Efficacy of Strength and Aerobic Exercise on Patient-reported Outcomes in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Knee-related quality of life
研究概览
简要总结
The overall contribution of this study is to increase the knowledge of the efficacy of strength and aerobic exercise on knee related quality of life, knee pain, and physical function in patients with knee osteoarthritis (OA). Knee OA is one of the most important diseases within musculoskeletal conditions affecting a considerable number of people worldwide. This randomized controlled trial will involve one intervention group delivered strength exercises and one group delivered aerobic exercise (ergometer cycling). The two intervention groups will be compared to a control group undergoing usual care. Cost-effectiveness analysis will be performed comparing the three groups. The study is funded from The Research Council of Norway.
详细描述
The trial aimed to recruit 207 study participants randomly allocated to three arms. The participants had to have symptomatic knee osteoarthritis verified by grade 2-3 using the Kellgren and Lawrence radiographic classification system, and they had to have knee pain most of the days the last month and fulfil 2/3 of the ACR clinical criteria. Participants with other serious comorbidities or self-reported BMI >35 were included.
The interventions consisted of structured strength training program over 12-14 weeks, and a structured stationary cycling program for 12-14 weeks.
Primary outcome was the KOOS knee-related quality of life subscale at the 1 year follow-up. Secondary outcomes were other patient reported outcomes, muscle strength, and peak oxygen consumption at the 4-month and 1 year follow-up, and over time (1-year).
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 (Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men aged 35-70 years
- •Clinical knee OA according to the American College of Rheumatology Clinical Criteria
- •Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)
排除标准
- •Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
- •Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
- •Known coronary heart diseases or cancer
- •Body mass index > 35
- •Scheduled for surgery in any joint
- •Known mental or psychologic diseases
- •Known drug abuse
- •Persons who already perform sports related moderate physical activity more than two times a week
- •Contraindications for magnetic resonance imaging (specific point list at Oslo University Hospital, radiographic department)
- •Not speaking Norwegian language
结局指标
主要结局
Knee-related quality of life
时间窗: 1 year
Primary outcome for the study will be the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale). 0 is very poor knee-related quality of life, while 100 indicates normal knee-related quality of life.
次要结局
- Knee function(4 months and 1 year)
- Health-related quality of life(4 months and 1 year)
- Radiographic osteoarthritis progression(2 years)
研究者
Britt Elin Øiestad
Principal Investigator
Oslo University Hospital