Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
2014年11月19日 更新者：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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Gainesville、Florida、美国、32607
- UF&Shands Orthopaedics and Sports Medicine Institute
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
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
|
|
有源比较器：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.
|
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.
|
|
有源比较器：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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Six Minute Walk Test; Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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.
|
Baseline, 4 Months
|
|
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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.
|
Baseline, 4 Months
|
|
Leg Press Test; Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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.
|
Baseline, 4 Months
|
|
Leg Extensions Test; Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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.
|
Baseline, 4 Months
|
|
Leg Curl Test; Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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.
|
Baseline, 4 Months
|
|
Chest Press; Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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.
|
Baseline, 4 Months
|
|
Shoulder Press Test; Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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.
|
Baseline, 4 Months
|
|
Seated Row Test; Change From Baseline at 4 Months
大体时间：Baseline, 4 Months
|
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.
|
Baseline, 4 Months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kevin R Vincent, M.D. Ph.D.、University of Florida Department of Orthopaedics and Rehabilitaion
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2013年6月1日
研究完成 (实际的)
2013年6月1日
研究注册日期
首次提交
2010年11月5日
首先提交符合 QC 标准的
2010年11月19日
首次发布 (估计)
2010年11月22日
研究记录更新
最后更新发布 (估计)
2014年12月5日
上次提交的符合 QC 标准的更新
2014年11月19日
最后验证
2014年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
膝骨性关节炎的临床试验
normal activities and clinical care的临床试验
-
University of NottinghamEnhanced Recovery After Surgery Group (part of ESPEN)完全的
-
Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中