Clinical trial NCT05241223: An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma
Official title: An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Sedentary Behavior
Physical Inactivity
Lead sponsor: Universidade Norte do Paraná
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time spent in physical activity
timeFrame: 12 weeks from randomization
measure: Number of steps per day
timeFrame: 12 weeks from randomization
measure: Time spent in sedentary behavior
timeFrame: 12 weeks from randomization
Secondary outcomes:
measure: Time spent in physical activity
timeFrame: 36 weeks from randomization
measure: Number of steps per day
timeFrame: 36 weeks from randomization
measure: Time spent in sedentary behavior
timeFrame: 36 weeks from randomization
measure: Asthma control
timeFrame: 12 weeks from randomization
measure: Asthma control
timeFrame: 36 weeks from randomization
measure: Asthma symptoms and exacerbations
timeFrame: 12 weeks from randomization
measure: Asthma symptoms and exacerbations
timeFrame: 36 weeks from randomization
measure: Asthma medication use
timeFrame: 12 weeks from randomization
measure: Asthma medication use
timeFrame: 36 weeks from randomization
measure: Incremental Step Test
timeFrame: 12 weeks from randomization
measure: Incremental Step Test
timeFrame: 36 weeks from randomization
measure: Sit-To-Stand test
timeFrame: 12 weeks from randomization
measure: Sit-To-Stand test
timeFrame: 36 weeks from randomization
measure: Timed Up-and-Go test
timeFrame: 12 weeks from randomization
measure: Timed Up-and-Go test
timeFrame: 36 weeks from randomization
measure: 4-Metre Gait Speed test
timeFrame: 12 weeks from randomization
measure: 4-Metre Gait Speed test
timeFrame: 36 weeks from randomization
measure: Quality of life score
timeFrame: 12 weeks from randomization
measure: Quality of life score
timeFrame: 36 weeks from randomization
measure: Sleep quality
timeFrame: 12 weeks from randomization
measure: Sleep quality
timeFrame: 36 weeks from randomization
measure: Anxiety and depression symptoms
timeFrame: 12 weeks from randomization
measure: Anxiety and depression symptoms
timeFrame: 36 weeks from randomization
measure: Basic psychological needs
timeFrame: 12 weeks from randomization
measure: Basic psychological needs
timeFrame: 36 weeks from randomization
measure: Motivational regulations
timeFrame: 12 weeks from randomization
measure: Motivational regulations
timeFrame: 36 weeks from randomization
measure: Lung function
timeFrame: 12 weeks from randomization
measure: Lung function
timeFrame: 36 weeks from randomization
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Centro de Pesquisa e Pós Graduação na Unopar
state: Paraná
Study officials:
affiliation: Universidade Norte do Paraná
name: Joice Oliveira, Msc
role: PRINCIPAL_INVESTIGATOR
References: