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临床试验/NCT01440634
NCT01440634已完成不适用

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

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
347
试验地点
2
主要终点
Effect of an Exercise Intervention on Walking Ability (Functional Outcome)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Effect of an Exercise Intervention on Walking Ability (Functional Outcome)

时间窗: 6 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos H Timaran

Associate Professor of Surgery

University of Texas Southwestern Medical Center

研究点 (2)

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