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Completed

NCT Number: NCT03705702

Behavioral Intervention to Increase Physical Activity in Patients With Asthma

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.

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Key information

Conditions

Asthma Behavior Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, 05360-160, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education program

Other

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.

behavioral intervention

Behavioral

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.

Primary outcomes

  1. Change in asthma clinical control

    Time frame: Change from baseline asthma clinical control at 8 weeks of intervention

    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.

Secondary outcomes

  1. Change in physical activity levels

    Time frame: Change from baseline physical activity levels at 8 weeks of intervention

    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).

  2. Change in health related quality of life

    Time frame: Change from baseline health related quality of life at 8 weeks of intervention

    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.

  3. Change in asthma exacerbation

    Time frame: Change from baseline asthma exacerbation at 8 weeks of intervention

    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

  4. Change in sleep quality

    Time frame: Change from baseline sleep quality at 8 weeks of intervention

    Sleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side).

Other outcomes

  1. Pulmonary function

    Time frame: At baseline

    Lung volumes will be assessed by spirometry

  2. Change in anthropometric indexes

    Time frame: Change from baseline anthropometric indexes at 8 weeks of intervention

    Height (m) and weight (kg) will be combined to report BMI (kg/m^2)

  3. Change in body composition

    Time frame: Change from baseline body composition at 8 weeks of intervention

    Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)

  4. Change in psychosocial symptoms

    Time frame: Change from baseline psychosocial symptoms at 8 weeks of intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • University of Sao Paulo

Registry information

Official study title

Effects of Behavioral Intervention to Increase Physical Activity on the Asthma Clinical Control: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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