An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma

Study Overview
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Brief Summary
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The aims of this study are to investigate the effectiveness of an online behavior change (BC) intervention in increasing physical activity (PA) and reducing sedentary behavior in adults with asthma, as well as, in improving other clinical outcomes, in short and medium term. In this single-blind randomized clinical trial, patients with clinically stable moderate to severe asthma, who are physically inactive and do not have cardiovascular and/or osteoneuromuscular impairments will be randomized into control (CG) or intervention (IG) groups (23 in each group). Both groups will carry out a minimum educational program. Additionally, the IG will receive weekly individual and/or group online sessions for 12 weeks of motivation-based BC intervention to promote PA and reduce sedentary behavior, based on both self-determination theory (SDT) and transtheoretical model (TTM). The IG will also receive a pedometer with specific strategies related to it. Both groups will be reassessed immediately after the intervention as well as 6 months after the end of the intervention. The primary outcomes are PA and sedentary behavior, which will be objectively assessed by a triaxial accelerometer (Actigraph wGT3X-BT). Secondary outcomes are: asthma control, functional capacity, quality of life, sleep quality and symptoms of anxiety and depression.

Official Title
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An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma: a Randomized Controlled Trial

Conditions
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Asthma, Sedentary Behavior, Physical Inactivity

Intervention / Treatment
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* Other: Behavior change intervention
* Other: Educational program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people aged from 18 to 60 years diagnosis of moderate to severe asthma, who underwent drug treatment for at least 6 months clinical stability for at least 1 month (without hospitalizations, emergency care use or medication changes) absence of cardiovascular and/or osteoneuromuscular diseases that could interfere/hinder the performance of tests and physical activity absence of lung diseases other than asthma preserved cognitive function non-smokers or ex-smokers with <10 pack-years report being physically inactive in accordance with current physical activity guidelines able to make video calls through any platform and/or free app available Exclusion Criteria: presence of any new orthopedic limitation that hinders the performance of physical activity during the study perform ≥150 minutes per week of moderate to vigorous physical activity during the initial assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>This group will receive an education program which will cover information regarding asthma, physical activity and sedentary behavior. | Other: Educational program<br>* The educational program will be delivered similarly to both groups through videos and booklets, which will be sent in all weekdays during de first week after the initial assessment. Later, one educational material will be sent every two weeks until de 11th week. In the first day, patients will receive a quick welcome video call, in which information will be provided on how this program will work. In the subsequent days, the material will be sent daily and the participants will be able to ask questions, if they want to. The program will cover information regarding the respiratory system, pathophysiology of asthma, asthma treatment, prevention strategies and medication instructions. It will also be briefly addressed the subjects: understanding physical activity and sedentarism, as well as the importance and benefits of being physically active and less sedentary.<br>|
| Experimental: Experimental group<br>In addition to the educational program, this group will receive weekly individual and/or group online sessions for 12 weeks of motivation-based on behavior change intervention to promote physical activity and reduce sedentary behavior, based on both self-determination theory and transtheoretical model. They will also receive a pedometer with specific strategies related to it. | Other: Behavior change intervention<br>* This is an online intervention based on the transtheoretical model, along with self-determination theory strategies. This intervention will take place weekly summing up 12 online individual and/or group sessions of approximately 20 minutes. The sessions will be made through a platform and/or application that makes video calls privately. Each session will address a topic. In addition, in all sessions, the patients gain during the previous week will be recognized, as well as new goals will be set for the next week. The goals will always be individualized, realistic and achievable, based on the identification of each person's capacity and motivation. A Fitbit Zip will be used to propose objective goals aimed at increasing physical activity and reduce sedentary behavior. Additionally, a complex practice environment will be created around this device, such as the visualization of the number of steps evolution and competitions/games with other participants, among others.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in physical activity | Time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor. | 12 weeks from randomization | 
| Number of steps per day | Number of steps per day measured by a triaxial activity monitor | 12 weeks from randomization | 
| Time spent in sedentary behavior | Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor. | 12 weeks from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in physical activity | Time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor. | 36 weeks from randomization | 
| Number of steps per day | Number of steps per day measured by a triaxial activity monitor. | 36 weeks from randomization | 
| Time spent in sedentary behavior | Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor. | 36 weeks from randomization | 
| Asthma control | Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better. | 12 weeks from randomization | 
| Asthma control | Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better. | 36 weeks from randomization | 
| Asthma symptoms and exacerbations | Frequency of asthma symptoms and exacerbations | 12 weeks from randomization | 
| Asthma symptoms and exacerbations | Frequency of asthma symptoms and exacerbations | 36 weeks from randomization | 
| Asthma medication use | Frequency of asthma rescue medication use | 12 weeks from randomization | 
| Asthma medication use | Frequency of asthma rescue medication use | 36 weeks from randomization | 
| Incremental Step Test | Number of steps climbed; the more the better | 12 weeks from randomization | 
| Incremental Step Test | Number of steps climbed; the more the better | 36 weeks from randomization | 
| Sit-To-Stand test | Number of repetitions in 1 minute; the more the better | 12 weeks from randomization | 
| Sit-To-Stand test | Number of repetitions in 1 minute; the more the better | 36 weeks from randomization | 
| Timed Up-and-Go test | Time to perform the test; the faster the better | 12 weeks from randomization | 
| Timed Up-and-Go test | Time to perform the test; the faster the better | 36 weeks from randomization | 
| 4-Metre Gait Speed test | Time to perform the test; the faster the better | 12 weeks from randomization | 
| 4-Metre Gait Speed test | Time to perform the test; the faster the better | 36 weeks from randomization | 
| Quality of life score | Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life | 12 weeks from randomization | 
| Quality of life score | Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life | 36 weeks from randomization | 
| Sleep quality | Subjectively measured by Pittsburgh Sleep Quality Index (score ranges from 0 to 21; the lower, the better) and objectively measured by Actiwatch 2 (Philips Respironics, Murrysville, Pennsylvania, USA). | 12 weeks from randomization | 
| Sleep quality | Subjectively measured by Pittsburgh Sleep Quality Index (score ranges from 0 to 21; the lower, the better) and objectively measured by Actiwatch 2 (Philips Respironics, Murrysville, Pennsylvania, USA). | 36 weeks from randomization | 
| Anxiety and depression symptoms | Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms | 12 weeks from randomization | 
| Anxiety and depression symptoms | Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms | 36 weeks from randomization | 
| Basic psychological needs | Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs | 12 weeks from randomization | 
| Basic psychological needs | Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs | 36 weeks from randomization | 
| Motivational regulations | Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level | 12 weeks from randomization | 
| Motivational regulations | Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level | 36 weeks from randomization | 
| Lung function | Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index. | 12 weeks from randomization | 
| Lung function | Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index. | 36 weeks from randomization |