Larissa Dos Santos Leonel, Ingrid Alessandra Victoria Wolin, Angélica Danielevicz, Mabel Diesel, Marina Isolde Constantini, João Batista de Oliveira Junior, Allana Andrade Souza, Thaís Reichert, João Gabriel Silveira-Rodrigues, Danusa Dias Soares, Marcelo Fernando Ronsoni, Simone Van De Sande Lee, Alex Rafacho, Guilherme Fleury Fina Speretta, Karla Siqueira Lottermann, Josefina Bertoli, Alexandre Pastoris Muller, Aline Mendes Gerage, Cíntia de La Rocha Freitas, Rodrigo Sudatti Delevatti
{"title":"2型糖尿病管理的24周水上和陆地不同环境的联合训练(水生和陆地运动治疗糖尿病-ALED):一项随机临床试验方案。","authors":"Larissa Dos Santos Leonel, Ingrid Alessandra Victoria Wolin, Angélica Danielevicz, Mabel Diesel, Marina Isolde Constantini, João Batista de Oliveira Junior, Allana Andrade Souza, Thaís Reichert, João Gabriel Silveira-Rodrigues, Danusa Dias Soares, Marcelo Fernando Ronsoni, Simone Van De Sande Lee, Alex Rafacho, Guilherme Fleury Fina Speretta, Karla Siqueira Lottermann, Josefina Bertoli, Alexandre Pastoris Muller, Aline Mendes Gerage, Cíntia de La Rocha Freitas, Rodrigo Sudatti Delevatti","doi":"10.1186/s13063-024-08660-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Physical exercise is crucial in type 2 diabetes management (T2D), and training in the aquatic environment seems to be a promising alternative due to its physical properties and metabolic, functional, cardiovascular, and neuromuscular benefits. Research on combined training in aquatic and dry-land training environments is scarce, especially in long-term interventions. Thus, this study aims to investigate the effects of combined training in both environments on health outcomes related to the management of T2D patients.</p><p><strong>Methods: </strong>This is a randomized, unicentric, single-blinded, comparator clinical trial with two parallel arms. Participants with T2D, of both sexes, aged at 45 to 80 years old, will be randomized into two groups (aquatic combined training (AQUA) and dry-land combined training (LAND)), both performing combined aerobic and resistance training three times a week on alternate days for 24 weeks. Aerobic training will be performed using continuous and pyramidal methods, with linear exercise intensity and duration progression. Intensity will be prescribed by rated effort perception (Borg scale 6 to 20). Resistance training will be performed using exercise for the trunk, upper and lower limbs maximum speed, and target repetition zone in aquatic and dry-land environments, respectively, using multiple sets in a linear dosage progression. Before, at 12 weeks, and after the 24 weeks of training, biochemical analyses, functional capacity, maximum muscle strength, body composition assessments, cardiovascular measures, and the administration of questionnaires to assess mental, cognitive, sleep quality, and quality of life will be conducted. Throughout the 24 weeks, the training load date and acute capillary glucose and blood pressure measurements will also be conducted. The data will be analyzed using the SPSS (29.0) statistical package, using a significance level of 0.05. For intra- and inter-group comparisons, generalized estimating equations will be applied and analyzed by intention-to-treat and per-protocol adopting the Bonferroni post hoc test.</p><p><strong>Discussion: </strong>The obtained results may provide insights to enhance understanding of the benefits of the aquatic and dry-land environment on various health outcomes, as well as acute aspects and safety considerations of the training. Moreover, this could support the development of intervention strategies to optimize the T2D management.</p><p><strong>Trial registration: </strong>Brazilian Clinical Trial Registry (ReBEC) RBR-10fwqmfy. 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Research on combined training in aquatic and dry-land training environments is scarce, especially in long-term interventions. Thus, this study aims to investigate the effects of combined training in both environments on health outcomes related to the management of T2D patients.</p><p><strong>Methods: </strong>This is a randomized, unicentric, single-blinded, comparator clinical trial with two parallel arms. Participants with T2D, of both sexes, aged at 45 to 80 years old, will be randomized into two groups (aquatic combined training (AQUA) and dry-land combined training (LAND)), both performing combined aerobic and resistance training three times a week on alternate days for 24 weeks. Aerobic training will be performed using continuous and pyramidal methods, with linear exercise intensity and duration progression. Intensity will be prescribed by rated effort perception (Borg scale 6 to 20). Resistance training will be performed using exercise for the trunk, upper and lower limbs maximum speed, and target repetition zone in aquatic and dry-land environments, respectively, using multiple sets in a linear dosage progression. Before, at 12 weeks, and after the 24 weeks of training, biochemical analyses, functional capacity, maximum muscle strength, body composition assessments, cardiovascular measures, and the administration of questionnaires to assess mental, cognitive, sleep quality, and quality of life will be conducted. Throughout the 24 weeks, the training load date and acute capillary glucose and blood pressure measurements will also be conducted. The data will be analyzed using the SPSS (29.0) statistical package, using a significance level of 0.05. 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Twenty-four weeks of combined training in different environments, aquatic and land, in the type 2 diabetes management (Aquatic and Land Exercise for Diabetes -ALED): protocol of a randomized clinical trial.
Background: Physical exercise is crucial in type 2 diabetes management (T2D), and training in the aquatic environment seems to be a promising alternative due to its physical properties and metabolic, functional, cardiovascular, and neuromuscular benefits. Research on combined training in aquatic and dry-land training environments is scarce, especially in long-term interventions. Thus, this study aims to investigate the effects of combined training in both environments on health outcomes related to the management of T2D patients.
Methods: This is a randomized, unicentric, single-blinded, comparator clinical trial with two parallel arms. Participants with T2D, of both sexes, aged at 45 to 80 years old, will be randomized into two groups (aquatic combined training (AQUA) and dry-land combined training (LAND)), both performing combined aerobic and resistance training three times a week on alternate days for 24 weeks. Aerobic training will be performed using continuous and pyramidal methods, with linear exercise intensity and duration progression. Intensity will be prescribed by rated effort perception (Borg scale 6 to 20). Resistance training will be performed using exercise for the trunk, upper and lower limbs maximum speed, and target repetition zone in aquatic and dry-land environments, respectively, using multiple sets in a linear dosage progression. Before, at 12 weeks, and after the 24 weeks of training, biochemical analyses, functional capacity, maximum muscle strength, body composition assessments, cardiovascular measures, and the administration of questionnaires to assess mental, cognitive, sleep quality, and quality of life will be conducted. Throughout the 24 weeks, the training load date and acute capillary glucose and blood pressure measurements will also be conducted. The data will be analyzed using the SPSS (29.0) statistical package, using a significance level of 0.05. For intra- and inter-group comparisons, generalized estimating equations will be applied and analyzed by intention-to-treat and per-protocol adopting the Bonferroni post hoc test.
Discussion: The obtained results may provide insights to enhance understanding of the benefits of the aquatic and dry-land environment on various health outcomes, as well as acute aspects and safety considerations of the training. Moreover, this could support the development of intervention strategies to optimize the T2D management.
Trial registration: Brazilian Clinical Trial Registry (ReBEC) RBR-10fwqmfy. Registered on April 16, 2024.
期刊介绍:
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.