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Polestriding Versus Walking for Subjects With Poor Leg Circulation

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ClinicalTrials.gov Identifier: NCT00719355
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : September 28, 2012
Last Update Posted : February 12, 2013
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Eileen G. Collins, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Peripheral Arterial Disease
Interventions Behavioral: Walking with poles
Behavioral: Walking exercise
Enrollment 146
Recruitment Details 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 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.
Arm/Group Title Walking With Poles Traditional Walking Group
Hide Arm/Group Description Patients exercised using walking poles, 3 times weekly for 24 weeks. Patients exercised for 24 weeks as part of a traditional walking training group.
Period Title: Overall Study
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
Reason Not Completed
Death             0             1
Medical             14             5
Compliance             4             6
Moved             0             1
Arm/Group Title Walking With Poles Traditional Walking Group Total
Hide Arm/Group Description Patients exercised using walking poles, 3 times weekly for 24 weeks. Patients exercised for 24 weeks as part of a traditional walking training group. Total of all reporting groups
Overall Number of Baseline Participants 51 52 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  33.3%
22
  42.3%
39
  37.9%
>=65 years
34
  66.7%
30
  57.7%
64
  62.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 52 participants 103 participants
71.4  (9.1) 68.0  (8.5) 69.7  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
Female
4
   7.8%
3
   5.8%
7
   6.8%
Male
47
  92.2%
49
  94.2%
96
  93.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 52 participants 103 participants
51 52 103
1.Primary Outcome
Title Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test
Hide Description Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed on patients with at least 1 follow-up treadmill test from baseline.
Arm/Group Title Walking With Poles Traditional Walking Group
Hide Arm/Group Description:
Patients exercised using walking poles, 3 times weekly for 24 weeks.
Patients exercised for 24 weeks as part of a traditional walking training group.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: minutes
15.15  (12.31) 21.40  (16.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Walking With Poles, Traditional Walking Group
Comments Observed power for our primary analysis was 0.64.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments A priori level of significance was set at p <0.05.
Method ANCOVA
Comments Repeated-measures ANCOVA using intent-to-treat procedures, was used for the primary outcome variable. Analyses were adjusted for age.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.25
Parameter Dispersion
Type: Standard Deviation
Value: 14.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Onset of Claudication Pain During Constant Work Rate Treadmill Test
Hide Description Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded.
Time Frame At 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test.
Arm/Group Title Walking With Poles Traditional Walking Group
Hide Arm/Group Description:
Patients exercised using walking poles, 3 times weekly for 24 weeks.
Patients exercised for 24 weeks as part of a traditional walking training group.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: minutes
9.3  (12.1) 6.8  (4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Walking With Poles, Traditional Walking Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments [Not Specified]
Method ANCOVA
Comments Repeated measures ANCOVA was used with intent to treat analysis. The co-variant was age.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Parameter Dispersion
Type: Standard Deviation
Value: 3.65
Estimation Comments [Not Specified]
Time Frame Adverse events were collected for 32 weeks (the duration of the study).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Walking With Poles Traditional Walking Group
Hide Arm/Group Description Patients exercised using walking poles, 3 times weekly for 24 weeks. Patients exercised for 24 weeks as part of a traditional walking training group.
All-Cause Mortality
Walking With Poles Traditional Walking Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Walking With Poles Traditional Walking Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/51 (7.84%)      6/52 (11.54%)    
Cardiac disorders     
Hospitalization cardiac related *  3/51 (5.88%)  3 1/52 (1.92%)  1
Endocrine disorders     
Hospitalization low blood sugar *  0/51 (0.00%)  0 1/52 (1.92%)  1
Gastrointestinal disorders     
Hospitalization bowel obstruction *  0/51 (0.00%)  0 1/52 (1.92%)  1
Renal and urinary disorders     
Hospitalization renal disease * [1]  0/51 (0.00%)  0 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders     
Hospitalization respiratory * [2]  2/51 (3.92%)  2 1/52 (1.92%)  1
Vascular disorders     
Death   0/51 (0.00%)  0 1/52 (1.92%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Patient hospitalized for acute renal failure.
[2]
Includes hospitalizations for pnemonia and upper respiratory tract infections.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Walking With Poles Traditional Walking Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/52 (3.85%)      3/51 (5.88%)    
Social circumstances     
Fall   2/52 (3.85%)  2 3/51 (5.88%)  3
Indicates events were collected by systematic assessment
Due to the small number of women in the trial, results cannot be generalized to women.
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
Responsible Party: Eileen G. Collins, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00719355     History of Changes
Other Study ID Numbers: 2004-0477
R01NR008877 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2008
First Posted: July 21, 2008
Results First Submitted: May 15, 2012
Results First Posted: September 28, 2012
Last Update Posted: February 12, 2013