Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
|ClinicalTrials.gov Identifier: NCT01440634|
Recruitment Status : Completed
First Posted : September 26, 2011
Results First Posted : March 28, 2014
Last Update Posted : December 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Other: Supervised exercise Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||347 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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.
- Effect of an Exercise Intervention on Walking Ability (Functional Outcome) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440634
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Carlos H Timaran, MD||UT Southwestern Medical Center|