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Polestriding Versus Walking for Subjects With Poor Leg Circulation

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Eileen G. Collins, University of Illinois
ClinicalTrials.gov Identifier:
NCT00719355
First received: July 17, 2008
Last updated: February 7, 2013
Last verified: February 2013
Results First Received: May 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Interventions: Behavioral: Walking with poles
Behavioral: Walking exercise

  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 University of Illinois at Chicago, the Edward Hines Jr., VA Hospital, through radio and print advertising. 146 patients were enrolled in the study and 103 were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened prior to randomization. Patients were disqualified from the study due to coronary arterial disease, they changed their mind, other medical reasons or it was found that they did not have periphaeral arterial disease.

Reporting Groups
  Description
Walking With Poles Patients exercised using walking poles, 3 times weekly for 24 weeks.
Traditional Walking Group Patients exercised for 24 weeks as part of a traditional walking training group.

Participant Flow:   Overall Study
    Walking With Poles   Traditional Walking Group
STARTED   51   52 
Completed 6 Weeks   49   48 
Completed 12 Weeks   43   46 
Completed 24 Weeks   34   43 
Completed 32 Weeks   33   39 
COMPLETED   33   39 
NOT COMPLETED   18   13 
Death                0                1 
Medical                14                5 
Compliance                4                6 
Moved                0                1 



  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
Walking With Poles Patients exercised using walking poles, 3 times weekly for 24 weeks.
Traditional Walking Group Patients exercised for 24 weeks as part of a traditional walking training group.
Total Total of all reporting groups

Baseline Measures
   Walking With Poles   Traditional Walking Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   52   103 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   17   22   39 
>=65 years   34   30   64 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.4  (9.1)   68.0  (8.5)   69.7  (8.9) 
Gender 
[Units: Participants]
     
Female   4   3   7 
Male   47   49   96 
Region of Enrollment 
[Units: Participants]
     
United States   51   52   103 


  Outcome Measures
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1.  Primary:   Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test   [ Time Frame: Baseline and 24 weeks ]

2.  Secondary:   Onset of Claudication Pain During Constant Work Rate Treadmill Test   [ Time Frame: At 24 weeks ]


  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
Due to the small number of women in the trial, results cannot be generalized to women.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Eileen G. Collins PhD, RN
Organization: University of Illinois at Chicago
phone: 312-413-5621
e-mail: ecollins@uic.edu


Publications of Results:
Other Publications:

Responsible Party: Eileen G. Collins, University of Illinois
ClinicalTrials.gov Identifier: NCT00719355     History of Changes
Other Study ID Numbers: 2004-0477
R01NR008877 ( US NIH Grant/Contract Award Number )
Study First Received: July 17, 2008
Results First Received: May 15, 2012
Last Updated: February 7, 2013
Health Authority: United States: Federal Government