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.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2025-01-08 DOI:10.1186/s13063-024-08660-2
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
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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.

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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。
背景:体育锻炼在2型糖尿病治疗(T2D)中至关重要,由于其物理特性和代谢、功能、心血管和神经肌肉的益处,在水生环境中训练似乎是一个很有前途的选择。在水、旱地训练环境下的联合训练研究较少,特别是长期干预研究。因此,本研究旨在探讨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、双平行臂比较临床试验。患有T2D的参与者,男女,年龄在45 - 80岁之间,将被随机分为两组(水上联合训练(AQUA)和旱地联合训练(LAND)),每周进行三次有氧和阻力联合训练,交替进行,持续24周。有氧训练将采用连续的和金字塔式的方法,以线性的运动强度和持续时间进行。强度将由额定的努力感知(博格量表6至20)来规定。阻力训练将分别在水环境和旱地环境中进行躯干、上肢和下肢最大速度和目标重复区训练,以线性剂量递增的方式进行多组训练。在训练前、12周和24周后,将进行生化分析、功能能力、最大肌肉力量、身体成分评估、心血管测量,并使用问卷评估心理、认知、睡眠质量和生活质量。在整个24周内,还将进行训练负荷日期和急性毛细血管血糖和血压测量。数据将使用SPSS(29.0)统计软件包进行分析,采用0.05的显著性水平。对于组内和组间比较,将应用广义估计方程,并通过意向治疗和采用Bonferroni事后检验的协议进行分析。讨论:所获得的结果可提供见解,以增进对水生和旱地环境对各种健康结果的益处的了解,以及对培训的急性方面和安全考虑的了解。此外,这可以支持干预策略的发展,以优化T2D的管理。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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
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.
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