Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2023 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/56961 |
Resumo: | 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). |
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Mediano, Mauro F. F.Ribeiro, Leonardo G.Silva, Rudson S.Xavier, Isis G. G.Vieira, Marcelo C.Gonçalves, Tatiana R.Paravidino, Vitor B.Borges, Juliana P.Rodrigues Junior, Luiz FernandoCosta, Henrique S.Reis, Michel S.Liporagi-Lopes, Livia C.Martinez-Amezcua, PabloSilva, Paula S.Sperandio Da Silva, Gilberto M.Sousa, Andrea S.Holanda, Marcelo T.Veloso, Henrique H.Carneiro, Fernanda M.Mazzoli-Rocha, FlaviaCosta, Andrea S.Saraiva, Roberto M.Mendes, Fernanda S. N. S.Sangenis, Luiz Henrique C.Hasslocher-Moreno, Alejandro Marcel2023-02-09T01:51:39Z2023-02-09T01:51:39Z2023MEDIANO, Mauro F. F. et al. 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, v. 9, p. 1-12, Jan. 6 2023.2296-858Xhttps://www.arca.fiocruz.br/handle/icict/5696110.3389/fmed.2022.1087188This 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).Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil / National Institute of Cardiology. Department of Research and Education. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil / Institute of Cardiology. Center for Cardiology and Exercise, Aloysio de Castro State. Rio de Janeiro, RJ, Brazil.Federal University of Rio de Janeiro. Institute of Collective Health. Rio de Janeiro, RJ, Brazil.State University of Rio de Janeiro. Institute of Social Medicine. Rio de Janeiro, RJ, Brazil / Naval Academy Brazilian Navy. Department of Physical Education and Sports. Rio de Janeiro, RJ, Brazil.State University of Rio de Janeiro. Institute of Physical Education and Sports. Rio de Janeiro, RJ, Brazil.National Institute of Cardiology. Department of Research and Education. Rio de Janeiro, RJ, Brazil.Federal University of Jequitinhonha and Mucuri Valleys. Physical Therapy Department. Diamantina, DF, Brazil.Federal University of Rio de Janeiro. School of Medicine. Faculty of Physical Therapy. Rio de Janeiro, RJ, Brazil.Federal University of Rio de Janeiro. Faculty of Pharmacy. Rio de Janeiro, RJ, Brazil.Johns Hopkins Bloomberg School of Public Health. Department of Epidemiology. Baltimore, USA.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.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 followup. 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].engFrontiers Media S.A.Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlePhysical activityExercise trainingMental healthFitnessChagas diseaseQuality of lifeinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/56961/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALMediano_Mauro_etal_INI_2023.pdfMediano_Mauro_etal_INI_2023.pdfapplication/pdf905374https://www.arca.fiocruz.br/bitstream/icict/56961/3/Mediano_Mauro_etal_INI_2023.pdf6e947c4f73d04275a3f56205aecde435MD53icict/569612023-03-08 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| dc.title.en_US.fl_str_mv |
Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial |
| title |
Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial |
| spellingShingle |
Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial Mediano, Mauro F. F. Physical activity Exercise training Mental health Fitness Chagas disease Quality of life |
| title_short |
Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial |
| title_full |
Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial |
| title_fullStr |
Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial |
| title_full_unstemmed |
Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial |
| title_sort |
Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial |
| author |
Mediano, Mauro F. F. |
| author_facet |
Mediano, Mauro F. F. Ribeiro, Leonardo G. Silva, Rudson S. Xavier, Isis G. G. Vieira, Marcelo C. Gonçalves, Tatiana R. Paravidino, Vitor B. Borges, Juliana P. Rodrigues Junior, Luiz Fernando Costa, Henrique S. Reis, Michel S. Liporagi-Lopes, Livia C. Martinez-Amezcua, Pablo Silva, Paula S. Sperandio Da Silva, Gilberto M. Sousa, Andrea S. Holanda, Marcelo T. Veloso, Henrique H. Carneiro, Fernanda M. Mazzoli-Rocha, Flavia Costa, Andrea S. Saraiva, Roberto M. Mendes, Fernanda S. N. S. Sangenis, Luiz Henrique C. Hasslocher-Moreno, Alejandro Marcel |
| author_role |
author |
| author2 |
Ribeiro, Leonardo G. Silva, Rudson S. Xavier, Isis G. G. Vieira, Marcelo C. Gonçalves, Tatiana R. Paravidino, Vitor B. Borges, Juliana P. Rodrigues Junior, Luiz Fernando Costa, Henrique S. Reis, Michel S. Liporagi-Lopes, Livia C. Martinez-Amezcua, Pablo Silva, Paula S. Sperandio Da Silva, Gilberto M. Sousa, Andrea S. Holanda, Marcelo T. Veloso, Henrique H. Carneiro, Fernanda M. Mazzoli-Rocha, Flavia Costa, Andrea S. Saraiva, Roberto M. Mendes, Fernanda S. N. S. Sangenis, Luiz Henrique C. Hasslocher-Moreno, Alejandro Marcel |
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author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Mediano, Mauro F. F. Ribeiro, Leonardo G. Silva, Rudson S. Xavier, Isis G. G. Vieira, Marcelo C. Gonçalves, Tatiana R. Paravidino, Vitor B. Borges, Juliana P. Rodrigues Junior, Luiz Fernando Costa, Henrique S. Reis, Michel S. Liporagi-Lopes, Livia C. Martinez-Amezcua, Pablo Silva, Paula S. Sperandio Da Silva, Gilberto M. Sousa, Andrea S. Holanda, Marcelo T. Veloso, Henrique H. Carneiro, Fernanda M. Mazzoli-Rocha, Flavia Costa, Andrea S. Saraiva, Roberto M. Mendes, Fernanda S. N. S. Sangenis, Luiz Henrique C. Hasslocher-Moreno, Alejandro Marcel |
| dc.subject.en.en_US.fl_str_mv |
Physical activity Exercise training Mental health Fitness Chagas disease Quality of life |
| topic |
Physical activity Exercise training Mental health Fitness Chagas disease Quality of life |
| description |
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). |
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2023 |
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2023-02-09T01:51:39Z |
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2023-02-09T01:51:39Z |
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2023 |
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MEDIANO, Mauro F. F. et al. 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, v. 9, p. 1-12, Jan. 6 2023. |
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https://www.arca.fiocruz.br/handle/icict/56961 |
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2296-858X |
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10.3389/fmed.2022.1087188 |
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MEDIANO, Mauro F. F. et al. 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, v. 9, p. 1-12, Jan. 6 2023. 2296-858X 10.3389/fmed.2022.1087188 |
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