Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial

Frontiers in Medicine

Medicine

Pablo Martinez-Amezcua¹  Luiz Fernando Rodrigues Junior²  Alejandro M. Hasslocher-Moreno³  Leonardo G. Ribeiro³  Roberto M. Saraiva³  Andrea S. Sousa³  Henrique H. Veloso³  Luiz Henrique C. Sangenis³  Marcelo T. Holanda³  Paula S. Silva³  Fernanda S. N. S. Mendes³  Flavia Mazzoli-Rocha³  Rudson S. Silva³  Isis G. G. Xavier³  Gilberto M. Sperandio Da Silva³  Fernanda M. Carneiro³  Andrea R. Costa³  Marcelo C. Vieira⁴  Mauro F. F. Mediano⁵  Livia C. Liporagi-Lopes⁶  Michel S. Reis⁷  Tatiana R. Gonçalves⁸  Juliana P. Borges⁹  Vitor B. Paravidino^1,10  Henrique S. Costa^1,11 

[1] Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States;Department of Research and Education, National Institute of Cardiology, Rio de Janeiro, RJ, Brazil;Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil;Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil;Center for Cardiology and Exercise, Aloysio de Castro State Institute of Cardiology, Rio de Janeiro, RJ, Brazil;Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil;Department of Research and Education, National Institute of Cardiology, Rio de Janeiro, RJ, Brazil;Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil;Faculty of Physical Therapy, School of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil;Institute of Collective Health, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil;Institute of Physical Education and Sports, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil;Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil;Department of Physical Education and Sports, Naval Academy – Brazilian Navy, Rio de Janeiro, RJ, Brazil;Physical Therapy Department, Federal University of Jequitinhonha and Mucuri Valleys, Diamantina, MG, Brazil;

关键词: physical activity;    exercise training;    mental health;    fitness;    Chagas disease;    quality of life;   

DOI  :  10.3389/fmed.2022.1087188

 received in 2022-11-02, accepted in 2022-12-13,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundChagas disease (CD) is a neglected endemic disease with worldwide impact due to migration. Approximately 50–70% of individuals in the chronic phase of CD present the indeterminate form, characterized by parasitological and/or serological evidence of Trypanosoma cruzi infection, but without clinical signs and symptoms. Subclinical abnormalities have been reported in indeterminate form of CD, including pro-inflammatory states and alterations in cardiac function, biomarkers and autonomic modulation. Moreover, individuals with CD are usually impacted on their personal and professional life, making social insertion difficult and impacting their mental health and quality of life (QoL). Physical exercise has been acknowledged as an important strategy to prevent and control numerous chronic-degenerative diseases, but unexplored in individuals with the indeterminate form of CD. The PEDI-CHAGAS study (which stands for “Home-Based Exercise Program in the Indeterminate Form of Chagas Disease” in Portuguese) aims to evaluate the effects of a home-based exercise program on physical and mental health outcomes in individuals with indeterminate form of CD.Methods and designThe PEDI-CHAGAS is a two-arm (exercise and control) phase 3 superiority randomized clinical trial including patients with indeterminate form of CD. The exclusion criteria are <18 years old, evidence of non-Chagasic cardiomyopathy, musculoskeletal or cognitive limitations that preclude the realization of exercise protocol, clinical contraindication for regular exercise, and regular physical exercise (≥1 × per week). Participants will be assessed at baseline, and after three and 6 months of follow-up. The primary outcome will be QoL. Secondary outcomes will include blood pressure, physical fitness components, nutritional status, fatigability, autonomic modulation, cardiac morphology and function, low back pain, depression and anxiety, stress, sleep quality, medication use and adherence, and biochemical, inflammatory and cardiac biomarkers. Participants in the intervention group will undergo a home-based exercise program whilst those in the control group will receive only general information regarding the benefits of physical activity. Both groups will receive the same general nutritional counseling consisting of general orientations about healthy diets.ConclusionThe findings from the present study may support public health intervention strategies to improve physical and mental health parameters to be implemented more effectively in this population.Clinical trial registration[https://ensaiosclinicos.gov.br/rg/RBR-10yxgcr9/], identifier [U1111-1263-0153].

【 授权许可】

Unknown   
Copyright © 2023 Mediano, Ribeiro, Silva, Xavier, Vieira, Gonçalves, Paravidino, Borges, Rodrigues Junior, Costa, Reis, Liporagi-Lopes, Martinez-Amezcua, Silva, Sperandio Da Silva, Sousa, Holanda, Veloso, Carneiro, Mazzoli-Rocha, Costa, Saraiva, Mendes, Sangenis and Hasslocher-Moreno.