Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Adherence (in %)
研究概览
简要总结
This study evaluates the feasibility of a mindful walking intervention for management of knee osteoarthritis. Participants will be randomly assigned to receive one of two interventions i.e. mindful walking intervention or a self-care intervention.
详细描述
People with knee osteoarthritis have low levels of physical activity, especially walking activity. They also walk with abnormal walking biomechanics that are associated with greater knee loading. Therefore, it is important to increase the levels of walking activity in people with knee osteoarthritis, but also change their walking patterns to reduce knee loading.
This study will last 12 months and participants will be randomized into 2 groups. For the first 6-months, half of the participants will attend sessions at a community location that include training in mindful walking technique. The other half will meet for the same frequency and duration at a community location for education on osteoarthritis and its management (focusing on symptom management, importance of physical activity, weight management, etc.). Both groups will also receive a wrist-worn activity monitor and a smartphone application that they will use throughout the study. After 6-months all participants will be allowed to practice on their own.
All participants will complete gait analysis, knee MRI, questionnaires, physical function assessment at baseline and at 6-months. All participants will also complete questionnaires at 3,9, and 12 months. Weekly physical activity and knee pain data will be collected using the mobile health technology for 12- months.
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
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 50-80 years
- •BMI ≤40 kg/m2
- •Meet American College of Rheumatology clinical and/or clinical+radiographic criteria for knee osteoarthritis
- •Knee pain score ≥ 4 during last week
- •Predominantly medial knee pain
- •Predominantly medial knee radiographic osteoarthritis with or without radiographic patellofemoral osteoarthritis
- •Ability to ambulate for a minimum of 20 minutes, without any assistive device
- •Available for the study duration
- •Own a smartphone
- •Can speak and understand English
排除标准
- •Contraindications to exercise
- •Using orthotics for knee pain such as knee braces, wedge insoles
- •Knee injection in previous 3-months
- •Currently receiving physical therapy for knee pain
- •Planning major treatment for knee pain (e.g., physical therapy, surgery) in next 6 months
- •Self-reported joint diseases like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, etc.
- •Self-reported total joint replacement in any lower extremity joint
- •Self-reported neurological conditions like stroke, Parkinson's disease, etc.
- •Self-reported muscular disease like muscle dystrophy
- •Self-reported musculoskeletal or neurologic conditions that affect gait.
研究组 & 干预措施
MCG - Mindful Walking
Participants will be trained in mindful walking technique
干预措施: MCG (Behavioral)
SCG - Education and Self-Care
Participants will receive education in self-management of knee OA
干预措施: SCG (Behavioral)
结局指标
主要结局
Adherence (in %)
时间窗: 6-months
Measured as % of in-person training sessions attended by participants
Retention (in %)
时间窗: 6-months
Measured as the % of participants returning for the post-intervention assessment
次要结局
- Medial knee contact force during walking (in Newton)(Change from baseline to 6-months)
- Average Daily Activity Count(Change from baseline to 6-months)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale(Change from baseline to 6-months)
研究者
Deepak Kumar
Assistant Professor
Boston University Charles River Campus