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
Results First Received: March 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Intervention: Other: Supervised exercise Program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at community centers. Enrollment was performed between february 2008 and June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients that denied to be randomized and/or to follow the schedule for the research procedures was excluded of the study.

Reporting Groups
  Description
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.
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.

Participant Flow for 2 periods

Period 1:   Cross Sectional Phase
    Supervised Exercise     Standard of Care  
STARTED     0     347  
COMPLETED     0     347  
NOT COMPLETED     0     0  

Period 2:   Randomization Phase
    Supervised Exercise     Standard of Care  
STARTED     30     24  
COMPLETED     24     14  
NOT COMPLETED     6     10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Supervised Exercise     Standard of Care     Total  
Number of Participants  
[units: participants]
  24     14     38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     24     14     38  
Age  
[units: years]
Median ( Inter-Quartile Range )
  75  
  ( 68 to 82 )  
  79.5  
  ( 70.5 to 86 )  
  79.5  
  ( 70.5 to 86 )  
Gender  
[units: participants]
     
Female     17     11     28  
Male     7     3     10  
Region of Enrollment  
[units: participants]
     
United States     24     14     38  



  Outcome Measures

1.  Primary:   Effect of an Exercise Intervention on Walking Ability (Functional Outcome)   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was limited by the lack of patients compliance to follow the schedule for the exercise sessions. Patients did not assisted regularly to the walking sessions, and the schedule was completed in 70 % of the plan.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Carlos H Timaran
Organization: UT Southwestern Medical Center
phone: 2146450533
e-mail: timaran1@msn.com


No publications provided


Responsible Party: Carlos H. Timaran, 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