AsthmaNCT05159076
Behavioral Intervention to Increase Physical Activity in Patients with Asthma: Identifying Responders
A study testing Behavioral Intervention to Increase Physical Activity in people with Asthma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
To identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2022to 13 Nov 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants not physically active;
- Partially/uncontrolled asthma;
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of São Paulo University medical school (HCFMUSP)
São Paulo, São Paulo, 05360-160
About this study
Official title: Behavioral Intervention to Increase Physical Activity in Patients with Asthma: Identifying the Profile of Responders
To identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity.
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. After two days of evaluations, with an interval of 7 days between them, the participants will be included in a behavioral intervention program to increase physical activity for 8 weeks (once a week).
- Conditions
- Asthma
- Being tested
- Behavioral Intervention to Increase Physical Activity
- Keywords
- Asthma, Physical activity, Behavioral intervention, Responders
- 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.
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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 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
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
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 posted15 Dec 2021
- Study start2 May 2022
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal intervention study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, 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
- NCT05159076
- Sponsor's protocol ID
- BIPAPA
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Lima FF, Lunardi AC, Pinheiro DHA, Carvalho-Pinto RM, Stelmach R, Giavina-Bianchi P, Agondi RC, Carvalho CR. Identifying the Characteristics of Responders and Nonresponders in a Behavioral Intervention to Increase Physical Activity Among Patients With Moderate to Severe Asthma: Protocol for a Prospective Pragmatic Study. JMIR Res Protoc. 2023 Aug 31;12:e49032. doi: 10.2196/49032.
PubMed 37651174
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention to Increase Physical Activity in Patients with Asthma: Identifying the Profile of Responders
- ClinicalTrials.gov ID
- NCT05159076
- Acronym / sponsor ID
- BIPAPA
- Conditions
- Asthma
- Keywords
- Asthma, Physical activity, Behavioral intervention, Responders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 2 May 2022 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 15 Dec 2021 (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 identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity.
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. After two days of evaluations, with an interval of 7 days between them, the participants will be included in a behavioral intervention program to increase physical activity for 8 weeks (once a week).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal intervention study
| 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. |
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;
- Partially/uncontrolled asthma;
- 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 (4 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.
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 |
Primary outcome
Change in physical activity levels
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Physical activity will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.
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 asthma clinical control
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
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 6 Dec 2024.
- Derived from this study: PubMed 37651174de Lima FF, Lunardi AC, Pinheiro DHA, Carvalho-Pinto RM, Stelmach R, Giavina-Bianchi P, Agondi RC, Carvalho CR. Identifying the Characteristics of Responders and Nonresponders in a Behavioral Intervention to Increase Physical Activity Among Patients With Moderate to Severe Asthma: Protocol for a Prospective Pragmatic Study. JMIR Res Protoc. 2023 Aug 31;12:e49032. doi: 10.2196/49032.
- 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.
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 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 4 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 6 Dec 2024. 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?
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?
Change in physical activity levels (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 NCT05159076, 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 6 Dec 2024.