远程监督家庭运动方案对 2 型糖尿病患者的心脏代谢、功能和心理社会影响（RED 研究）：一项随机临床试验的研究方案。
Cardiometabolic, functional, and psychosocial effects of a remotely supervised home-based exercise program in individuals with type 2 diabetes (RED study): study protocol for a randomized clinical trial.
机构信息
Federal University of Pelotas, Pelotas, Brazil.
Federal University of Santa Catarina, Florianópolis, Brazil.
出版信息
Trials. 2023 Oct 19;24(1):679. doi: 10.1186/s13063-023-07704-3.
BACKGROUND
Type 2 diabetes mellitus (T2D) is a serious global health problem, and exercise is considered an essential non-pharmacological tool in T2D prevention and treatment. During periods of social isolation experienced by the COVID-19 pandemic, home-based exercise programs were strongly recommended as a strategy to facilitate exercise practice and reduce the negative impacts of social isolation. Remotely supervised exercise stands out as an easily accessible strategy after the pandemic, as it is a tool that aims to facilitate access to exercise by this population. The purpose of the RED study is to verify the effects of a remotely supervised home-based exercise program compared to a control group on cardiometabolic, functional, and psychosocial outcomes in patients with T2D.
METHODS
Participants are randomized into the control group (CG) and the intervention group (IG). Participants allocated to the CG receive recommendations for the practice of physical activity based on information from chapters of the Physical Activity Guide for the Brazilian Population, while the IG will perform a 12-week home-based exercise program supervised remotely by video call. The intervention has a weekly frequency of two sessions per week on non-consecutive days during the first 6 weeks and three sessions per week on non-consecutive days for the remaining 6 weeks. The RED study has HbA1c as the primary outcome, and the participants' cardiometabolic, functional, and psychosocial parameters are assessed at baseline (week 0) and post-intervention (week 13).
DISCUSSION
Expected results of the proposed study will provide the knowledge base of health professionals and deliver more evidence for a growing area, i.e., home-based exercise and T2D. Additionally, this protocol aims to verify and demonstrate whether this program can be accessible and effective for different health outcomes in patients with T2D.
TRIAL REGISTRATION
The RED study protocol was prospectively registered at ClinicalTrials.gov (NCT05362071). Date registered April 6, 2022. https://clinicaltrials.gov/ct2/show/NCT05362071 .
背景
2 型糖尿病（T2D）是一个严重的全球性健康问题，运动被认为是 T2D 预防和治疗的重要非药物手段。在 COVID-19 大流行期间，社会隔离期间，强烈推荐家庭运动计划作为促进运动实践和减轻社会隔离负面影响的策略。大流行后，远程监督运动作为一种易于获得的策略脱颖而出，因为它是一种旨在促进该人群进行运动的工具。RED 研究的目的是验证远程监督的家庭运动计划与对照组相比对 T2D 患者的心脏代谢、功能和心理社会结局的影响。
方法
参与者被随机分为对照组（CG）和干预组（IG）。CG 组接受基于《巴西人口体育活动指南》章节的体育活动建议，IG 组将进行为期 12 周的远程监督家庭运动计划。在最初的 6 周内，每周进行两次非连续日的运动，在接下来的 6 周内，每周进行三次非连续日的运动。干预组的干预时间为每周两次，非连续日进行，持续 6 周，然后每周三次，非连续日进行，持续 6 周。RED 研究以糖化血红蛋白（HbA1c）为主要结局，在基线（第 0 周）和干预后（第 13 周）评估参与者的心脏代谢、功能和心理社会参数。
讨论
拟议研究的预期结果将为健康专业人员提供知识基础，并为家庭运动和 T2D 这一不断发展的领域提供更多证据。此外，该方案旨在验证和证明该方案是否对 T2D 患者的不同健康结果具有可及性和有效性。
试验注册
RED 研究方案前瞻性地在 ClinicalTrials.gov 注册（NCT05362071）。注册日期为 2022 年 4 月 6 日。https://clinicaltrials.gov/ct2/show/NCT05362071。
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