Clinical trial NCT03705702: Behavioral Intervention to Increase Physical Activity in Patients With Asthma
Official title: Effects of Behavioral Intervention to Increase Physical Activity on the Asthma Clinical Control: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Physical activity
Behavioral intervention
Asthma clinical control
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2018-10-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in asthma clinical control
timeFrame: Change from baseline asthma clinical control at 8 weeks of intervention
Secondary outcomes:
measure: Change in physical activity levels
timeFrame: Change from baseline physical activity levels at 8 weeks of intervention
measure: Change in health related quality of life
timeFrame: Change from baseline health related quality of life at 8 weeks of intervention
measure: Change in asthma exacerbation
timeFrame: Change from baseline asthma exacerbation at 8 weeks of intervention
measure: Change in sleep quality
timeFrame: Change from baseline sleep quality at 8 weeks of intervention
Other outcomes:
measure: Pulmonary function
timeFrame: At baseline
measure: Change in anthropometric indexes
timeFrame: Change from baseline anthropometric indexes at 8 weeks of intervention
measure: Change in body composition
timeFrame: Change from baseline body composition at 8 weeks of intervention
measure: Change in psychosocial symptoms
timeFrame: Change from baseline psychosocial symptoms at 8 weeks of intervention
Locations:
city: São Paulo
country: Brazil
facility: Clinical Hospital of São Paulo University medical school (HCFMUSP)
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Celso RF Carvalho, PhD
role: STUDY_DIRECTOR
References:
citation: Freitas PD, Passos NFP, Carvalho-Pinto RM, Martins MA, Cavalheri V, Hill K, Stelmach R, Carvalho CRF. A Behavior Change Intervention Aimed at Increasing Physical Activity Improves Clinical Control in Adults With Asthma: A Randomized Controlled Trial. Chest. 2021 Jan;159(1):46-57. doi: 10.1016/j.chest.2020.08.2113. Epub 2020 Sep 12.