Behavioral Intervention to Increase Physical Activity in Patients With Asthma: Identifying Responders

Study Overview
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Brief Summary
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To identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity.

Detailed Description
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Adult participants of both genders with moderate to severe asthma, not physically active, will be evaluated after being informed about the study, agreeing and signing the informed consent form. After two days of evaluations, with an interval of 7 days between them, the participants will be included in a behavioral intervention program to increase physical activity for 8 weeks (once a week).

Official Title
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Behavioral Intervention to Increase Physical Activity in Patients With Asthma: Identifying the Profile of Responders

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Behavioral Intervention to Increase Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants not physically active; Partially/uncontrolled asthma; Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020); Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital; Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least , 30 days; Being using optimized drug therapy for asthma. Exclusion Criteria: Participation in another research protocol; Difficulty in understanding any of the questionnaires used; Practitioners of regular physical activity; Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal intervention study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention<br>Participants will undergo an eight-week behavioral intervention protocol (once a week) aimed at increasing the level of physical activity, consisting of a brief educational program: brief education for asthma and benefits of physical activity and behavioral intervention based on Social Cognitive Theory and the Theory of Stages of Behavior Change. | Behavioral: Behavioral Intervention to Increase Physical Activity<br>* 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. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active. The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting until 90 minutes. Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation. According to their own physical activity (PA) data and the behavioural change stage, an individual action plan will be established to increase physical activity. Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity levels | Physical activity will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt. | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sedentary behaviour | 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 at 8 weeks of intervention and at 16 weeks post intervention | 
| 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 at 8 weeks of intervention and at 16 weeks post intervention | 
| Change in Health Factors Related to Quality of Life in Asthma | 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 at 8 weeks of intervention and at 16 weeks post 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. | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 
| Change in body composition - Weight | Bioimpedance (Octopolar InBody 720). | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 
| Change in body composition - Fat mass | Bioimpedance (Octopolar InBody 720). | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 
| Change in body composition - Visceral adiposity area | Bioimpedance (Octopolar InBody 720). , Fat-free mass, and skeletal muscle mass will be calculated. | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 
| Change in body composition - Fat-free mass | Bioimpedance (Octopolar InBody 720). | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 
| Change in body composition - Skeletal muscle mass | Bioimpedance (Octopolar InBody 720). | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Physical activity, Behavioral intervention, Responders