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

NCT ID: NCT01440634

Last Updated: 2015-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-02-28

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease; Community Medicine; Exercise Test; Exercise Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Supervised exercise Program

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Carlos H Timaran

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos H Timaran, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

0830128N

Identifier Type: -

Identifier Source: org_study_id