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

被引:1
作者
Mediano, Mauro F. F. [1 ,2 ]
Ribeiro, Leonardo G. [1 ]
Silva, Rudson S. [1 ]
Xavier, Isis G. G. [1 ]
Vieira, Marcelo C. [1 ,3 ]
Goncalves, Tatiana R. [4 ]
Paravidino, Vitor B. [5 ,6 ]
Borges, Juliana P. [7 ]
Rodrigues Junior, Luiz Fernando [2 ]
Costa, Henrique S. [8 ]
Reis, Michel S. [9 ]
Liporagi-Lopes, Livia C. [10 ]
Martinez-Amezcua, Pablo [11 ]
Silva, Paula S. [1 ]
Sperandio Da Silva, Gilberto M. [1 ]
Sousa, Andrea S. [1 ]
Holanda, Marcelo T. [1 ]
Veloso, Henrique H. [1 ]
Carneiro, Fernanda M. [1 ]
Mazzoli-Rocha, Flavia [1 ]
Costa, Andrea R. [1 ]
Saraiva, Roberto M. [1 ]
Mendes, Fernanda S. N. S. [1 ]
Sangenis, Luiz Henrique C. [1 ]
Hasslocher-Moreno, Alejandro M. [1 ]
机构
[1] Fundacao Oswaldo Cruz, Evandro Chagas Natl Inst Infect Dis, Rio De Janeiro, RJ, Brazil
[2] Natl Inst Cardiol, Dept Res & Educ, Rio De Janeiro, RJ, Brazil
[3] Aloysio de Castro State Inst Cardiol, Ctr Cardiol & Exercise, Rio De Janeiro, RJ, Brazil
[4] Univ Fed Rio de Janeiro, Inst Collect Hlth, Rio De Janeiro, RJ, Brazil
[5] Univ Estado Rio De Janeiro, Inst Social Med, Rio De Janeiro, RJ, Brazil
[6] Naval Acad Brazilian Navy, Dept Phys Educ & Sports, Rio De Janeiro, RJ, Brazil
[7] Univ Estado Rio De Janeiro, Inst Phys Educ & Sports, Rio De Janeiro, RJ, Brazil
[8] Fed Univ Jequitinhonha & Mucuri Valleys, Phys Therapy Dept, Diamantina, MG, Brazil
[9] Univ Fed Rio de Janeiro, Fac Phys Therapy, Sch Med, Rio De Janeiro, RJ, Brazil
[10] Univ Fed Rio de Janeiro, Fac Pharm, Rio De Janeiro, RJ, Brazil
[11] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD USA
关键词
physical activity; exercise training; mental health; fitness; Chagas disease; quality of life; QUALITY-OF-LIFE; BIOELECTRICAL-IMPEDANCE ANALYSIS; BRAZILIAN PORTUGUESE VERSION; CARDIAC REHABILITATION; EUROPEAN ASSOCIATION; FUNCTIONAL-CAPACITY; PHYSICAL-ACTIVITY; AMERICAN SOCIETY; HEART-FAILURE; ADULTS;
D O I
10.3389/fmed.2022.1087188
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: Chagas 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 design: The 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 x 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. Conclusion: The 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.
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页数:12
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