An interventional study of Education Program and Behavioral intervention in Asthma, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 46 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
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Exclusion Criteria:
The intervention of active comparator will be education program plus behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool.
Other: Education Program · Behavioral: Behavioral intervention
The intervention of sham comparator will be an education program in asthma and physical activity recommendations.
Other: Education Program
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.
Change in asthma clinical control
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.
Time frame: Change from baseline asthma clinical control at 8 weeks of intervention
Change in physical activity levels
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).
Time frame: Change from baseline physical activity levels at 8 weeks of intervention
Change in health related quality of life
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.
Time frame: Change from baseline health related quality of life at 8 weeks of intervention
Change in asthma exacerbation
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
Time frame: Change from baseline asthma exacerbation at 8 weeks of intervention
Change in sleep quality
Sleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side).
Time frame: Change from baseline sleep quality at 8 weeks of intervention
Pulmonary function
Lung volumes will be assessed by spirometry
Time frame: At baseline
Change in anthropometric indexes
Height (m) and weight (kg) will be combined to report BMI (kg/m\^2)
Time frame: Change from baseline anthropometric indexes at 8 weeks of intervention
Change in body composition
Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)
Time frame: Change from baseline body composition at 8 weeks of intervention
Change in psychosocial symptoms
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.
Time frame: Change from baseline psychosocial symptoms at 8 weeks of intervention
Plan to share: No
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University of Sao Paulo General Hospital