Effects of aerobic training versus behavioral intervention to increase physical activity in patients with Asthma: a randomized, blinded clinical trial

• Grant number: 21/03745-3
• Support Opportunities: Scholarships in Brazil - Doctorate
• Effective date (Start): March 01, 2022
• Effective date (End): August 31, 2025
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Celso Ricardo Fernandes de Carvalho
• Grantee: David Halen Araújo Pinheiro
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated research grant: 18/17788-3 - Pulmonary rehabilitation: effect of new patient-centered methodologies and technologies in patients with chronic pulmonary diseases, AP.TEM

Abstract

Regular physical exercise and behavioural intervention to increase physical activity provide numerous benefits to patients with Asthma. However, the comparison of the effects of these interventions on the clinical control of the disease is unknown in the literature. Objectives: The aims of the present study are: I) 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; II) evaluate the impact of these interventions on the quality of sleep and on the psychological disorders of these patients; III) analyse the effects of these interventions on exacerbations and barriers that hinder the practice of PADL (physical activity in daily life) for patients with Asthma; IV) evaluate the effects of the interventions in the medium term. Methods: This is a randomized, two-armed clinical trial with blind evaluation. The sample population will consist of 56 adult patients with physically inactive Asthma and uncontrolled Asthma. Eligible patients will be randomized to the aerobic training (GTA) or behavioural intervention (GIC) groups. The interventions will have a total of 16 interventions for each group. The aerobic training will be performed on a treadmill for 8 weeks (2x without; 45 min/session) and the intensity monitored by the maximum heart rate established in the cardiopulmonary stress test. The behavioural intervention will be based on the social cognitive theory and the behaviour change stages will last for 8 weeks (1 x week; 90 min/session). The total duration of each program will be 12 hours. Pre- and post-intervention assessments will include Clinical Asthma Control (CAQ) and health factors related to Quality of Life in Asthma (QLA). The level of PADL (accelerometry), body composition, Level of Daily Physical Activity (LDPA) and Symptoms of Anxiety and Depression (SADs) will also be assessed. The sample number was calculated to be 56 patients. Time and group interactions will be evaluated using analysis of variance of repeated two-way measurements. The two way analysis of variance (ANOVA two way) will be used to compare groups and the level of significance will be adjusted to 5% (p <0.05). (AU)