Polestriding Versus Walking for Subjects With Poor Leg Circulation
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| ClinicalTrials.gov Identifier: NCT00719355 |
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Recruitment Status :
Completed
First Posted : July 21, 2008
Results First Posted : September 28, 2012
Last Update Posted : February 12, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peripheral Arterial Disease | Behavioral: Walking with poles Behavioral: Walking exercise | Phase 2 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Walking with poles
Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.
Other Name: Exercise |
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Active Comparator: Traditional walking program
Patients were assigned to a 24 week traditional walking program.
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Behavioral: Walking exercise
Patients walked for 20-45 minutes, 3 times/week for 24 weeks.
Other Name: Exercise |
- 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).
- 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.
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719355
| United States, Illinois | |
| Edward Hines Jr. VA Hospital | |
| Hines, Illinois, United States, 60141 | |
| Principal Investigator: | Eileen Collins, RN, PhD | University of Illinois at Chicago |
Other Publications:
| Responsible Party: | Eileen G. Collins, Professor, University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT00719355 |
| Other Study ID Numbers: |
2004-0477 R01NR008877 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 21, 2008 Key Record Dates |
| Results First Posted: | September 28, 2012 |
| Last Update Posted: | February 12, 2013 |
| Last Verified: | February 2013 |
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Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |