Polestriding Versus Walking for Subjects With Poor Leg Circulation

Peripheral Arterial Disease Clinical Trial

Official title:

Polestriding Versus Walking for PAD Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719355
• Other study ID #: 2004-0477
• Secondary ID: R01NR008877
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2008
• Last updated: February 7, 2013
• Start date: June 2005
• Est. completion date: May 2011

Study information

• Verified date: February 2013
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Walking with poles
Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.
• Walking exercise
Patients walked for 20-45 minutes, 3 times/week for 24 weeks.

Locations

Country	Name	City	State
United States	Edward Hines Jr. VA Hospital	Hines	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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: 10.1155/2012/985 — View 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. — View 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: 10.10 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 24 weeks	No
Secondary	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.	At 24 weeks	No