AsthmaNCT05364632
Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma
A study testing Behavioral Intervention to Increase Physical Activity and Aerobic Training in people with Asthma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
To compare the effects of aerobic training and behavioural intervention to increase physical activity in the clinical control of asthma and in the quality of life of patients with asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Behavioral Intervention to Increase Physical Activity and Aerobic Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Aug 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants not physically active;
- Uncontrolled asthma (ACQ>1,5);
- Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);
- Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;
- Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least 30 days;
- Being using optimized drug therapy for asthma.
Who cannot join
- Participation in another research protocol;
- Difficulty in understanding any of the questionnaires used;
- Practitioners of regular physical activity;
- Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol;
- Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;
- Patients who are smokers or ex-smokers (who have quit smoking for less than 1 year or who have smoked more than 15 pack-years).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Clinical Hospital of São Paulo University medical school (HCFMUSP)
São Paulo, São Paulo, 05360-160
Celso RF Carvalho, PhD, cscarval@usp.br
About this study
Official title: Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma: a Randomized, Blinded Clinical Trial.
To compare the effects of aerobic training and behavioural intervention to increase physical activity in the clinical control of asthma and in the quality of life of patients with asthma.
Read the detailed description
Adult participants of both genders with moderate to severe asthma, not physically active, will be evaluated after being informed about the study, agreeing and signing the informed consent form. Participants will be randomized to aerobic training or behavioral intervention group. Both interventions will consist of 8 weeks. Aerobic training will be performed on a treadmill (2xweek; 45 min/session). The behavioral intervention will be a program to increase physical activity (1xweek; up to 90 min / session). The maximum HR will be estimated according to the Tanaka's equation (208 - 0.7 x age).
- Conditions
- Asthma
- Being tested
- Behavioral Intervention to Increase Physical Activity, Aerobic Training
- Keywords
- asthma, physical activity, physical exercise, quality of life
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention to Increase Physical ActivityBehavioural
The educational program will consist of 2 classes held once a week, each lasting 90 minutes. The classes will be based on an education videotape, presentations and group discussions. The first class will address the asthma education. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active. The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting until 90 minutes. Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation. According to their own physical activity (PA) data and the behavioural change stage, an individual action plan will be established to increase physical activity. Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time.
Aerobic TrainingOther
The same initial educational program described for the Behavioral Intervention group will be delivered to this group. Each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down. During physical training, heart rate and level of respiratory distress will be monitored. The intensity of aerobic physical training will be based on the heart rate (HR) corresponding to one third of the difference between the anaerobic threshold (LA) and the respiratory compensation point (CRP). The patient may interrupt physical exercise if he presents any clinical symptoms and/or respiratory discomfort, returning as soon as his respiratory condition improves.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Experimental | Participants will undergo an eight-week behavioral intervention protocol (once a week) aimed at increasing the level of physical activity, consisting of a brief educational program: brief education for asthma and benefits of physical activity and behavioral intervention based on Social Cognitive Theory and the Theory of Stages of Behavior Change. Receives: Behavioral: Behavioral Intervention to Increase Physical Activity |
| Aerobic Training | Experimental | Participants will undergo an eight-week aerobic training protocol (twice a week) on a treadmill, each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down. Receives: Other: Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma clinical control
Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ). The ACQ contains 7 items rated on a 7- point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control. Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.
Measured: [Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Secondary outcomes (9)
Change in sedentary behaviour
Sedentary behaviour will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt. Sedentary behaviour will be quantify by the time spent sedentary (<100 counts/min).
Measured: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in physical activity levels
Physical activity will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.
Measured: [Time Frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Change in Health Factors Related to Quality of Life in Asthma
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ). The AQLQ consists of 32 items rated on a 7-point scale (1 = great deal, 7 = not at all) divided into the following 4 domains: activity limitations, symptoms, emotional function and environmental stimuli. Higher AQLQ scores indicate a better quality of life, and treatments resulting in a 0.5-point increase in scores following an intervention are considered to be clinically effective.
Measured: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in psychosocial symptoms
Symptoms of anxiety and depression symptoms will be assessed by the Hospital Anxiety and Depression scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression). Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale. A score greater than 8/9 in each subscale suggests a diagnosis of either anxiety and/or depression.
Measured: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Weight
Bioimpedance (Octopolar InBody 720).
Measured: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Fat mass
Bioimpedance (Octopolar InBody 720).
Measured: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Visceral adiposity area
Bioimpedance (Octopolar InBody 720). ,Fat-free mass, and skeletal muscle mass will be calculated.
Measured: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention.
Change in body composition - Fat-free mass
Bioimpedance (Octopolar InBody 720).
Measured: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Change in body composition - Skeletal muscle mass
muscle mass Bioimpedance (Octopolar InBody 720).
Measured: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start23 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Celso R. Carvalho, University of Sao Paulo General Hospital
- Investigators
- Celso RF Carvalho, PhD, Study director, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364632
- Sponsor's protocol ID
- 2021/03745-3
- Status last verified
- May 2025
- First submitted
- 3 May 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Araujo Pinheiro DH, Silva RAD, Lunardi AC, Cervera VZ, Carvalho-Pinto RM, de Lima FF, Carvalho CRF. Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity for Disease Control in Patients With Asthma: Protocol for a Randomized Trial. JMIR Res Protoc. 2025 Oct 30;14:e78603. doi: 10.2196/78603.
PubMed 41166708
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma: a Randomized, Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT05364632
- Acronym / sponsor ID
- 2021/03745-3
- Conditions
- Asthma
- Keywords
- asthma, physical activity, physical exercise, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 May 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.
To compare the effects of aerobic training and behavioural intervention to increase physical activity in the clinical control of asthma and in the quality of life of patients with asthma.
Detailed description
Adult participants of both genders with moderate to severe asthma, not physically active, will be evaluated after being informed about the study, agreeing and signing the informed consent form. Participants will be randomized to aerobic training or behavioral intervention group. Both interventions will consist of 8 weeks. Aerobic training will be performed on a treadmill (2xweek; 45 min/session). The behavioral intervention will be a program to increase physical activity (1xweek; up to 90 min / session). The maximum HR will be estimated according to the Tanaka's equation (208 - 0.7 x age).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral: Behavioral Intervention to Increase Physical ActivityParticipants will undergo an eight-week behavioral intervention protocol (once a week) aimed at increasing the level of physical activity, consisting of a brief educational program: brief education for asthma and benefits of physical activity and behavioral intervention based on Social Cognitive Theory and the Theory of Stages of Behavior Change. |
| Aerobic Training | Experimental | Other: Aerobic TrainingParticipants will undergo an eight-week aerobic training protocol (twice a week) on a treadmill, each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants not physically active;
- Uncontrolled asthma (ACQ>1,5);
- Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);
- Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;
- Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least 30 days;
Key exclusion criteria (6 listed)
- Participation in another research protocol;
- Difficulty in understanding any of the questionnaires used;
- Practitioners of regular physical activity;
- Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol;
- Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;
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 |
|---|---|---|
| Behavioral Intervention to Increase Physical ActivityThe educational program will consist of 2 classes held once a week, each lasting 90 minutes. The classes will be based on an education videotape, presentations and group discussions. The first class will address the asthma education. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active. The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting until 90 minutes. Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation. According to their own physical activity (PA) data and the behavioural change stage, an individual action plan will be established to increase physical activity. Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time. | Behavioural | Behavioral Intervention |
| Aerobic TrainingThe same initial educational program described for the Behavioral Intervention group will be delivered to this group. Each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down. During physical training, heart rate and level of respiratory distress will be monitored. The intensity of aerobic physical training will be based on the heart rate (HR) corresponding to one third of the difference between the anaerobic threshold (LA) and the respiratory compensation point (CRP). The patient may interrupt physical exercise if he presents any clinical symptoms and/or respiratory discomfort, returning as soon as his respiratory condition improves. | Other | Aerobic Training |
Primary outcome
Change in asthma clinical control
Time frame: [Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ). The ACQ contains 7 items rated on a 7- point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control. Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.
9 secondary outcomes
Change in sedentary behaviour
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in physical activity levels
Time frame: [Time Frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Change in Health Factors Related to Quality of Life in Asthma
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in psychosocial symptoms
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Weight
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Fat mass
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Visceral adiposity area
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention.
Change in body composition - Fat-free mass
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Change in body composition - Skeletal muscle mass
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 41166708Araujo Pinheiro DH, Silva RAD, Lunardi AC, Cervera VZ, Carvalho-Pinto RM, de Lima FF, Carvalho CRF. Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity for Disease Control in Patients With Asthma: Protocol for a Randomized Trial. JMIR Res Protoc. 2025 Oct 30;14:e78603. doi: 10.2196/78603.
- 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.
Celso RF Carvalho, PhD study director
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention to Increase Physical Activity and Aerobic Training in people with Asthma, run by University of Sao Paulo General Hospital 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celso RF Carvalho, PhD (55 11 98415-3234, cscarval@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in asthma clinical control (time frame: [Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]). 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 NCT05364632, which also lists 1 linked publication.
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 15 May 2025.