Polestriding Versus Walking for Subjects With Poor Leg Circulation

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Behavioral: Walking with poles; Behavioral: Walking exercise	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	146 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Polestriding Versus Walking for PAD Rehabilitation
Study Start Date :	June 2005
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	May 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Walking with Poles; Patients were assigned to a 24 week walking with poles program of rehabilitation. The intervention was the additional of poles to the walking program.	Behavioral: Walking with poles; Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.; Other Name: Exercise
Active Comparator: Traditional walking program; Patients were assigned to a 24 week traditional walking program.	Behavioral: Walking exercise; Patients walked for 20-45 minutes, 3 times/week for 24 weeks.; Other Name: Exercise

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Illinois
Edward Hines Jr. VA Hospital
Hines, Illinois, United States, 60141

Sponsors and Collaborators

University of Illinois at Chicago

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:	Eileen Collins, RN, PhD	University of Illinois at Chicago

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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.

Collins EG, Oʼconnell 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.

Other Publications:

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.

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.

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.

Responsible Party:	Eileen G. Collins, Professor, University of Illinois
ClinicalTrials.gov Identifier:	NCT00719355 History of Changes
Other Study ID Numbers:	2004-0477; R01NR008877 ( U.S. NIH Grant/Contract )
First Posted:	July 21, 2008
Results First Posted:	September 28, 2012
Last Update Posted:	February 12, 2013
Last Verified:	February 2013

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis	Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases