Effect of Short-term Negative Energy Balance With or Without Exercise on Systemic Biomarkers in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in hsCRP
研究概览
简要总结
The investigators are looking at the effects of energy restriction, with or without exercise on markers of inflammation in individuals with knee osteoarthritis. There will be a 4 week 'wash-in' period where participants will maintain their normal lifestyle, followed by a 4 week 'intervention period' where participants will be randomised into either the diet alone group or the diet plus exercise group.
详细描述
Knee Osteoarthritis is a condition that causes pain, reduced physical function and quality of life. Long-term studies have shown that exercise and substantial weight loss can cause improvements in these factors. Individuals with knee Osteoarthritis might have changes in their joint that can be seen with x-ray images. However, this is not guaranteed, and imaging does not always detect changes that occur with interventions that cause improved symptoms. As a result, there is interest in biological markers (biomarkers) as another way of monitoring Osteoarthritis. These markers can be examined in biological tissues, with samples measured in blood easier to obtain than those taken from the fluid within the joint itself. Historically, Osteoarthritis was thought of as a disease caused by mechanical factors but we are now aware that inflammation also plays a part.
Therefore, the investigators aim to test a short -term diet/exercise intervention that has been show to improve inflammation in other populations, in individuals with knee osteoarthritis. Importantly, this will allow the investigators to see if reducing food intake alone or doing this with regular exercise can improve outcomes without substantial weight loss. The investigators will ask individuals to participate in one of two groups where they will first be asked to continue their normal lifestyle for 4 weeks to check the stability of outcomes. The investigators will then ask individuals to either reduce their food intake by 5000 calories per week, or do this while also completing moderate intensity cycling exercise 5 times a week for 4 weeks. At the start and end of each period the investigators will collect a blood sample to assess markers of inflammation and disease related processes. The investigators will also conduct questionnaire measurements, tests of physical function and experimental pain and scan participants to establish body composition.
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
- 45 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or post-menopausal females
- •Clinically diagnosed with knee Osteoarthritis including radiographic confirmation
- •Oxford Knee Score ≥20 to ≤35 for index knee
- •Aged 45-69 years
- •BMI ≥27.5kg/m2 to ≤40.0 kg/m2
- •Daily physical activity level <2.00
排除标准
- •Inability to undertake cycling exercise safely
- •Use of prescribed anti-inflammatory medication
- •Current smoker (or having quit <6months ago)
- •Has a diagnosis of diabetes or other metabolic disorder
- •Use of other medications that might interfere with study outcomes
- •Recent (within last 3 months) change in body mass of >5%
- •Currently engaged in an ongoing programme of physiotherapy treatment
- •Currently on waiting list or having had surgery for Osteoarthritis on the index knee (prior OA related surgery permitted on other knee as long as this is greater than 12 months prior to enrolment)
- •Having had major hip/knee surgery within preceding 12 months
- •Individuals with a blood pressure of greater than 180/110
- •Currently pregnant or intending to become pregnant during the study
研究组 & 干预措施
Diet Only
Reduced calorie intake by 5000kcals per week over a 4 week period
干预措施: Diet Only (Other)
Diet plus Exercise
Reduced calorie intake by 5000kcals per week over 4 weeks with the addition of five 30 minute exercise sessions per week on a cycle ergometer. The exercise in intensity will be progressive and perceptually based and monitored by the investigators.
干预措施: Diet plus Exercise (Other)
结局指标
主要结局
Change in hsCRP
时间窗: 0, 4 and 8 weeks
Measured in mg/L via immunoassay
次要结局
- 40m fast paced walk(0, 4 and 8 weeks)
- Other Systemic Biomarkers(0, 4 and 8 weeks)
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)(0, 4 and 8 weeks)
- EQ-5D-5L Health Questionnaire(0, 4 and 8 weeks)
- SF-36 Questionnaire(0, 4 and 8 weeks)
- Visual Analogue Scale (VAS) Pain(0, 4 and 8 weeks)
- 30-second chair stand test(0, 4 and 8 weeks)
- Stair climb(0, 4 and 8 weeks)
- Timed up and go test(0, 4 and 8 weeks)
- Mechanical Detection Threshold(0, 4 and 8 weeks)
- Pressure Pain Threshold(0, 4 and 8 weeks)
- Body Mass Index(0, 4 and 8 weeks)
- Hip and Waist Circumference(0, 4 and 8 weeks)
- Body Composition(0, 4 and 8 weeks)
- Markers of metabolic health(0, 4 and 8 weeks)
研究者
James Bilzon
Professor James Bilzon
University of Bath