An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Time spent in physical activity
研究概览
简要总结
The aims of this study are to investigate the effectiveness of an online behavior change (BC) intervention in increasing physical activity (PA) and reducing sedentary behavior in adults with asthma, as well as, in improving other clinical outcomes, in short and medium term. In this single-blind randomized clinical trial, patients with clinically stable moderate to severe asthma, who are physically inactive and do not have cardiovascular and/or osteoneuromuscular impairments will be randomized into control (CG) or intervention (IG) groups (23 in each group). Both groups will carry out a minimum educational program. Additionally, the IG will receive weekly individual and/or group online sessions for 12 weeks of motivation-based BC intervention to promote PA and reduce sedentary behavior, based on both self-determination theory (SDT) and transtheoretical model (TTM). The IG will also receive a pedometer with specific strategies related to it. Both groups will be reassessed immediately after the intervention as well as 6 months after the end of the intervention. The primary outcomes are PA and sedentary behavior, which will be objectively assessed by a triaxial accelerometer (Actigraph wGT3X-BT). Secondary outcomes are: asthma control, functional capacity, quality of life, sleep quality and symptoms of anxiety and depression.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people aged from 18 to 60 years
- •diagnosis of moderate to severe asthma, who underwent drug treatment for at least 6 months
- •clinical stability for at least 1 month (without hospitalizations, emergency care use or medication changes)
- •absence of cardiovascular and/or osteoneuromuscular diseases that could interfere/hinder the performance of tests and physical activity
- •absence of lung diseases other than asthma
- •preserved cognitive function
- •non-smokers or ex-smokers with <10 pack-years
- •report being physically inactive in accordance with current physical activity guidelines
- •able to make video calls through any platform and/or free app available
排除标准
- •presence of any new orthopedic limitation that hinders the performance of physical activity during the study
- •perform ≥150 minutes per week of moderate to vigorous physical activity during the initial assessment
结局指标
主要结局
Time spent in physical activity
时间窗: 12 weeks from randomization
Time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.
Time spent in sedentary behavior
时间窗: 12 weeks from randomization
Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
Number of steps per day
时间窗: 12 weeks from randomization
Number of steps per day measured by a triaxial activity monitor
次要结局
- Asthma symptoms and exacerbations(36 weeks from randomization)
- Asthma medication use(36 weeks from randomization)
- Time spent in sedentary behavior(36 weeks from randomization)
- Sit-To-Stand test(36 weeks from randomization)
- Quality of life score(36 weeks from randomization)
- Time spent in physical activity(36 weeks from randomization)
- Asthma control(36 weeks from randomization)
- Number of steps per day(36 weeks from randomization)
- 4-Metre Gait Speed test(36 weeks from randomization)
- Motivational regulations(36 weeks from randomization)
- Incremental Step Test(36 weeks from randomization)
- Timed Up-and-Go test(36 weeks from randomization)
- Sleep quality(36 weeks from randomization)
- Basic psychological needs(36 weeks from randomization)
- Anxiety and depression symptoms(36 weeks from randomization)
- Lung function(36 weeks from randomization)
研究者
Karina Furlanetto
Professor
Universidade Norte do Paraná