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Behavioral Intervention to Increase Physical Activity in Patients With Asthma

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Asthma

Treatments

Behavioral: Behavioral intervention
Other: Education Program

Study type

Interventional

Funder types

Other

Identifiers

NCT03705702
2016/17093-0 (Other Grant/Funding Number)
BIPAA

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups

Intervention Group (IG)
Active Comparator group
Description:
The intervention of active comparator will be education program plus behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool.
Treatment:
Behavioral: Behavioral intervention
Other: Education Program
Control Group (CG)
Sham Comparator group
Description:
The intervention of sham comparator will be an education program in asthma and physical activity recommendations.
Treatment:
Other: Education Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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