripheral Arterial Disease	Behavioral: Supervised exercise Program

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:

Effect of an exercise intervention on walking ability (functional outcome) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Measurement of functional outcome will be done with the following tests:

Walking distance (Six-Minute Walk),Walking speed (Four-Meter Walk),Muscle power and balance (Repeated Chair Rises,Standing Balance Evaluation,Summary Performance Score,Measured daily physical activity.

Enrollment:	368
Study Start Date:	February 2008
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: supervised exercise 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.	Behavioral: Supervised exercise Program 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.
No Intervention: Standard of Care 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.

Arms

Assigned Interventions

Active Comparator: supervised exercise

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.

Behavioral: Supervised exercise Program

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.

No Intervention: Standard of Care

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.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 Toebrachial 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440634

Locations

United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390

Sponsors and Collaborators

American Heart Association

Investigators

Principal Investigator:

Carlos H Timaran, MD

UT Southwestern Medical Center

More Information

No publications provided

Responsible Party:	Carlos H. Timaran, Associate Professor of Surgery, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT01440634 History of Changes
Other Study ID Numbers:	0830128N
Study First Received:	September 22, 2011
Last Updated:	February 11, 2013
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by Dallas VA Medical Center:

Peripheral arterial disease
Community Medicine
Exercise Test
Exercise Therapy

Additional relevant MeSH terms:

Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis

Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013