Behavioral Intervention to Increase Physical Activity in Patients with Asthma: Identifying Responders
- Conditions
- Asthma
- Interventions
- Behavioral: Behavioral Intervention to Increase Physical Activity
- Registration Number
- NCT05159076
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Behavioral Intervention Behavioral Intervention to Increase Physical Activity 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 - Fat-free mass Change from baseline at 8 weeks of intervention and at 16 weeks post intervention Bioimpedance (Octopolar InBody 720).
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.
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 - 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.
Trial Locations
- Locations (1)
Clinical Hospital of São Paulo University medical school (HCFMUSP)
🇧🇷São Paulo, Brazil