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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised exercise Program
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, Community Medicine, Exercise Test, Exercise Therapy

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

supervised exercise

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 22, 2011
Last Updated
November 30, 2015
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01440634
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral arterial disease, Community Medicine, Exercise Test, Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supervised exercise
Arm Type
Other
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised exercise Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of an Exercise Intervention on Walking Ability (Functional Outcome)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos H Timaran, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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