Asthma
Conditions
Keywords
Asthma, Physical activity, Behavioral intervention, Responders
Brief 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.
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).
Interventions
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.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.
Intervention model description
Longitudinal intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Participants not physically active; 2. Partially/uncontrolled asthma; 3. Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020); 4. Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital; 5. Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least , 30 days; 6. Being using optimized drug therapy for asthma.
Exclusion criteria
1. Participation in another research protocol; 2. Difficulty in understanding any of the questionnaires used; 3. Practitioners of regular physical activity; 4. Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity levels | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Factors Related to Quality of Life in Asthma | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 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 in body composition - Weight | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | Bioimpedance (Octopolar InBody 720). |
| Change in body composition - Fat mass | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | Bioimpedance (Octopolar InBody 720). |
| Change in body composition - Visceral adiposity area | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | Bioimpedance (Octopolar InBody 720). , Fat-free mass, and skeletal muscle mass will be calculated. |
| Change in body composition - Fat-free mass | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | Bioimpedance (Octopolar InBody 720). |
| Change in body composition - Skeletal muscle mass | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | Bioimpedance (Octopolar InBody 720). |
| Change in sedentary behaviour | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 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 in asthma clinical control | 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. |
| Change in psychosocial symptoms | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioral Stage for physical activity practice | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 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. |
| Pulmonary function | Baseline | Lung volumes will be assessed by spirometry |
| Change in anthropometric indexes | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR) |
| Changes in Barriers to the practice of Physical Activities of Daily Living | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 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. |
| Change in asthma exacerbation | Change from baseline at 8 weeks of intervention and at 16 weeks post intervention | 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 |
Countries
Brazil
Outcome results
None listed