- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00719355
Polestriding Versus Walking for Subjects With Poor Leg Circulation
Polestriding Versus Walking for PAD Rehabilitation
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Illinois
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Hines, Illinois, 미국, 60141
- Edward Hines Jr. VA Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Onset of Claudication Pain During Constant Work Rate Treadmill Test
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Eileen Collins, RN, PhD, University of Illinois at Chicago
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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-
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