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.
Competing Interests: Declarations. Ethics approval and consent to participate {24}: The study was approved by the Human Research Ethics Committee of the Universidade Federal de Santa Catarina (CEPSH/UFSC), with the original ethical approval document registered under number 6.735.640 and attached as an additional file. Also registered in the ReBEC (RBR-10fwqmfy), making it possible to monitor and update the project. It will follow the current guidelines and standards for carrying out research involving human beings, according to the resolution of the National Health Council (CNS) 466/2012. Participants will be informed about the objectives of the research, will give written consent to the research, and will be informed of the option to withdraw from the study at any time. Additionally, participants will receive an individual report with their results after the project is completed. Consent for publication {32}: All participants in the trial provided informed, written consent using institutional review board-approved consent forms. No identifying images or other personal or clinical details of participants are presented here, nor will they be included in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author upon request. Competing interests {28}: The authors declare that they have no competing interests.
(© 2024. The Author(s).)