Behavioral Intervention to Increase Physical Activity in Patients With Asthma
2020年4月13日 更新者：University of Sao Paulo General Hospital
Effects of Behavioral Intervention to Increase Physical Activity on the Asthma Clinical Control: a Randomized Controlled Trial
The health benefits of physical activity (PA) are well documented and include improving in cardiovascular, obesity, mental health and all-cause mortality.
Although higher levels of activity in patients with asthma are also associated with better outcomes, patients still avoid physical activity due to concern about exacerbating their asthma symptoms by the exercise induced bronchoconstriction (EIB), sustaining a vicious cycle of inactivity and worse asthma control.
Many studies have reported the benefits of supervised exercise training on several asthma outcomes, such as exacerbations, asthma control, cardiopulmonary fitness, airway inflammation and psychosocial symptoms; however, the translation of the improvements in the exercise capacity into increments in PA levels is less evident and still controversial.
Therefore, the hypothesis of this study is that behavioural interventions using strategies based on well-established psychosocial models are effective in increasing physical activity levels and decrease sedentary behaviour in adults with asthma, which will be associated with improvements in the asthma control.
研究概览
详细说明
This is prospective and randomized controlled trial (RCT) with 2 arms and blinded outcome assessments.
Forty-six moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either Control Group (CG) or Intervention Group (IG).
Both groups will receive similar educational program.
However, only the IG will be submitted to the behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool aiming to increase physical activity levels (total of 8 weekly goal-setting consultation, face-to-face, each lasting 40 minutes).
Before and after the interventions, clinical control of asthma, physical activity levels, health-related quality of life, asthma exacerbation, levels of anxiety and depression symptoms and anthropometric indices will be assessed.
Data about onset of asthma, comorbidities, lung function and asthma medication will be collected from the patient's medical record.
The data normality will be analyzed by Kolmogorov-Smirnov, and a two-way ANOVA with repeated measures with appropriate post hoc of Holm-sidak will be used to compare inter and intra-groups differences.
The significance level will be set to 5% for all tests.
研究类型
介入性
注册 (实际的)
46
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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São Paulo、巴西、05360-160
- Clinical Hospital of São Paulo University medical school (HCFMUSP)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Asthma moderate and severe with diagnosed according to the Global Initiative for Asthma (GINA) 2018
- Poorly controlled asthma (ACQ score > 1.5)
- Sedentary (< 150 min of moderate to vigorous physical activity/week)
- Medical treatment, for at least 6 months
- Clinically stable (i.e., no exacerbation or changes in medication for at least 30 days)
Exclusion Criteria:
- Cardiovascular, musculoskeletal or other chronic lung diseases
- Active Cancer
- Pregnant
- Uncontrolled hypertension or diabetes
- Current smoker or ex smoker (>10 pack-years)
- Psychiatric disease or cognitive deficit
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Intervention Group (IG)
The intervention of active comparator will be education program plus behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool.
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The educational program will consist of 2 classes held once a week, each lasting 90 minutes.
The classes will be based on an education videotape, presentations and group discussions.
The first class will address the asthma education, which will include information about the pathophysiology of asthma, medication and peak flow meter instructions, self-monitoring techniques, environmental control techniques and avoidance strategies.
The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active and maintain a healthy lifestyle.
The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting 40 minutes.
Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation.
According to their own PA data and the behavioural change stage, an individual action plan will be established with realistic goals to increase PA.
Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time.
Techniques such as weekly goal-setting, motivational interviewing, activity tracker vibration instructions, self-management, positive reinforcement, relapse prevention and strategies to overcome barriers will be included.
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假比较器：Control Group (CG)
The intervention of sham comparator will be an education program in asthma and physical activity recommendations.
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The educational program will consist of 2 classes held once a week, each lasting 90 minutes.
The classes will be based on an education videotape, presentations and group discussions.
The first class will address the asthma education, which will include information about the pathophysiology of asthma, medication and peak flow meter instructions, self-monitoring techniques, environmental control techniques and avoidance strategies.
The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active and maintain a healthy lifestyle.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in asthma clinical control
大体时间：Change from baseline asthma clinical control at 8 weeks of intervention
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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.
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Change from baseline asthma clinical control at 8 weeks of intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in physical activity levels
大体时间：Change from baseline physical activity levels at 8 weeks of intervention
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Physical activity and sedentary behaviour will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.
Sedentary behaviour will be quantify by the time spent sedentary (< 100 counts/min).
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Change from baseline physical activity levels at 8 weeks of intervention
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Change in health related quality of life
大体时间：Change from baseline health related quality of life at 8 weeks of intervention
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Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ).
The AQLQ consists of 32 items rated on a 7-point scale (1 = great deal, 7 = not at all) divided into the following 4 domains: activity limitations, symptoms, emotional function and environmental stimuli.
Higher AQLQ scores indicate a better quality of life, and treatments resulting in a 0.5-point increase in scores following an intervention are considered to be clinically effective.
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Change from baseline health related quality of life at 8 weeks of intervention
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Change in asthma exacerbation
大体时间：Change from baseline asthma exacerbation at 8 weeks of intervention
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Asthma exacerbation will be assessed by the following criteria: the use of ≥4 puffs of rescue medication per 24 hours during a 48-hour period, a need for systemic corticosteroids, an unscheduled medical appointment, and either a visit to an emergency room or hospitalization
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Change from baseline asthma exacerbation at 8 weeks of intervention
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Change in sleep quality
大体时间：Change from baseline sleep quality at 8 weeks of intervention
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Sleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side).
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Change from baseline sleep quality at 8 weeks of intervention
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Pulmonary function
大体时间：At baseline
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Lung volumes will be assessed by spirometry
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At baseline
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Change in anthropometric indexes
大体时间：Change from baseline anthropometric indexes at 8 weeks of intervention
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Height (m) and weight (kg) will be combined to report BMI (kg/m^2)
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Change from baseline anthropometric indexes at 8 weeks of intervention
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Change in body composition
大体时间：Change from baseline body composition at 8 weeks of intervention
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Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)
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Change from baseline body composition at 8 weeks of intervention
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Change in psychosocial symptoms
大体时间：Change from baseline psychosocial symptoms at 8 weeks of intervention
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Symptoms of anxiety and depression symptoms will be assessed by the Hospital Anxiety and Depression scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression).
Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale.
A score greater than 8/9 in each subscale suggests a diagnosis of either anxiety and/or depression.
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Change from baseline psychosocial symptoms at 8 weeks of intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Celso RF Carvalho, PhD、University of Sao Paulo General Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年10月5日
初级完成 (实际的)
2019年8月27日
研究完成 (实际的)
2019年11月30日
研究注册日期
首次提交
2018年10月4日
首先提交符合 QC 标准的
2018年10月8日
首次发布 (实际的)
2018年10月15日
研究记录更新
最后更新发布 (实际的)
2020年4月15日
上次提交的符合 QC 标准的更新
2020年4月13日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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