Physical Training in Patients With Idiopathic Inflammatory Myopathies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cardiopulmonary test
研究概览
简要总结
Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present study will assess the role of an exercise training program in patients with idiopathic inflammatory myopathies.
详细描述
To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of DM / PM according to the criteria of Bohan and Peter (1975)
- •Both genders and age ≥ 18 years
- •Use of prednisone ≤ 0.5 mg/kg/day in the last three months. The dose of prednisone will be kept fixed throughout the study
- •Physically inactive
排除标准
- •Disease relapsing
- •Neoplasia associated-myositis
- •Overlapping myositis
- •Use of lipid-lowering drugs
- •Diabetes mellitus
结局指标
主要结局
Cardiopulmonary test
时间窗: 12 weeks
Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion. VO2peak will be considered as the average of the final 30 s of the test. Ventilatory threshold (VAT) will be determined when ventilatory equivalent for VO2 (VE/VO2) increased without a concomitant increase in ventilatory equivalent for carbon dioxide (VE/VCO2). Respiratory compensation point (RCP) will be determined when VE/VO2 and VE/VCO2 increased simultaneously.
次要结局
- Functional muscle tests(12 weeks)
- Strength muscle tests(12 weeks)
- Patient/Parent Global Activity(12 weeks)
- Serum cytokines(12 weeks)
- Health Assessment Questionnaire(12 weeks)
- Muscle biopsies(12 weeks)
- Myositis Disease Activity Assessment Tool(12 weeks)
- Muscle enzymes(12 weeks)
- Manual Muscle Testing(12 weeks)
- Physician Global Activity(12 weeks)
研究者
Samuel Katsuyuki Shinjo, PhD
Principal Investigator
University of Sao Paulo