AsthmaNCT05241223
An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma
A study testing Behavior change intervention and Educational program in people with Asthma and Sedentary Behavior, run by Universidade Norte do Paraná at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma, Sedentary Behavior, Physical Inactivity
- What is being tested?
- Behavior change intervention and Educational program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Feb 2022to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa e Pós Graduação na Unopar
Londrina, Paraná, 86041-14
About this study
Official title: An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma: a Randomized Controlled Trial
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.
- Conditions
- Asthma, Sedentary Behavior, Physical Inactivity
- Being tested
- Behavior change intervention, Educational program
- Medical subject headings
- Asthma, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior change interventionOther
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.
Educational programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | This group will receive an education program which will cover information regarding asthma, physical activity and sedentary behavior. Receives: Other: Educational program |
| Experimental group | Experimental | 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. Receives: Other: Behavior change intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from randomization
Number of steps per day
Number of steps per day measured by a triaxial activity monitor
Measured: 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.
Measured: 12 weeks from randomization
Secondary outcomes (29)
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.
Measured: 36 weeks from randomization
Number of steps per day
Number of steps per day measured by a triaxial activity monitor.
Measured: 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.
Measured: 36 weeks from randomization
Asthma control
Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Measured: 12 weeks from randomization
Asthma control
Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Measured: 36 weeks from randomization
Asthma symptoms and exacerbations
Frequency of asthma symptoms and exacerbations
Measured: 12 weeks from randomization
Asthma symptoms and exacerbations
Frequency of asthma symptoms and exacerbations
Measured: 36 weeks from randomization
Asthma medication use
Frequency of asthma rescue medication use
Measured: 12 weeks from randomization
Asthma medication use
Frequency of asthma rescue medication use
Measured: 36 weeks from randomization
Incremental Step Test
Number of steps climbed; the more the better
Measured: 12 weeks from randomization
Incremental Step Test
Number of steps climbed; the more the better
Measured: 36 weeks from randomization
Sit-To-Stand test
Number of repetitions in 1 minute; the more the better
Measured: 12 weeks from randomization
Sit-To-Stand test
Number of repetitions in 1 minute; the more the better
Measured: 36 weeks from randomization
Timed Up-and-Go test
Time to perform the test; the faster the better
Measured: 12 weeks from randomization
Timed Up-and-Go test
Time to perform the test; the faster the better
Measured: 36 weeks from randomization
4-Metre Gait Speed test
Time to perform the test; the faster the better
Measured: 12 weeks from randomization
4-Metre Gait Speed test
Time to perform the test; the faster the better
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 36 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start3 Feb 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karina Furlanetto, Universidade Norte do Paraná
- Investigators
- Joice Oliveira, Msc, Principal investigator, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241223
- Sponsor's protocol ID
- OliveiraJM_PhD_FurlanettoKC
- Status last verified
- Dec 2023
- First submitted
- 22 Jan 2022
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Oliveira JM, Pedroso A, de Melo DIF, Cunha MCA, de Lima FF, Carvalho CRF, Karloh M, Matias TS, Furlanetto KC. Short and medium term efficacy of an online behaviour change intervention on physical activity in adults with asthma. Sci Rep. 2026 Jan 8;16(1):4272. doi: 10.1038/s41598-025-34470-w.
PubMed 41501383de Oliveira JM, Karloh M, Matias TS, Barbosa GB, Freitas PD, Carvalho CRF, Furlanetto KC. An online behavior change intervention to promote physical activity in adults with asthma: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 7;23(1):983. doi: 10.1186/s13063-022-06881-x.
PubMed 36476386
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05241223
- Acronym / sponsor ID
- OliveiraJM_PhD_FurlanettoKC
- Conditions
- Asthma, Sedentary Behavior, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Educational programThis group will receive an education program which will cover information regarding asthma, physical activity and sedentary behavior. |
| Experimental group | Experimental | Other: Behavior change interventionIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior change interventionThis 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. | Other | Experimental group |
| Educational programThe 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. | Other | Control group |
Primary outcome
Time spent in physical activity
Time frame: 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.
Number of steps per day
Time frame: 12 weeks from randomization
Number of steps per day measured by a triaxial activity monitor
Time spent in sedentary behavior
Time frame: 12 weeks from randomization
Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
29 secondary outcomes
Time spent in physical activity
Time frame: 36 weeks from randomization
Number of steps per day
Time frame: 36 weeks from randomization
Time spent in sedentary behavior
Time frame: 36 weeks from randomization
Asthma control
Time frame: 12 weeks from randomization
Asthma control
Time frame: 36 weeks from randomization
Asthma symptoms and exacerbations
Time frame: 12 weeks from randomization
Asthma symptoms and exacerbations
Time frame: 36 weeks from randomization
Asthma medication use
Time frame: 12 weeks from randomization
Asthma medication use
Time frame: 36 weeks from randomization
Incremental Step Test
Time frame: 12 weeks from randomization
Incremental Step Test
Time frame: 36 weeks from randomization
Sit-To-Stand test
Time frame: 12 weeks from randomization
Sit-To-Stand test
Time frame: 36 weeks from randomization
Timed Up-and-Go test
Time frame: 12 weeks from randomization
Timed Up-and-Go test
Time frame: 36 weeks from randomization
4-Metre Gait Speed test
Time frame: 12 weeks from randomization
4-Metre Gait Speed test
Time frame: 36 weeks from randomization
Quality of life score
Time frame: 12 weeks from randomization
Quality of life score
Time frame: 36 weeks from randomization
Sleep quality
Time frame: 12 weeks from randomization
Sleep quality
Time frame: 36 weeks from randomization
Anxiety and depression symptoms
Time frame: 12 weeks from randomization
Anxiety and depression symptoms
Time frame: 36 weeks from randomization
Basic psychological needs
Time frame: 12 weeks from randomization
Basic psychological needs
Time frame: 36 weeks from randomization
Motivational regulations
Time frame: 12 weeks from randomization
Motivational regulations
Time frame: 36 weeks from randomization
Lung function
Time frame: 12 weeks from randomization
Lung function
Time frame: 36 weeks from randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 41501383de Oliveira JM, Pedroso A, de Melo DIF, Cunha MCA, de Lima FF, Carvalho CRF, Karloh M, Matias TS, Furlanetto KC. Short and medium term efficacy of an online behaviour change intervention on physical activity in adults with asthma. Sci Rep. 2026 Jan 8;16(1):4272. doi: 10.1038/s41598-025-34470-w.
- Derived from this study: PubMed 36476386de Oliveira JM, Karloh M, Matias TS, Barbosa GB, Freitas PD, Carvalho CRF, Furlanetto KC. An online behavior change intervention to promote physical activity in adults with asthma: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 7;23(1):983. doi: 10.1186/s13063-022-06881-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joice Oliveira, Msc principal investigator
Universidade Norte do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior change intervention and Educational program in people with Asthma and Sedentary Behavior, run by Universidade Norte do Paraná at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in physical activity (time frame: 12 weeks from randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241223, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.