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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention to Increase Physical Activity | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Barriers to the practice of Physical Activities of Daily Living | The possible answers to the questionnaire Barriers to the practice of Physical Activities of Daily Living are never, rarely, sometimes, almost always or always and the score for each item varies from 0 to 4. It will be considered as limiting domain for physical activities those in which individuals report a value equal to or greater than 3 in at least half of the barriers. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Celso RF Carvalho, PhD | University of Sao Paulo General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital of São Paulo University medical school (HCFMUSP) | São Paulo | São Paulo | 05360-160 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37651174 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Longitudinal intervention study
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Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.
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| 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. | 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. | 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. | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| Change in body composition - Weight | Bioimpedance (Octopolar InBody 720). | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| Change in body composition - Fat mass | Bioimpedance (Octopolar InBody 720). | 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. | 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). | 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). | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| Change in asthma exacerbation | Asthma exacerbation will be assessed by the following criteria: the use of ≥4 puffs of rescue medication per 24 hours during a 48-hour period, a need for systemic corticosteroids, an unscheduled medical appointment, and either a visit to an emergency room or hospitalization | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| Change in Behavioral Stage for physical activity practice | The Behavioral Stage Assessment Questionnaire for the Practice of Physical Activity qualitatively assesses thinking in relation to the practice of physical activity, and may present the following stages of behavior: 1. Pre-contemplation; 2. Contemplation; 3. Preparation; 4. Action; 5- Maintenance. | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| Pulmonary function | Lung volumes will be assessed by spirometry | Baseline |
| Change in anthropometric indexes | Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR) | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |