Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score
研究概览
简要总结
The purpose of this study is to examine the effectiveness of standard physical therapy and an internet-based exercise program for people with knee osteoarthritis (OA). Both of these programs will be compared to a "waiting list" control group. The investigators hypothesize that both treatments will result in greater improvement than the control condition and that the treatments will be similarly effective. The investigators also expect that some patients may do better with one treatment type or another and will explore this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee Osteoarthritis
排除标准
- •no internet access
- •rheumatoid arthritis, lupus, or any other rheumatic condition
- •severe fibromyalgia
- •gout in your knees
- •on a waiting list for joint replacement surgery, or are you planning to have joint replacement surgery during the next year
- •total knee replacement surgery, other knee surgery, a torn meniscus in your knee, or a torn ACL in your knee during the past 6 months
- •hospitalized for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 3 months
- •currently undergoing physical therapy for knee OA
- •meeting current recommendations for physical activity levels
- •participating in another interventional study related to knee osteoarthritis or a study that involves physical activity
研究组 & 干预措施
Standard Physical Therapy
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
干预措施: Physical Therapy (Behavioral)
Internet Based Exercise Training
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
干预措施: Internet Based Exercise Training (Behavioral)
Wait list control
no intervention
结局指标
主要结局
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score
时间窗: baseline, 4 months, and 12 months
Change over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function.
次要结局
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale(baseline, 4 months, and 12 months)
- Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument(baseline, 4 months, and 12 months)