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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos H. Timaran, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01440634
First received: September 22, 2011
Last updated: February 11, 2014
Last verified: February 2014
  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
Other: 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:


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 ]
    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.


Enrollment: 347
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
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.
Other: 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 8, 2013
Last Updated: February 11, 2014
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 July 23, 2014