Comparison of Cardiovascular Training Versus Resistance Training In Patients With Systemic Lupus Erythematosus: Controlled Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Life quality
研究概览
简要总结
The purpose of this study is to check the improvement in quality of life in patients with systemic lupus incorporated into a routine of physical activity.
Randomized controlled blinded trial, 63 patients aged 42.9 ± 14.4 and diagnosis of systemic lupus erythematosus (SLE) according to the criteria of the College American Rheumatology, 1997. After randomization patients were allocated into 3 groups, control group (CG) (n = 21), training cardiovascular (CT) (n = 20), resistance training (RT) (n = 22), performing 12 weeks of intervention with a frequency of three times weeks and were evaluated at two different times (T0 and T12). As primary outcome quality of life was assessed by the inventory Generic Assessment of quality of life by the Medical Outcomes Study 36 -- Healthy ItemShort Form Survey (SF36) and as secondary outcomes functional capacity evaluation of pain symptoms (visual scale analogue pain [VAS]), intensity of symptoms of depression (Beck Depression Inventory [BDI]), index of disease activity (Systemic Lupus Disease Activity Inventory Erythmatodud [SLEDAI]), capacity aerobic (walking test of 12 minutes [T12]), subjective perception effort (subjective scale of Borg [Borg]), limb muscle strength lower (analog dynamometer [strength]), electrical activity member lower (surface electromyography [EMG]), amount of products (inventory amount of Medicines).
详细描述
Will be selected 60 patients of both genders aged between 18 -55 years, with make the diagnosis of SLE by the criteria of the Americam College of Rheumatology revised in 1997 and that are not physically active.
After screening, patients will read and sign the informed consent form. The study will be submitted to the ethics committee of the Federal University of São Paulo / Escola Paulista de Medicina.
Randomization will be done by a secretary using a computer program specifically for this purpose, where the groups will be divided into intervention and control. The random allocation will be maintained using opaque sealed envelopes, which will open at the time of intervention.
Control group will not perform any type of training. Since the experimental group will be divided into two groups, cardio training (CT) and endurance exercise training (ET).
Evaluation will be conducted at the beginning and end of 12 weeks by two raters blind (who will not know to which groups, individuals were allocated) that will use the following tools:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(American College of Rheumatology). It is necessary to have the presence of room between the elevens criteria for diagnosis:
- •malar erythema
- •discoid lesions
- •photosensitivity
- •oral or nasal ulcers
- •arthritis
- •serositis
- •neurological
- •hematological
- •immunological changes
- •antinuclear antibodies.
排除标准
- •Patients with hemoglobin level 10gm/dL, sequelae of cardiovascular events, - Respiratory diseases (pulmonary hypertension, pulmonary fibrosis
- •Bronchitis, asthma, emphysema)
- •Heart failure (NYHA> II)
- •History of myocardial ischemia or heart
- •Blood pressure> 100 mm Hg.
结局指标
主要结局
Life quality
时间窗: 12 weeks
次要结局
- Strength(12 weeks)
- Electromyography(12 weeks)
- Pain(12 weeks)
- Aerobic capacity(12 weeks)