Clinical and Tissue Outcomes of a Biomechanical Exercise Program for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Lower Extremity Function
研究概览
简要总结
Prescribing exercise for people with painful knee osteoarthritis (OA) is essential for pain management, improved function, and chronic disease prevention. Exercise that decreases joint exposure to damaging loading while eliciting adequate muscular activation for strength improvements is ideal. The purpose of this 3-arm RCT is to compare mobility, strength, pain, and MRI outcomes between the low-loading biomechanical exercise program (BE), a traditional exercise program for knee OA (TE), and a control group completing meditation classes (M).
详细描述
Osteoarthritis (OA) is a common joint disease affecting 1 in 10 Canadians. Osteoarthritis commonly presents in the knee joint and is associated with mobility limitations, pain, and an increased risk of other chronic health conditions such as heart disease. It is critical to implement exercise for people with knee OA as it can be an effective method for improving pain, mobility, and cardiovascular health. A biomechanical exercise program using static yoga postures has been established in the investigators lab based on minimizing damaging knee joint loads, while effectively exercising the musculature around the knee joint. The investigators pilot project (REB#13-510) showed that a 12-week yoga program using these biomechanical exercises improved pain and mobility while keeping the medial joint loading well below that experienced during normal level walking. The next step with this exercise program is to compare clinical and tissue outcomes with that of a regularly prescribed aerobic and strengthening program, as well as a control group completing meditation classes. The investigators aim to identify differences in clinical mobility performance outcomes, muscle and fat volumes using magnetic resonance imaging (MRI), and cartilage integrity using MRI between the three groups using a randomized controlled trial (RCT) design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •50 years of age or older
- •Knee pain on most days of the week
- •Less than 30 minutes of morning stiffness
- •Bony enlargement
- •Bony tenderness to palpation
- •Signs of inflammation
- •Able to safely climb 2 flights of stairs without aid
排除标准
- •Any other forms of arthritis
- •Osteoporosis
- •History of patellofemoral symptoms
- •Active non-arthritic knee disease
- •Knee surgery
- •Use of cane or walking aid
- •Unstable heart condition
- •Neurological conditions
- •Skin allergy to medical tape
- •Hip or ankle injuries in past 3 months
- •Any injuries that would prohibit participation in yoga
- •Ipsilateral hip or ankle conditions
- •Currently receiving cancer treatment
- •Currently pregnant
研究组 & 干预措施
Biomechanical Exercise (BE)
The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.
干预措施: Biomechanical Exercise (BE) (Other)
Traditional Exercise (TE)
The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.
干预措施: Traditional Exercise (TE) (Other)
Meditation Control (M)
The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.
干预措施: Meditation Control (M) (Other)
结局指标
主要结局
Change in Lower Extremity Function
时间窗: Week 1 and Week 13
The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. The LEFS is scored from 0 to 80 with higher scores represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.
次要结局
- Change in Mobility Performance (40m Walk Test)(Week 1 and Week 13)
- Change in Grip Strength (Absolute)(Week 1 and Week 13)
- Change in Self-reported Knee Pain(Week 1 and Week 13)
- Change in Depression Status(Week 1 and Week 13)
- Change in Arthritis-related Self-efficacy(Week 1 and Week 13)
- Change in Muscle and Fat Volume(Indented to be collected on week 1 and week 13)
- Change in Cartilage Morphology(Week 1 and Week 13)
- Change in Isokinetic Knee Extensor and Flexor Power(Week 1 and Week 13)
- Change in Mobility Performance (Six-Minute Walk Test)(Week 1 and Week 13)
- Change in Mobility Performance (Timed Up and Go Test)(Week 1 and Week 13)
- Change in Mobility Performance (Stair Ascent)(Week 1 and Week 13)
- Change in Inflammatory Markers (CRP)(Week 1 and Week 13)
- Change in Cardiovascular Fitness(Intended to be collected on week 1 and week 13)
- Change in Isometric Knee Extensor and Flexor Strength(Week 1 and Week 13)
- Change in Grip Strength (Relative)(Week 1 and Week 13)
- Change in Frailty Status(Week 1 and Week 13)
- Change in Mobility Performance (30-second Chair Stand Test)(Week 1 and Week 13)
- Change in Inflammatory Markers (IL6, TNF, IL10)(Week 1 and Week 13)