Influence of Weight Loss or Exercise on CARtilage in Obese Knee Osteoarthritis Patients: a Randomized Controlled Trial (CAROT).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.
The two diseases intertwine in several ways. The evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. The two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle.
There is a link between treatments of these two diseases as well. There is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring OA, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. This trial has two phases, the first (16 weeks) consisting of a dietary intervention with low-energy diet and the second (52 weeks) a randomized, three group (each n>50 patients) controlled study of maintenance of weight loss by either continuing dietary instruction, exercise, or a control group. The hypothesis is that maintenance of an initially induced weight loss is dependent on attention rather than any specific therapy.
详细描述
Any patient with osteoarthritis (OA)of the knee and concomitant obesity will be considered for participation. Eligible for this study will be patients with radiographical knee OA. Exclusion criteria are recent or planned knee operations, alloplasties in both knees, ongoing or planned alternative interventions against obesity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >=30
- •Radiographical knee OA
- •Age >=50
- •Spoken Danish
- •Motivated for weight loss
排除标准
- •Bilateral Alloplasty of the knees
- •Ongoing or planned surgery
- •Ongoing or planned alternative weight loss programme
- •Intellectual disability
结局指标
主要结局
Pain
时间窗: 16 weeks, 68 weeks
OMERACT-OARSI response criterion
时间窗: 16 weeks, 68 weeks
次要结局
- Weight change(8 weeks, 16 weeks, 68 weeks)
- Gait analysis(16 weeks, 68 weeks)
- MRI(16 weeks, 68 weeks)
- Ultrasound(16 weeks, 68 weeks)
- Collagen markers(16 weeks, 68 weeks)
- Metabolic syndrome(8 weeks, 16 weeks, 68 weeks)
- KOOS(16 weeks, 68 weeks)
研究者
Henning Bliddal
professor
Frederiksberg University Hospital