An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma
- Conditions
- Sedentary BehaviorAsthmaPhysical Inactivity
- Interventions
- Other: Educational programOther: Behavior change intervention
- Registration Number
- NCT05241223
- Lead Sponsor
- Universidade Norte do Paraná
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Educational program This group will receive an education program which will cover information regarding asthma, physical activity and sedentary behavior. Experimental group Behavior change intervention 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.
- Primary Outcome Measures
Name Time Method Time spent in physical activity 12 weeks from randomization 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 spent in sedentary behavior 12 weeks from randomization Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
Number of steps per day 12 weeks from randomization Number of steps per day measured by a triaxial activity monitor
- Secondary Outcome Measures
Name Time Method Asthma symptoms and exacerbations 36 weeks from randomization Frequency of asthma symptoms and exacerbations
Asthma medication use 36 weeks from randomization Frequency of asthma rescue medication use
Time spent in sedentary behavior 36 weeks from randomization Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
Sit-To-Stand test 36 weeks from randomization Number of repetitions in 1 minute; the more the better
Time spent in physical activity 36 weeks from randomization Time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.
Asthma control 36 weeks from randomization Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Quality of life score 36 weeks from randomization Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life
Number of steps per day 36 weeks from randomization Number of steps per day measured by a triaxial activity monitor.
4-Metre Gait Speed test 36 weeks from randomization Time to perform the test; the faster the better
Motivational regulations 36 weeks from randomization Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level
Incremental Step Test 36 weeks from randomization Number of steps climbed; the more the better
Timed Up-and-Go test 36 weeks from randomization Time to perform the test; the faster the better
Sleep quality 36 weeks from randomization 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).
Basic psychological needs 36 weeks from randomization Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs
Anxiety and depression symptoms 36 weeks from randomization Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms
Lung function 36 weeks from randomization Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.
Trial Locations
- Locations (1)
Centro de Pesquisa e Pós Graduação na Unopar
🇧🇷Londrina, Paraná, Brazil