Polestriding Versus Walking for Subjects With Poor Leg Circulation
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Walking with poles
Walking exercise
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Peripheral Vascular Disease
- Cramping/Claudication Pain in legs while walking
- Ankle Brachial Index (measure of circulation by doppler) .90 or less
Exclusion Criteria:
- Ulcers or sores on feet or legs
- Unable to walk or confined to a wheelchair
- Amputations or severe arthritis pain in shoulders, knees, or hips
- Medical conditions which would exclude subject from participating in an exercise program
- Vascular Surgery within the last six months, or planning vascular surgery
Sites / Locations
- Edward Hines Jr. VA Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Walking with Poles
Traditional walking program
Arm Description
Patients were assigned to a 24 week walking with poles program of rehabilitation. The intervention was the additional of poles to the walking program.
Patients were assigned to a 24 week traditional walking program.
Outcomes
Primary Outcome Measures
Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test
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).
Secondary Outcome Measures
Onset of Claudication Pain During Constant Work Rate Treadmill Test
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.
Full Information
NCT ID
NCT00719355
First Posted
July 17, 2008
Last Updated
February 7, 2013
Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00719355
Brief Title
Polestriding Versus Walking for Subjects With Poor Leg Circulation
Official Title
Polestriding Versus Walking for PAD Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effects of polestriding (walking with poles) and traditional walking on physical endurance in subjects with poor circulation in their legs. Another goal is to evaluate the effectiveness of a walking program in increasing the amount of oxygen in the calf muscles and therefore improving overall physical activity and quality of life.
Detailed Description
Peripheral Arterial Disease (PAD/PVD) is caused by decreased blood flow to the legs. The most common symptom is intermittent claudication pain during walking that is relieved by rest. Walking is the primary treatment prescribed for PAD rehabilitation. Polestriding uses muscles of the upper and lower body in a continuous movement. Walking with poles increases stride length, cadence and walking speed and decreases ground reaction forces on the joints. Subjects in this study will participate in a walking program with or without poles.
Dr. Collins' research focuses on physical activity interventions to improve the functional status of persons with chronic illness. Several rehabilitation studies have tested the efficacy of walking exercise for patients with PAD. Studies on polestriding indicate that it may be superior to traditional walking, but these two methods have never been compared. Approximately 30% of patients with coronary artery disease have PAD as their only symptom. As the population ages and more people are affected by this debilitating condition, nurse-initiated rehabilitative therapies, such as polestriding, need to be explored. The consent form explains the purpose of the study in addition to the procedures, risks, benefits, options, confidentiality, costs, and compensation. Participants are also asked to sign a HIPPA authorization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walking with Poles
Arm Type
Experimental
Arm Description
Patients were assigned to a 24 week walking with poles program of rehabilitation. The intervention was the additional of poles to the walking program.
Arm Title
Traditional walking program
Arm Type
Active Comparator
Arm Description
Patients were assigned to a 24 week traditional walking program.
Intervention Type
Behavioral
Intervention Name(s)
Walking with poles
Other Intervention Name(s)
Exercise
Intervention Description
Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise
Other Intervention Name(s)
Exercise
Intervention Description
Patients walked for 20-45 minutes, 3 times/week for 24 weeks.
Primary Outcome Measure Information:
Title
Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test
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
Secondary Outcome Measure Information:
Title
Onset of Claudication Pain During Constant Work Rate Treadmill Test
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Peripheral Vascular Disease
Cramping/Claudication Pain in legs while walking
Ankle Brachial Index (measure of circulation by doppler) .90 or less
Exclusion Criteria:
Ulcers or sores on feet or legs
Unable to walk or confined to a wheelchair
Amputations or severe arthritis pain in shoulders, knees, or hips
Medical conditions which would exclude subject from participating in an exercise program
Vascular Surgery within the last six months, or planning vascular surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen Collins, RN, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15870588
Citation
Collins EG, Langbein WE, Orebaugh C, Bammert C, Hanson K, Reda D, Edwards LC, Littooy FN. Cardiovascular training effect associated with polestriding exercise in patients with peripheral arterial disease. J Cardiovasc Nurs. 2005 May-Jun;20(3):177-85. doi: 10.1097/00005082-200505000-00009.
Results Reference
background
PubMed Identifier
12618567
Citation
Collins EG, Edwin Langbein W, Orebaugh C, Bammert C, Hanson K, Reda D, Edwards LC, Littooy FN. PoleStriding exercise and vitamin E for management of peripheral vascular disease. Med Sci Sports Exerc. 2003 Mar;35(3):384-93. doi: 10.1249/01.MSS.0000053658.82687.FF.
Results Reference
background
PubMed Identifier
12021703
Citation
Langbein WE, Collins EG, Orebaugh C, Maloney C, Williams KJ, Littooy FN, Edwards LC. Increasing exercise tolerance of persons limited by claudication pain using polestriding. J Vasc Surg. 2002 May;35(5):887-93. doi: 10.1067/mva.2002.123756.
Results Reference
background
PubMed Identifier
22495802
Citation
Fritschi C, Collins EG, O'Connell S, McBurney C, Butler J, Edwards L. The effects of smoking status on walking ability and health-related quality of life in patients with peripheral arterial disease. J Cardiovasc Nurs. 2013 Jul-Aug;28(4):380-6. doi: 10.1097/JCN.0b013e31824af587.
Results Reference
result
PubMed Identifier
23050152
Citation
Collins EG, McBurney C, Butler J, Jelinek C, O'Connell S, Fritschi C, Reda D. The Effects of Walking or Walking-with-Poles Training on Tissue Oxygenation in Patients with Peripheral Arterial Disease. Int J Vasc Med. 2012;2012:985025. doi: 10.1155/2012/985025. Epub 2012 Sep 25.
Results Reference
result
PubMed Identifier
22595894
Citation
Collins EG, O'connell S, McBurney C, Jelinek C, Butler J, Reda D, Gerber BS, Hurt C, Grabiner M. Comparison of walking with poles and traditional walking for peripheral arterial disease rehabilitation. J Cardiopulm Rehabil Prev. 2012 Jul-Aug;32(4):210-8. doi: 10.1097/HCR.0b013e31825828f4.
Results Reference
result
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Polestriding Versus Walking for Subjects With Poor Leg Circulation
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