Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- interleukin 6
研究概览
简要总结
Inflammatory markers have been analyzed in several diseases of unknown etiology, in the expectation of increasing therapeutic perspectives. This possibility arises from the different levels of tissue injury with low-grade chronic inflammation that have been observed in studies in which the markers were not evaluated traditionally, and today have influenced clinical management.
The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS before and after aerobic and combined exercise training.
详细描述
Inflammatory markers have not been evaluated in adolescent idiopathic scoliosis (AIS), but this deformity potentially involves various musculoskeletal structures permanently, which justifies the analysis. A low-grade chronic inflammation may be related to the lower capacity in exercise performance observed in this population, which must be stimulated to perform standardized physical activity.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •thoracic curvature ≥ 45 degrees
- •indication for surgical treatment of spinal deformity
- •absence of pulmonary, cardiac, articular or neurological disorder, atopic dermatitis and previous or current allergy
- •agree part in the research with a assent statement and the person responsible with the consent form and informed
排除标准
- •acknowledged chronic liver or kidney inflammatory disease
- •use of corticosteroids, acetylsalicylic acid or other nonhormonal anti-inflammatory clinical or laboratorial evidence of infection
- •severe obesity
结局指标
主要结局
interleukin 6
时间窗: change from baseline in interleukin 6 at 3 months
Inflammatory Markers
interleukin 8
时间窗: change from baseline in interleukin 8 at 3 months
Inflammatory Markers
interleukin 1
时间窗: change from baseline in interleukin 1 at 3 months
Inflammatory Markers
次要结局
- oxygen saturation in six-minute walk test(change from baseline in oxygen saturation at 3 months)
- distance in six-minute walk test(change from baseline in distance at 3 months)
- systolic blood pressure in six-minute walk test(change from baseline in systolic blood pressure at 3 months)
- heart rate in six-minute walk test(change from baseline in heart rate at 3 months)
- respiratory frequency in six-minute walk test(change from baseline in respiratory frequency at 3 months)
- peak expiratory flow(change from baseline at 3 months)
- forced vital capacity (FVC)(change from baseline at 3 months)
- FORCED EXPIRATORY FRACTION (FEF25-75%)(change from baseline at 3 months)
- diastolic blood pressure in six-minute walk test(change from baseline in diastolic blood pressure at 3 months)
- forced expiratory volume in the first second (FEV1)(change from baseline at 3 months)
- forced expiratory volume in the first second (FEV1) / forced vital capacity (FVC)(change from baseline at 3 months)
- Borg scale in six-minute walk test(change from baseline in Borg scale at 3 months)
- maximal inspiratory pressure (MIP)(change from baseline at 3 months)
- maximal expiratory pressure (MEP)(change from baseline at 3 months)
- FORCED EXPIRATORY FRACTION (FEF25-75%) / forced vital capacity (FVC)(change from baseline at 3 months)
研究者
Profa. Dra. Vera Lúcia dos Santos Alves
PhD in health sciences
Faculdade de Ciências Médicas da Santa Casa de São Paulo