Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma: a Randomized, Blinded Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in asthma clinical control
研究概览
简要总结
To compare the effects of aerobic training and behavioural intervention to increase physical activity in the clinical control of asthma and in the quality of life of patients with asthma.
详细描述
Adult participants of both genders with moderate to severe asthma, not physically active, will be evaluated after being informed about the study, agreeing and signing the informed consent form. Participants will be randomized to aerobic training or behavioral intervention group. Both interventions will consist of 8 weeks. Aerobic training will be performed on a treadmill (2xweek; 45 min/session). The behavioral intervention will be a program to increase physical activity (1xweek; up to 90 min / session). The maximum HR will be estimated according to the Tanaka's equation (208 - 0.7 x age).
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)
盲法说明
Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants not physically active;
- •Uncontrolled asthma (ACQ>1,5);
- •Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);
- •Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;
- •Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least 30 days;
- •Being using optimized drug therapy for asthma.
排除标准
- •Participation in another research protocol;
- •Difficulty in understanding any of the questionnaires used;
- •Practitioners of regular physical activity;
- •Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol;
- •Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;
- •Patients who are smokers or ex-smokers (who have quit smoking for less than 1 year or who have smoked more than 15 pack-years).
结局指标
主要结局
Change in asthma clinical control
时间窗: [Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ). The ACQ contains 7 items rated on a 7- point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control. Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.
次要结局
- Change in sedentary behaviour(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
- Change in physical activity levels([Time Frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention])
- Change in body composition - Weight(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
- Change in body composition - Fat mass(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
- Change in Health Factors Related to Quality of Life in Asthma(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
- Change in psychosocial symptoms(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
- Change in body composition - Visceral adiposity area(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention.)
- Change in body composition - Fat-free mass(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention])
- Change in body composition - Skeletal muscle mass(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention])
研究者
Celso R. Carvalho
Associate Professor
University of Sao Paulo General Hospital