Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
2014년 11월 19일 업데이트: University of Florida
Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
90
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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Florida
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Gainesville, Florida, 미국, 32607
- UF&Shands Orthopaedics and Sports Medicine Institute
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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
60년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Osteoarthritis (OA) of the knee for >6 months
- moderate to severe pain immediately following a 50-foot walk
- knee pain primarily due to tibiofemoral OA and not from patellofemoral OA
- bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee
- willing and able to participate in regular exercise for four months
- free from musculoskeletal limitations that would preclude resistance exercise participation
- free of abnormal cardiovascular responses during the screening graded maximal walk test
Exclusion Criteria:
- unable to walk
- regular resistance exercise training (>3X week) within the past 6 months
- specific low back pain or acute back injury
- spinal stenosis that precludes walking one block due to neurogenic claudication
- any major injury to either knee within the prior 12 months
- any surgery to either knee within the last 12 months
- lumbar radiculopathy
- vascular claudication
- significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee
- have had corticosteroid or viscosupplement injections within three months of study participation
- have added new over the counter or prescription pain medication within two months of study participation
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Wait-list Non-exercise Control (CON)
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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Subjects will continue to participate in their normal activities and clinical care during the four month study.
Telephone contact will be made weekly to encourage adherence to the knee management guidelines
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활성 비교기: Concentric Focused RX (CRX)
Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
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Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
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활성 비교기: Eccentric Focused RX (ERX)
The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while "assistance" is provided by the machine during the concentric phase.
One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
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Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
기간: Baseline, 4 Months
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The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status. Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible). 0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst) |
Baseline, 4 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Six Minute Walk Test; Change From Baseline at 4 Months
기간: Baseline, 4 Months
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Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes.
Subjects will complete the walk test at the time intervals indicated to document any change.
6 minute walk test is a baseline and 4 month post intervention measurement.
It is used to measure distance covered while walking during 6 minutes.
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Baseline, 4 Months
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Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
기간: Baseline, 4 Months
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Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time.
Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.
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Baseline, 4 Months
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Leg Press Test; Change From Baseline at 4 Months
기간: Baseline, 4 Months
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Each participant will do a one repetition maximum.
Participants will perform a leg press.
The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.
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Baseline, 4 Months
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Leg Extensions Test; Change From Baseline at 4 Months
기간: Baseline, 4 Months
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Each participant perform a one repetition maximum .
Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs.
The exercise is done using a machine called the Leg Extension Machine.
This resistence is measured in pounds.
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Baseline, 4 Months
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Leg Curl Test; Change From Baseline at 4 Months
기간: Baseline, 4 Months
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Each participant will perform a one repetition maximum.
Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles.
The exercise involves flexing the lower leg against resistance towards the buttocks.
This resistence is measured in pounds.
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Baseline, 4 Months
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Chest Press; Change From Baseline at 4 Months
기간: Baseline, 4 Months
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Each participant will perform a one repetition maximum.
Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position.
This resistence is measured in pounds.
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Baseline, 4 Months
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Shoulder Press Test; Change From Baseline at 4 Months
기간: Baseline, 4 Months
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Each participant will perform a one repetition maximum.
Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead.
This resistence is measured in pounds.
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Baseline, 4 Months
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Seated Row Test; Change From Baseline at 4 Months
기간: Baseline, 4 Months
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Each participant will perform a one repetition maximum.
Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position.
This resistence is measured in pounds.
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Baseline, 4 Months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kevin R Vincent, M.D. Ph.D., University of Florida Department of Orthopaedics and Rehabilitaion
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
2010년 11월 1일
기본 완료 (실제)
2013년 6월 1일
연구 완료 (실제)
2013년 6월 1일
연구 등록 날짜
최초 제출
2010년 11월 5일
QC 기준을 충족하는 최초 제출
2010년 11월 19일
처음 게시됨 (추정)
2010년 11월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 12월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 11월 19일
마지막으로 확인됨
2014년 11월 1일
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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