EFFECTIVENESS OF AN EARLY BEHAVIORAL CHANGE STRATEGY AFTER ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE ON CARDIOVASCULAR PROFILE, PHYSICAL ACTIVITY LEVEL AND FUNCTIONALITY: RANDOMIZED CLINICAL TRIAL WITH FOLLOW-UP

• Grant number: 22/02397-4
• Support Opportunities: Scholarships in Brazil - Doctorate
• Effective date (Start): January 01, 2023
• Effective date (End): September 30, 2025
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Renata Gonçalves Mendes
• Grantee: Débora Mayumi de Oliveira Kawakami
• Host Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil

Abstract

Introduction: Chronic obstructive pulmonary disease (COPD) is a disease that affects people around the world and is characterized by chronic inflammation of the airways and represents 1 of the 3 most common causes of death in the world. The disease is marked by periods of stability and exacerbation with a negative impact on respiratory symptoms, functional capacity and risks of cardiovascular events, which are not always followed by insertion in Pulmonary Rehabilitation Programs (PR). Thus, due to the characteristic of the chronicity of the disease, the need for continued care and self-management, in addition to the barriers to PR, it is necessary to study the effectiveness of an approach based on few financial resources to support patient self-management. Objective: To evaluate the effectiveness of an intervention based on behavioral change for self-management of the disease after hospital discharge in patients with COPD on the cardiovascular profile, level of physical activity (PA) and functionality, as well as to analyze the maintenance of possible benefits (PA level and self-efficacy) 6 months after completion of the experimental protocol. Methodology: Randomized controlled clinical trial with a 6-month follow-up, parallel with 2 groups, single-blind. Randomization by blocks will occur through the website (randomizer.org) and the allocation of participants will be carried out using brown envelopes in the control group (CG) and intervention group (IG). Fifty-six patients with COPD exacerbation will be evaluated, admitted to hospital wards and followed up for 13 weeks after hospital discharge. Patients will be evaluated for cognitive status (Mini Mental State Examination); cardiovascular: cardiac autonomic modulation, vascular reactivity and arterial stiffness; Functional: 6-minute walk test. On the same day, they will receive an information diary and an ActivPALM3® accelerometer to assess the patient's PA level. After 7 days of hospital discharge, patients will be asked to answer the COPD Assessment Test", Medical Research Council, EuroQol, Duke Activity Status Index, Self-Efficacy Index adapted for Respiratory Rehabilitation and Handgrip Strength Assessment. Participants allocated to the CG will receive a printed booklet and participants allocated to the IG will receive a motivational interview, both with information and recommendations on COPD. In addition, both groups will receive a Fitbit Flex® activity monitor to use during the experimental protocol, however, only the IG will be motivated to increase e15% in the number of steps weekly. Participants will be reassessed at week 4 (full lung function test entry) and week 12 after starting the protocol. After this period, the participants will not be monitored, but will be invited to carry out a new evaluation in the 6th month after the end of the experimental protocol. The evaluations will consist of the application of PRAISE and the use of the ActivPALM3® accelerometer. Participants will be characterized in status: deteriorated, improved and unchanged according to the number of daily steps, PRAISE score and occurrence of COPD exacerbation in the period. Physiotherapists responsible for assessments and analysis of outcome variables will be blinded to patient allocation. Statistical analyzes will be processed in SPSS Statistics 25.0 IBM® software, with a significance level of 5%. Expected result: It is expected that the result of this study can bring a new low-cost strategy in the management of COPD in the transition between the period of exacerbation and stability of the disease, since in this period the patient is more vulnerable and receptive to changes in the habits. Hypothesis: It is hypothesized that patients undergoing intervention based on behavioral change have a better cardiovascular profile, increase in PA level and functionality, and remain physically active after 6 months of intervention.