The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- Mobility Disability
研究概览
简要总结
The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA) compares a novel community-based exercise and dietary weight loss program to the Arthritis Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA) patients.
详细描述
Knee OA is a chronic, progressive, degenerative disease that affects over 20 million Americans, and is cited as the primary cause for activity restriction and physical disability in older adults. The joint damage and symptoms (i.e., pain, stiffness, and fatigue) accompanying symptomatic knee OA result in activity restriction, muscle atrophy, reduced quality of life and difficulty in performance of functional tasks.
Despite the well-established benefits of the Arthritis Foundation's (AF) exercise programs, recent evidence suggests that lifestyle interventions combining Exercise and Dietary Weight Loss (EX+DWL) results in superior improvements in key clinical outcomes in older, overweight or obese knee OA patients.
Primary Aim: To compare the effects of a novel community-based EX+DWL program to AF's Walk with Ease (WWE) EX intervention on improved mobility in knee osteoarthritis (OA) patients.
Secondary Aim: To compare the cost effectiveness and effects of the EX+DWL and WWE interventions on weight loss, pain, and quality of life.
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with knee OA: physician documented radiographic tibiofemoral OA of one or both knees
- •Overweight or Obese: BMI >25 and <40
- •Knee Pain and Risk for Mobility Disability: self-reported difficulty walking ¼ mile, climbing stairs, lifting or carrying groceries, or performing other household activities due to knee pain
- •Sedentary: sedentary lifestyle defined as currently participating < 20 minutes of weekly structured moderate intensity exercise occurring in bouts >10 min
- •Health Status: all participants must be free of severe heart or systemic disease that would make moderate intensity exercise participation unsafe
- •Age: > 50 years of age
- •Stability of Residence: does not plan to move out of the Columbus metropolitan area for the duration of the study
- •Consents: willing to give an informed consent and sign a HIPPA authorization form; (9) Physician Consent: treating rheumatologist and primary care physician provide medical consent for participation
- •Agreeableness: willing to accept randomization and complete all assessment and intervention procedures
排除标准
- •Health Status: any serious medical condition that precludes safe participation in an exercise program
- •Study Staff Judgment: Inability to complete the study protocol, in the opinion of the study staff, due to frailty, illness, or other reasons
结局指标
主要结局
Mobility Disability
时间窗: baseline up to 2 years
This will be assessed using the 400 meter walk test (400MWT), which is the time to complete 400m as quickly as possible (without running)
次要结局
- Anthropometric Battery(baseline up to 2 years)
- Functional Battery and Limitations(baseline up to 2 years)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline up to two years)
- Rand Medical Outcomes Study 36-item Short Form Health Survey (SF-36)(baseline up to two years)
- Dietary intake(baseline up to two years)
- Social Cognitive Process Measures(baseline up to two years)
- Change in physical activity(baseline up to two years)
- Cost effectiveness(baseline up to two years)
研究者
Brian Focht
Associate Chair, Associate Professor
Ohio State University