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临床试验/NCT02489383
NCT02489383Unknown不适用

Comparison to Short and Medium-term Effects of Continuous and Interval Aerobic Exercise Training in Improving Aerobic Capacity, Psychosocial Factors and Impact on the Level of Physical Activity in Patients With Asthma Moderate and Severe

University of Sao Paulo General Hospital4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
4
主要终点
Endurance test

研究概览

简要总结

The treatment of asthma is based in clinical control. However, previous studies have been shown that patients that participate of the programs of regular or aerobic continuous exercise training (CT) presented improvements in the physical conditioning, and quality life, as well as decreased the levels of anxiety and depression, reduced the oxide nitric exhaled and leukocyte migration at the airways and reduced the airway hyperresponsiveness. The regular exercise also is important part in the rehabilitation of other lung disease as well as chronic obstructive pulmonary disease (COPD). Additionally, others studies have been shown the effects of high intensity interval training (IT) in the pulmonary rehabilitation of COPD patients, that after performed IT presented reduction of dyspnea, and increase the physical capacity. In this sense, the impact of IT in the asthmatic patients at the present moment is poorly studied, and necessity of the more investigation to prove the efficiency of this training model for asthma patients.

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详细描述

The present study will compare the impact of IT and CT in patients with moderate or severe asthma, and investigate what is the most efficient and increases the physical capacity, and quality of life and reduces the inflammatory mediators.

Sixty asthmatic adults will be randomly assigned into two groups: CT (Continuous training) or IT (Interval training). CT will have treatment 2x week, 40 min./session, 60-75% of maximum heart rate intensity and IT also 2x week, 40 min./session, 80-140% of the maximum load intensity, both performed in ergometer cycle by 24 weeks.

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
20 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Asthma moderate and severe
  • Asthma will diagnosed (Global Initiative for Asthma - GINA)
  • Body Mass Index (BMI) < 35kg/m2
  • Medical Treatment for at least 6 months
  • Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)

排除标准

  • Cardiovascular, musculoskeletal or other different chronic lung diseases
  • Active cancer

研究组 & 干预措施

Continuous Exercise Training

Active Comparator

The interventions of active comparator will be education program and exercise training.

干预措施: Continuous Exercise Training (Other)

Continuous Exercise Training

Active Comparator

The interventions of active comparator will be education program and exercise training.

干预措施: Education Program (Behavioral)

Interval Exercise Training

Active Comparator

The interventions of active comparator will be education program and exercise training.

干预措施: Interval Exercise Training (Other)

Interval Exercise Training

Active Comparator

The interventions of active comparator will be education program and exercise training.

干预措施: Education Program (Behavioral)

结局指标

主要结局

Endurance test

时间窗: After 3 months of intervention

Measurements at isotime: at identical work rates before and after training, heart rate, perception exertion and dyspnea.

次要结局

  • Health related quality of life(Before and after 3 months os intervention, and after 3 months of follow up)
  • Nitric oxide exhaled measurement(Before and after 3 months of intervention)
  • Analysis of cortisol in the serum(Before and after 3 months of intervention)
  • Level of physical activity(Before and after 3 months of intervention, and after 3 months of follow up)
  • Lung function(Before and after 3 months os intervention, and after 3 months of follow up)
  • Quantification of Inflammatory mediators(Before and after 3 months of intervention)
  • Clinical Control(Before and after 3 months os intervention, ans after 3 months of follow up)
  • Level of depression and anxiety(Before and after 3 months os intervention, and after 3 months of follow up)
  • Physical capacity(Before and after 3 months os intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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