Asthma Clinical Trial
Official title:
Effects of Behavioral Intervention to Increase Physical Activity on the Asthma Clinical Control: a Randomized Controlled Trial
Verified date | October 2018 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | November 30, 2019 |
Est. primary completion date | August 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Clinical Hospital of São Paulo University medical school (HCFMUSP) | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pulmonary function | Lung volumes will be assessed by spirometry | At baseline | |
Other | Change in anthropometric indexes | Height (m) and weight (kg) will be combined to report BMI (kg/m^2) | Change from baseline anthropometric indexes at 8 weeks of intervention | |
Other | Change in body composition | Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR) | Change from baseline body composition at 8 weeks of intervention | |
Other | 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. | Change from baseline psychosocial symptoms at 8 weeks of intervention | |
Primary | 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. | Change from baseline asthma clinical control at 8 weeks of intervention | |
Secondary | 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). | Change from baseline physical activity levels at 8 weeks of intervention | |
Secondary | 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. | Change from baseline health related quality of life at 8 weeks of intervention | |
Secondary | 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 | Change from baseline asthma exacerbation at 8 weeks of intervention | |
Secondary | 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). | Change from baseline sleep quality at 8 weeks of intervention |
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