Peripheral Arterial Disease Clinical Trial
Official title:
Polestriding Versus Walking for PAD Rehabilitation
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Edward Hines Jr. VA Hospital | Hines | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Institute of Nursing Research (NINR) |
United States,
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
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 |
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