Effect of Active Exercise on Nutritional and Inflammatory Status, Muscle Metabolism and Cardiovascular Events in Maintenance Haemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mid-upper arm circumference of the non-internal fistula side（AC）
研究概览
简要总结
The goal of this clinical trial is to discuss the effects of physical activity on nutrition, inflammation, muscle metabolism, and the occurrence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. The main question it aims to answer is: can exercise improve nutritional and inflammatory status, enhance muscle strength, and reduce the incidence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis.
Researchers will compared active exercise group to conventional treatment group to see the impact of exercise on maintenance haemodialysis patients.
Participants will:
Choose low-intensity aerobic exercise workouts such as walking (no less than 8,000 steps per day) or jogging, swimming, Tai Chi, etc., according to their individual conditions, for no less than 30 minutes at a time, at least 3 times per week, and the intensity of the exercise should be based on an RPE score of 12 to 16.
详细描述
RPE: Rating of Perceived Exertion. RPE scores of 12 to 16 indicate the need for increased respiratory rate and depth during exercise, the ability to engage in conversational exchanges, light sweating, and a feeling of slight fatigue without reaching a state of exhaustion.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MHD more than 3 months, 3 times per week, 3-4h each time;
- •Urea clearance index (Kt/V) >1.2;
- •Stable condition, no serious infection, tumour and cardiovascular disease;
- •Willing to join the study and sign the informed consent form.
排除标准
- •Combined with serious heart and lung disease: such as repeated heart failure, severe arrhythmia, unstable angina pectoris, severe pericardial effusion, severe heart valve disease, hypertrophic cardiomyopathy, aortic coarctation, severe emphysema, pulmonary heart disease, severe pulmonary hypertension (average pressure of the pulmonary artery > 55mmHg), etc.;
- •Combined with chronic joints, muscles, or vascular disease can not be or is not suitable for regular exercise, such as cerebrovascular disease; combined chronic joint, muscle or vascular disease can not or are not suitable for regular exercise, such as cerebrovascular disease sequelae, serious lower limb joint damage, severe myopathy, deep vein thrombosis, etc.;
- •unwilling to cooperate with the movement of people
结局指标
主要结局
Mid-upper arm circumference of the non-internal fistula side（AC）
时间窗: Baseline and half year, 1 year
Measure the circumference of the non-internal fistula at the midpoint of the upper arm using a soft tape measure, in centimetres
upper arm muscle circumference of the non-internal fistula side（AMC）
时间窗: Baseline and half year, 1 year
AMC（cm）= AC(cm) - 3.14 x TSF（cm）
grip strength
时间窗: Baseline and half year, 1 year
Using a grip strength meter, with the patient seated and gripping the handle firmly with the palm of the non-internal fistulae side, measure twice and record the maximum grip strength value
triceps skin-fold thickness of the non-internal fistula side（TSF）
时间窗: Baseline and half year, 1 year
Measurement of the skinfold at the midpoint of the upper arm on the non-internal fistula side by using a skinfold thickness gauge, in centimetres
Incidence of cardiovascular and cerebrovascular events
时间窗: 1 year
Cardiovascular events include: heart failure episodes, sustained arrhythmias, myocardial infarction, and cerebrovascular events include: cerebral haemorrhage, cerebral infarction, transient ischaemic attack.
calf circumference
时间窗: Baseline and half year, 1 year
Measure the calf circumference using a soft tape measure, in centimetres
次要结局
- albumin(Baseline and half year, 1 year)
- c-reactive protein(Baseline and half year, 1 year)
- haemoglobin(Baseline and half year, 1 year)
- blood lipids(Baseline and half year, 1 year)
- prealbumin(Baseline and half year, 1 year)
研究者
Yunfeng Xia
Doctor
First Affiliated Hospital of Chongqing Medical University