Ankle-foot Orthoses for Peripheral Artery Disease
2019년 7월 9일 업데이트: University of Minnesota
Efficacy of Ankle-Foot Orthoses on Walking Ability in Peripheral Artery Disease: The AFO for PAD Trial I
The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).
연구 개요
상세 설명
The investigators will test the hypothesis that PAD patients using an AFO during a graded exercise test will demonstrate a greater PWT compared to PWT assessed without the use of an AFO.
Secondary hypotheses include evaluation of the effect of an AFO on: 1) calf muscle function, 2) claudication onset time, 3) functional ability, 4) peak oxygen consumption, and 5) patient-reported outcomes.
We will also examine the effects of the AFO on outcomes following 12 weeks of community walking.
연구 유형
중재적
등록 (실제)
31
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Montana
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Missoula, Montana, 미국, 59802
- International Heart Institute of Montana Foundation
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Men and women diagnosed with atherosclerotic peripheral arterial disease (PAD).
- Patients who experience calf claudication
- ≥40 years of age
- An abnormal ankle-brachial index (ABI) of ≤.90.
- For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI
Exclusion Criteria:
- Lower extremity amputation(s) which interfere(s) with walking.
- Critical limb ischemia (i.e., ischemic rest pain, ulcers/gangrene on the lower extremities).
- Non-atherosclerotic PAD (e.g., popliteal entrapment syndrome, Takayasu's arteritis)
- Major surgical procedures that are contraindicated to an exercise program (e.g., recent organ transplant) or coronary artery bypass graft within 6 months prior to screening.
- Primarily limitations to exercise due to chronic obstructive pulmonary disease, angina or heart failure.
- Myocardial infarction within 3 months prior to screening.
- Acute coronary syndrome symptoms diagnosed at time of screening.
- Significant ischemic changes (documented on the 12-lead electrocardiogram) with horizontal or down-sloping ST-segment depression ≥ 0.5mm at rest and >1 mm with exercise in 3 beats for 2 contiguous leads, relative to the PR-segment (or ST-segment elevation ≥1mm).
- Transient ischemic attack or stroke 3 months prior to screening.
- New left bundle branch block or sustained ventricular tachycardia >30 seconds during screening.
- Uncontrolled hypertension defined as ≥180 systolic or ≥100 diastolic resting blood pressure during screening.
- Women who are pregnant (women of childbearing potential, a pregnancy test will be performed at screening.
- Individuals currently incarcerated.
- Evidence of acute impairment from alcohol or other illicit drugs.
- Lack of diabetes control (glycated hemoglobin >12%)
- Patients who are anemic (Hgb <11 g/dL for women and <10 g/dL for men).
- Any other clinically significant diseases (e.g., pulmonary, renal, psychiatric, immunological) that are not stabilized or may otherwise confound the results of the study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: AFO to improve outcomes
Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum
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Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation.
The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.
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간섭 없음: Historical Controls
Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in WIQ Distance Subscore
기간: 12 weeks
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In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty.
The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs.
The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
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12 weeks
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Change in WIQ Speed Subscore
기간: 12 weeks
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In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty.
The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs.
The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
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12 weeks
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Change in WIQ Stair-Climbing Subscore
기간: 12 weeks
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In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty.
The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs.
The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
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12 weeks
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Change in SF-36 PCS
기간: 12 weeks
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Change in Medical Outcomes Study Short Form 36-item questionnaire, Physical Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health).
These subscores are weighted sums of the questions in each section.
Scores range from 0 - 100.
Lower scores = more disability, higher scores = less disability.
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12 weeks
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Change in SF-36 MCS
기간: 12 weeks
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Change in Medical Outcomes Study Short Form 36-item questionnaire, Mental Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health).
These subscores are weighted sums of the questions in each section.
Scores range from 0 - 100.
Lower scores = more disability, higher scores = less disability.
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12 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ryan J. Mays, PhD, MPH, MS, International Heart Institute of Montana Foundation
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 11월 1일
기본 완료 (실제)
2017년 12월 1일
연구 완료 (실제)
2017년 12월 1일
연구 등록 날짜
최초 제출
2014년 10월 28일
QC 기준을 충족하는 최초 제출
2014년 10월 28일
처음 게시됨 (추정)
2014년 10월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 7월 9일
마지막으로 확인됨
2019년 7월 1일
추가 정보
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