Improving Physical Function and Quality of Life in Adults With Knee Osteoarthritis Utilizing an Online Live and Interactive Fitness Training Program (Vivo Knee OA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Primary Endpoint 1
研究概览
简要总结
Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice a week for 6 months and Usual Care Arm: meet with ATC and given Medbridge home exercise program for 6 months. All participants will be followed for 12 months, and will be assessed at 3-,6-, and 12-months. All participants will complete functional assessments, OA patient reported outcomes measures, quality of life, exercise self-efficacy, and fall risk questionnaires, and health care utilization report at each testing visit. A subset of Vivo participants will be asked satisfaction questions at the 3 and 6 month time points.
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
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55-85 years of age
- •Diagnosis of Osteoarthritis within the prior 6 months
- •Symptomatic OA defined as self-report:
- •Pain in the knee(s) on most days of the month
- •Difficulty with at least one of the following because of knee pain:
- •walking ¼ of a mile
- •climbing stairs
- •getting in and out of a car, bath, or bed
- •rising from a chair
- •or performing shopping, cleaning, or self-care activities
- •Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees
- •Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand
- •Ambulatory and community-dwelling
- •Sedentary or insufficiently active as measured by the PAVS
- •Access to Wi-Fi in defined exercise space
- •BMI of 20-34.9 kg/m2
- •Document medication specific to OA and knee pain
- •Willing and able to provide consent
排除标准
- •Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)
- •Diagnosis of dementia
- •Inability to complete ≥1 ADLs without assistance.
- •Knee surgery in the past 6 months
- •Severe osteoporosis T-score < -3.5
- •No concurrent enrollment in physical therapy for knee pain
- •No concurrent enrollment in the Intermountain Arthrofit program
- •Under the age of 55 or ≥85
- •Asymptomatic OA
- •Not having knee pain or having significant knee pain (WOMAC Pain score of ≤3 or ≥18)
- •KL Grade 1 or 4
- •BMI above 34.9 kg/m2 or ≤20 kg/m2
- •Participation in formal strength training more than 30 minutes a week in the past 6 months.
- •PAVS - Participating in 150 minutes per week of moderate intensity physical activity or 75 minutes of vigorous intensity activity, or an equivalent combination of moderate and vigorous intensity physical activity.
- •Co-morbid disease that would threaten safety or impair ability to participate in a live and interactive strength training program
- •Symptomatic or severe coronary artery disease; peripheral vascular disease
- •Untreated hypertension
- •Active cancer other than skin cancer
研究组 & 干预措施
Medbridge Home Exercise Program
干预措施: Medbridge Home program (Other)
Vivo Online Exercise program
干预措施: Vivo Online Exercise Program (Other)
结局指标
主要结局
Primary Endpoint 1
时间窗: 6 months post intervention
Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months.
次要结局
- Secondary Endpoint 2(6 months post intervention)
- Secondary Endpoint 4(6 months post intervention)
- Secondary Endpoint 1(6 months post intervention)
- Secondary Endpoint 5(6 months post intervention)
- Secondary Endpoint 7(6 months post intervention)
- Secondary Endpoint 8(6 months post intervention)
- Secondary Endpoint 3(6 months post intervention)
- Secondary Endpoint 6(6 months post intervention)