Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 22, 2011
February 11, 2014
February 2008
February 2013   (final data collection date for primary outcome measure)
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.
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.

Complete list of historical versions of study NCT01440634 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Arterial Disease
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.
  • 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.
    Intervention: Other: Supervised exercise Program
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
347
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01440634
0830128N
No
Carlos H. Timaran, University of Texas Southwestern Medical Center
American Heart Association
Not Provided
Principal Investigator: Carlos H Timaran, MD UT Southwestern Medical Center
Dallas VA Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP