- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00719355
Polestriding Versus Walking for Subjects With Poor Leg Circulation
Polestriding Versus Walking for PAD Rehabilitation
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Illinois
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Hines, Illinois, Forenede Stater, 60141
- Edward Hines Jr. VA Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.
Andre navne:
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Aktiv komparator: Traditional walking program
Patients were assigned to a 24 week traditional walking program.
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Patients walked for 20-45 minutes, 3 times/week for 24 weeks.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test
Tidsramme: Baseline and 24 weeks
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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).
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Baseline and 24 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Onset of Claudication Pain During Constant Work Rate Treadmill Test
Tidsramme: At 24 weeks
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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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At 24 weeks
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Eileen Collins, RN, PhD, University of Illinois at Chicago
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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, 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2004-0477
- R01NR008877 (U.S. NIH-bevilling/kontrakt)
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