Strengthening Exercise and Quadriceps Force During Walking
A Study of Strengthening Exercise on Quadriceps Force During Walking
This is a longitudinal, randomized, controlled interventional multi centric study on the effects of lower leg strengthening exercise on quadriceps force during walking in people with knee osteoarthritis. At each study centre twenty subjects will be included, for a total of 40 participants. Subjects will be randomized equally (1:1) into 1 active arm and 1 control arm.
The objective of the study is to evaluate the effect of twelve weeks of quadriceps strengthening on the mechanical output of the quadriceps during locomotion. A secondary purpose is to explore the relationship between quadriceps strengthening and compressive knee loadings. The hypothesis is that quadriceps strength training will not change quadriceps force, power, and work in locomotion in people with knee osteoarthritis.
Primary outcome is quadriceps force during walking, secondary outputs are quadriceps power and work and knee compressive loads during walking. Explorative measures are isometric and concentric isokinetic leg muscle strength, radiographic score of the knee (Kellgren and Lawrence), a one-leg rise from chair test (maximum number of reps) and a lateral step-up test (maximum number of reps).
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
A medical doctor will perform the screening of potential participants. Subjects must meet the following inclusion criteria to be eligible for study entry:
- Knee OA diagnosed according to the American College of Rheumatology criteria (26), with clinical symptoms and radiographically verified tibio-femoral osteoarthritis in one or both knees.
- Aged between 40 and 65 yrs.
- Untrained (i.e. less than 2 hours of exercise per week)
- Subject must not be using assistive walking device
- Willing and able to complete study visits and procedures
- Willing to hold activity and exercise level generally consistent during the study except that encompassed in the study.
- In general good health, in the opinion of the investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the medical doctor at the screening visit.
- A body mass index (BMI) of 19<BMI≤32kg/m2
- Speaks, reads and writes Danish and/or English language
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria will be ineligible for study entry:
- Subjects depending on walking device
- Pregnant or breastfeeding
- Radiographic evidence of Patello-femoral knee OA only (and no tibio-femoral OA).
- History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis)
- Planned surgical procedure during the duration of the study
History or diagnosis of musculoskeletal injuries or pathologies, including but not limited to:
- Anterior cruciate ligament injuries
- Meniscal injuries related to trauma (degenerative changes allowed)
- Patellofemoral Pain Syndrome
- Low back pain
History, diagnosis, or signs and symptoms of clinically significant cardiovascular disease, including but not limited to:
- Ischemic heart disease
- Arthrosclerosis
- Peripheral artery disease
- History, diagnosis, or signs and symptoms of diabetes
History, diagnosis, or signs and symptoms of neurological disorders including but not limited to
- Stroke
- Parkinson's disease
- Multiple sclerosis
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 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 |
|---|---|
|
无干预：控制组
无干预组
|
|
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有源比较器：Strength training group
The knee extension strength training intervention period is 12 weeks with training sessions three times per week.
|
The exercises will be performed in standard strength training equipment.
Prior to each of the strengthening exercise sessions, a warm up phase is performed by 5-10 minutes of ergometer cycling at a moderate intensity.
Muscle strengthening exercises will be performed according to the standard progressive resistance and overload principle.
The exercise programme consists of three exercises performed with three sets of 10 repetitions at 60%-85% of patient's 10RM.
Training load will be progressed by means of bi-weekly estimates of muscle strength to ensure a constant load of 60%-85% RM.
Exercises are: 1. Leg extension, 2. Leg press, and 3. Forward lunges.
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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 |
|---|---|---|
|
Change from baseline in peak quadriceps force during walking at 12 weeks
大体时间：Baseline and at 12 weeks
|
Estimates of the quadriceps muscle forces during locomotion are calculated using a biomechanical model based on data from gait analysis
|
Baseline and at 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in quadriceps power and work during walking at 12 weeks
大体时间：Baseline and after 12 weeks
|
Estimated from gait analysis
|
Baseline and after 12 weeks
|
|
Change from baseline in knee compressive force during walking at 12 weeks
大体时间：Baseline and after 12 weeks
|
Estimated from biomechanical modelling of data from gait analysis
|
Baseline and after 12 weeks
|
合作者和调查者
调查人员
- 首席研究员：Paul Devita, MSc, PhD、The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum Greenville, U.S.A.
- 研究主任：Marius Henriksen, PhD、The Parker Institute, Frederiksberg University Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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