Behavioral Intervention to Increase Physical Activity in Patients with Asthma: Identifying the Profile of Responders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in physical activity levels
研究概览
简要总结
To identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity.
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. After two days of evaluations, with an interval of 7 days between them, the participants will be included in a behavioral intervention program to increase physical activity for 8 weeks (once a week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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;
- •Partially/uncontrolled asthma;
- •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.
研究组 & 干预措施
Behavioral Intervention
Participants will undergo an eight-week behavioral intervention protocol (once a week) aimed at increasing the level of physical activity, consisting of a brief educational program: brief education for asthma and benefits of physical activity and behavioral intervention based on Social Cognitive Theory and the Theory of Stages of Behavior Change.
干预措施: Behavioral Intervention to Increase Physical Activity (Behavioral)
结局指标
主要结局
Change in physical activity levels
时间窗: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Physical activity will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.
次要结局
- Change in body composition - Skeletal muscle mass(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
- Change in asthma clinical control(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
- Change in sedentary behaviour(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 body composition - Fat-free mass(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 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 body composition - Visceral adiposity area(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