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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
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.
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.
Clinical Hospital of São Paulo University medical school (HCFMUSP)
São Paulo, São Paulo, Brazil
RECRUITINGChange 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.
Time frame: [Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
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).
Time frame: 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.
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
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.
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
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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.
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Weight
Bioimpedance (Octopolar InBody 720).
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Fat mass
Bioimpedance (Octopolar InBody 720).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]