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2型糖尿病管理中的24周不同环境(水上和陆地)联合训练(糖尿病的水上和陆地运动-ALED):一项随机临床试验方案

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.

作者信息

Leonel Larissa Dos Santos, Wolin Ingrid Alessandra Victoria, Danielevicz Angélica, Diesel Mabel, Constantini Marina Isolde, de Oliveira Junior João Batista, Souza Allana Andrade, Reichert Thaís, Silveira-Rodrigues João Gabriel, Soares Danusa Dias, Ronsoni Marcelo Fernando, Van De Sande Lee Simone, Rafacho Alex, Speretta Guilherme Fleury Fina, Lottermann Karla Siqueira, Bertoli Josefina, Muller Alexandre Pastoris, Gerage Aline Mendes, de La Rocha Freitas Cíntia, Delevatti Rodrigo Sudatti

机构信息

Department of Physical Education, Sports Center, Federal University of Santa Catarina, University Campus Trindade, Florianópolis, Santa Catarina, 88040-900, Brazil.

Department of Physical Education, Federal University of Paraná, University Campus Jardim das Américas, Curitiba, Paraná, 81531-980, Brazil.

出版信息

Trials. 2025 Jan 8;26(1):12. doi: 10.1186/s13063-024-08660-2.

Abstract

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.

摘要

背景

体育锻炼在2型糖尿病管理(T2D)中至关重要,由于其物理特性以及代谢、功能、心血管和神经肌肉方面的益处,在水环境中进行训练似乎是一种很有前景的选择。关于在水和陆地训练环境中进行联合训练的研究很少,尤其是在长期干预方面。因此,本研究旨在调查两种环境下的联合训练对与T2D患者管理相关的健康结果的影响。

方法

这是一项随机、单中心、单盲、有对照的临床试验,有两个平行组。年龄在45至80岁的T2D患者,无论男女,将被随机分为两组(水上联合训练(AQUA)组和陆地联合训练(LAND)组),两组均每周隔天进行三次有氧和阻力联合训练,共24周。有氧训练将采用持续和金字塔式方法进行,运动强度和持续时间呈线性进展。强度将根据主观用力感觉(Borg量表6至20)来规定。阻力训练将分别在水和陆地环境中针对躯干、上肢和下肢进行最大速度运动,并在各自环境中采用线性剂量递增的多组训练来达到目标重复次数范围。在训练前、12周时和24周训练结束后,将进行生化分析、功能能力评估、最大肌肉力量测试、身体成分评估、心血管测量,并发放问卷以评估心理、认知、睡眠质量和生活质量。在整个24周期间,还将记录训练负荷数据以及测量即时毛细血管血糖和血压。数据将使用SPSS(29.0)统计软件包进行分析,显著性水平设定为0.05。对于组内和组间比较,将应用广义估计方程,并采用意向性分析和符合方案分析,同时采用Bonferroni事后检验。

讨论

所获得的结果可能有助于深入了解水和陆地环境对各种健康结果的益处,以及训练的即时影响和安全注意事项。此外,这可以支持制定优化T2D管理的干预策略。

试验注册

巴西临床试验注册中心(ReBEC)RBR-10fwqmfy。于2024年4月16日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57c/11716115/0b3839b504d0/13063_2024_8660_Fig1_HTML.jpg

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