A Randomised Controlled Trial Assessing the Effects of a Six-week Exercise Programme on Fitness, Inflammation and Cardiovascular Risk in Women With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in DAS (Disease Activity Score)
研究概览
简要总结
This study is investigating whether a six-week exercise training programme, designed for patients with Rheumatoid Arthritis, improves disease activity, inflammation, cardiorespiratory fitness, muscle strength, flexibility and risk factors for cardiovascular disease. Twenty four patients will be randomly assigned to an intervention or control group (n=12 in each group). The intervention group will will undertake a fully supervised structured exercise training programme, consisting of both aerobic and strength training exercise, taking the form of two 70-minute group fitness classes per week for six weeks. These participants will also undertake a 30-minute walk in their own time. The control group will continue to go about their normal daily activities. Measurements will be made before and after the intervention/control period, including assessments of disease activity (e.g., by gauging how swollen and tender patients' joints are using the Disease Activity Score(DAS) ) and assessments of fitness and/or physical functioning (e.g., 200 meter timed walk test, a strength test, a flexibility test, Health Assessment Questionnaire Disability Index (HAQDI)). Blood samples will also be collected from patients before and after the intervention/control period to measure markers of inflammation, such as C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR). The investigators will also measure other parameters that are linked to type II diabetes (e.g., fasting glucose concentration) and factors implicated in cardiovascular disease risk (e.g., lipid profile and resting blood pressure).
详细描述
Rheumatoid Arthritis (RA) is a multi-system autoimmune disease characterised by chronic inflammation (i.e., a persistent and inappropriate immune response). It primarily affects the joints, causing swelling, pain, reduced muscle strength and high biomarkers of inflammation such as C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). This immune response also results in accelerated atherosclerotic processes, decreased Bone Mineral Density (BMD) and damage to cartilage in the affected joints. Until the mid-1990s, patients with RA had traditionally been advised to avoid physical exercise, due to concerns it may result in progression of joint damage; hospital admission for bed rest was common practice. However, in the last 20 years, studies have shown that combined moderate-intensity aerobic exercise and strength training, can improve joint swelling, increase cardiorespiratory fitness and strength, without exacerbating pain or joint damage in patients with RA. Thus, the American College of Sports Medicine (ACSM) recommends that patients with RA walk or cycle for at least 30 minutes three times a week at a moderate intensity of 60% to 85% of maximum heart rate (HRmax) to improve cardiorespiratory fitness. The ACSM also recommends static or dynamic strength training of all large muscle groups twice weekly, performing three sets of 8-10 repetitions of 50% to 80% of one repetition maximum (1RM). While it is now established that exercise training can limit disease activity, and lower systemic inflammation, it is unclear whether short (e.g., six-weeks) and feasible exercise training programmes (e.g., two 70 minute sessions per week) elicit the same effects as the commonly employed interventions that are more demanding (e.g., 3-12 months; 3-5 sessions per week). In addition, it is unclear whether such a short intervention can modify other factors implicated in non-communicable disease, such as type II diabetes and cardiovascular risk (e.g., glucose control, lipid profile, blood pressure).
Objectives:
To examine if a six-week moderate intensity aerobic exercise and muscle strengthening programme:
- Results in changes in disease activity.
- Improves cardiorespiratory fitness, strength and flexibility.
- Reduces disease related inflammatory markers.
- Reduces blood pressure, improves lipid profile and improves glucose control.
Study Design:
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
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-69
- •Non-smokers
- •Diagnosis of Rheumatoid Arthritis for greater than 12 months
- •Stable Disease modifying medication for the preceding three months
- •Functional capacity class I-II
- •Able to use an exercise bicycle
- •Willing to exercise twice-weekly on a fixed schedule
- •Available for eight weeks between May and September 2016
排除标准
- •Cardiovascular disease (i.e. coronary heart disease, previous heart attack, angina, stroke or uncontrolled hypertension)
- •Major psychiatric illness, such as schizophrenia or major depression
- •A prosthetic hip or knee joint.
结局指标
主要结局
Change in DAS (Disease Activity Score)
时间窗: Before and after six-week intervention (approximately 8 weeks)
DAS-28 uses the number of swollen joints, the number of tender joints, the C-reactive Protein level and the patient's global assessment of well-being, scored out of 100, to calculate the disease activity score at that point in time. Based on the American college of rheumatology (ACR) a change of minus 20 % the DAS-28 score is considered a moderate response.
200m Walk-test to estimate Cardiorespiratory fitness
时间窗: Before and after six-week intervention (approximately 8 weeks)
Time taken to complete the 200 metre walk test before and after six-week intervention. Measured in seconds.
Strength of quadriceps muscles
时间窗: Before and after six-week intervention(approximately 8 weeks)
Using a Cybex dynamometer the investigators will measure the peak muscle torque of a concentric contraction of the quadriceps muscle. This is measured in Newtons metres (N. m)
Flexibility of hamstring muscles
时间窗: Before and after six-week intervention (approximately 8 weeks)
Assessed using the Sit and Reach Test box. The patient is seated with feet flat against the sit and reach box. The patient then reaches their arms forward toward the top of the box which has a scale starting at zero centimetres at the participant's ankle up to 40 centimetres beyond the participant's ankle. Increased measurement corresponds to increased hamstring flexibility. Three attempts are recorded and the average measurement in centimetres is recorded. This estimates flexibility of hamstring muscles.
Cardiovascular Risk Score
时间窗: Before and after six-week intervention (approximately 8 weeks)
This is calculated using an algorithm call the Q-Risk2 which is validated for use in the United Kingdom. It uses blood pressure, cholesterol level, smoking status, age, body mass index,ethnicity, and presence of rheumatoid Arthritis, chronic kidney disease and family history of heart disease, to predict the ten year risk of cardiovascular disease
Strength of hamstring muscles
时间窗: Before and after six-week intervention(approximately 8 weeks)
Using the Cybex dynamometer the investigators will measure the peak muscle torque of a concentric contraction of the hamstring muscles. This is measured in Newtons metres.
Blood pressure
时间窗: Before and after six-week intervention (approximately 8 weeks)
Measured on the left arm of the patient using a sphygmomanometer. The patient will be seated for at least 15 minutes with the arm supported at the level of the precordium. Three measurements will be made and the average recorded in millimetres of mercury (mmHg)
次要结局
- Fasting LDL-Cholesterol(Before and after six-week intervention (approximately 8 weeks))
- BMI (Body Mass Index)(Before and after six-week intervention (approximately 8 weeks))
- HBA1C (Glycated Haemoglobin 1C)(Before and after six-week intervention(approximately 8 weeks))
- Fasting HDL-Cholesterol(Before and after six-week intervention (approximately 8 weeks))
- CRP (C-Reactive Protein)(Before and after six-week intervention (approximately 8 weeks))
- ESR (Erythrocyte Sedimentation Rate)(Before and after six-week intervention (approximately 8 weeks))
- Fasting glucose(Before and after six-week intervention (approximately 8 weeks))
- Fasting total cholesterol(Before and after six-week intervention (approximately 8 weeks))
- The short form of the International Physical Activity Questionnaire (IPAQ)(Before and after six-week intervention (approximately 8 weeks))
- Fasting Triglycerides(Before and after six-week intervention (approximately 8 weeks))
- HAQDI (Health Assessment Questionnaire Disability Index)(Before and after six-week intervention (approximately 8 weeks))
研究者
Siobhan Graham
General Practitioner
Belfast Health and Social Care Trust