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Evaluate the Effect of Remote Exercise Intervention on Blood Glucose Control and Physical Fitness in T2DM Patients

2026年6月24日 更新者:Sichuan Academy of Medical Sciences

A 12 Weeks Clinical Trail to Evaluate the Effect of Remote Exercise Intervention on Blood Glucose Control and Physical Fitness in T2DM Patients

The intervention group received 12 weeks of continuous remote intervention combined with health education. The control group only received 12 weeks of continuous health education, and the content and frequency were the same as those of the management group. Both groups received instruction at the beginning of the intervention. The intervention group was given priority to continuous walking/running combined with aerobic exercise and swimming. Five to seven sessions per week for 45 minutes each session. Acclimatizations were performed at an intensity of 40%-49% reserve oxygen uptake (VO2R) from weeks 1 to 4, and exercise was performed at an intensity of 50%-59% VO2R from weeks 5 to 12. 5 minutes each of preparation and grooming activities (including joint movement and stretching) for each exercise. Combined with incremental load resistance exercise 2-3 times a week, 8 movements, 2-3 groups each time, repeated 8-10 times/group, with a 2-min rest between groups. The heart rate, RPE (12-13, "fairly easy" to "somewhat laborious") and exercise bracelet were used to monitor the intensity and amount of exercise. The exercise intervention was usually delivered 1-2 h after a meal. The daily medical supervision in the process of management implementation was carried out by trained sports managers through the doctor terminal of "exercise assistant" to collect and monitor the data of the study subjects.

研究概览

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Wanjing Chen, MPH(Master of Public Health)
  • 电话号码:0086 13980605563
  • 邮箱:270746867@qq.com

学习地点

    • Sichuan
      • Chengdu、Sichuan、中国、610000
        • 招聘中
        • Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC)ospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

(1) Both gender, age from 40 to 69 years old. (2) Meeting the diagnostic criteria for type 2 diabetes in China. (3) HbA1c is within 6.5%-7 .0% and no medication is taken. (4) Newly diagnosed with diabetes or the duration of the disease is no more than 5 years. (5) Possessing general exercise capacity and no obvious diseases in the muscle and osteoarticular systems. (6) The exercise risk is evaluated as medium or low risk through the PAR-Q+ questionnaire. (7) No contraindications to exercise tests. (8) Willing to adopt intensifed lifestyle intervention and complete the entire research process.

Exclusion Criteria:

(1) T1DM patients, autoimmune diabetes and special types of diabetes, including hypercortisolism, growth hormone tumor, glucagonoma and some special types of diabetes caused by genetic factors; (2) pregnant or lactating women; (3) regular use of antidiabetic drugs or insulin in the past three months; (4) fasting blood glucose level > 16.7 mmol/L; (5) recurrent hypoglycemia; (6) a history of acute diabetic complications, including diabetic ketoacidosis, hyperosmolar hyperglycemia, and lactic acidosis; (7) a history of severe chronic microvascular or macrovascular complications; (8) diseases that may be exacerbated by exercise or impair exercise efciency, such as uncontrolled hypertension, hyperthyroidism, osteoarthritis or hypokalemia; (9) unable to use smart phones or wearable smart devices independently; (10) communication or motor dysfunction; (11) Patients with severe chronic diseases could not participate in the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Remote Exercise Management
Participants receive 12-week personalized remote exercise intervention (aerobic + resistance) based on FITT-VP principles, monitored via wearable devices, along with standard health education.
Participants in this arm receive a 12-week personalized remote exercise program based on the FITT-VP principle (Frequency: 5-7 days/week; Intensity: 40-59% VO₂R; Time: 45 min/session + 5-min warm-up/cool-down; Type: aerobic walking/jogging plus resistance training with elastic bands twice weekly). Exercise is monitored via wearable devices and a mobile APP , with feedback and adjustments by trained exercise managers. All participants also receive standard diabetes health education (same content and frequency as the control group).
12-week standard diabetes health education (medical knowledge, diet/exercise advice, complications, mental health) with same frequency/content as experimental group, but without remote exercise.
其他:Education
Health education on DM and Exercise
12-week standard diabetes health education (medical knowledge, diet/exercise advice, complications, mental health) with same frequency/content as experimental group, but without remote exercise.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in glycemic control
大体时间:Baseline and 12 weeks
Fasting plasma glucose (FPG), 2-hour post-load glucose, and glycated hemoglobin (HbA1c) will be measured at baseline and after 12 weeks of intervention to assess glycemic control. Changes from baseline will be compared between the exercise and control groups.
Baseline and 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2026年8月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年6月24日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年6月30日

上次提交的符合 QC 标准的更新

2026年6月24日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • SichuanAMS-2023QN15
  • 2023QN15 (其他赠款/资助编号:Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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