TY - JOUR
T1 - Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study)
T2 - A study protocol for a randomized clinical trial
AU - Mediano, Mauro F.F.
AU - Ribeiro, Leonardo G.
AU - Silva, Rudson S.
AU - Xavier, Isis G.G.
AU - Vieira, Marcelo C.
AU - Gonçalves, Tatiana R.
AU - Paravidino, Vitor B.
AU - Borges, Juliana P.
AU - Rodrigues Junior, Luiz Fernando
AU - Costa, Henrique S.
AU - Reis, Michel S.
AU - Liporagi-Lopes, Livia C.
AU - Martinez-Amezcua, Pablo
AU - Silva, Paula S.
AU - Sperandio Da Silva, Gilberto M.
AU - Sousa, Andrea S.
AU - Holanda, Marcelo T.
AU - Veloso, Henrique H.
AU - Carneiro, Fernanda M.
AU - Mazzoli-Rocha, Flavia
AU - Costa, Andrea R.
AU - Saraiva, Roberto M.
AU - Mendes, Fernanda S.N.S.
AU - Sangenis, Luiz Henrique C.
AU - Hasslocher-Moreno, Alejandro M.
N1 - Funding Information:
This present study was partially funded by grant number E-26/201.436/2021 from Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro—FAPERJ (MM).
Publisher Copyright:
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.
PY - 2023/1/6
Y1 - 2023/1/6
N2 - 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 × 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. Clinical trial registration: [https://ensaiosclinicos.gov.br/rg/RBR-10yxgcr9/], identifier [U1111-1263-0153].
AB - 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 × 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. Clinical trial registration: [https://ensaiosclinicos.gov.br/rg/RBR-10yxgcr9/], identifier [U1111-1263-0153].
KW - Chagas disease
KW - exercise training
KW - fitness
KW - mental health
KW - physical activity
KW - quality of life
UR - http://www.scopus.com/inward/record.url?scp=85146809923&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85146809923&partnerID=8YFLogxK
U2 - 10.3389/fmed.2022.1087188
DO - 10.3389/fmed.2022.1087188
M3 - Article
C2 - 36687410
AN - SCOPUS:85146809923
SN - 2296-858X
VL - 9
JO - Frontiers in Medicine
JF - Frontiers in Medicine
M1 - 1087188
ER -