Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma
- Conditions
- Asthma
- Interventions
- Behavioral: Behavioral Intervention to Increase Physical ActivityOther: Aerobic Training
- Registration Number
- NCT05364632
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
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.
- 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. 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
- Participants not physically active;
- Uncontrolled asthma (ACQ>1,5);
- 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;
- Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;
- Patients who are smokers or ex-smokers (who have quit smoking for less than 1 year or who have smoked more than 15 pack-years).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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. Aerobic Training Aerobic Training Participants will undergo an eight-week aerobic training protocol (twice a week) on a treadmill, 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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 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 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] muscle mass Bioimpedance (Octopolar InBody 720).
Trial Locations
- Locations (1)
Clinical Hospital of São Paulo University medical school (HCFMUSP)
🇧🇷São Paulo, Brazil