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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
51
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.
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.
Centro de Pesquisa e Pós Graduação na Unopar
Londrina, Paraná, Brazil
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.
Time frame: 12 weeks from randomization
Number of steps per day
Number of steps per day measured by a triaxial activity monitor
Time frame: 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.
Time frame: 12 weeks from randomization
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.
Time frame: 36 weeks from randomization
Number of steps per day
Number of steps per day measured by a triaxial activity monitor.
Time frame: 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.
Time frame: 36 weeks from randomization
Asthma control
Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Time frame: 12 weeks from randomization
Asthma control
Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Time frame: 36 weeks from randomization
Asthma symptoms and exacerbations
Frequency of asthma symptoms and exacerbations
Time frame: 12 weeks from randomization
Asthma symptoms and exacerbations
Frequency of asthma symptoms and exacerbations
Time frame: 36 weeks from randomization
Asthma medication use
Frequency of asthma rescue medication use
Time frame: 12 weeks from randomization
Asthma medication use
Frequency of asthma rescue medication use
Time frame: 36 weeks from randomization
Incremental Step Test
Number of steps climbed; the more the better
Time frame: 12 weeks from randomization
Incremental Step Test
Number of steps climbed; the more the better
Time frame: 36 weeks from randomization
Sit-To-Stand test
Number of repetitions in 1 minute; the more the better
Time frame: 12 weeks from randomization
Sit-To-Stand test
Number of repetitions in 1 minute; the more the better
Time frame: 36 weeks from randomization
Timed Up-and-Go test
Time to perform the test; the faster the better
Time frame: 12 weeks from randomization
Timed Up-and-Go test
Time to perform the test; the faster the better
Time frame: 36 weeks from randomization
4-Metre Gait Speed test
Time to perform the test; the faster the better
Time frame: 12 weeks from randomization
4-Metre Gait Speed test
Time to perform the test; the faster the better
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 36 weeks from randomization
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