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临床试验/NCT06145542
NCT06145542已完成不适用

Sequences of Aerobic and Resistance Exercise in Training and Their Effects on Cardio-metabolic Functions Among Type 2 Diabetes Patients - a Randomized Study

Zhejiang University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Fasting Glucose at Baseline

研究概览

简要总结

Aerobic exercise and resistance exercise are two types of exercise commonly used in physical conditioning. Compared to aerobic exercise, a combination of aerobic and resistance exercise has been linked to a greater reduction in hemoglobin A1c (HbA1c) among patients with type 2 diabetes (T2D). However, it is not clear that in a concurrent aerobic-resistance training session, whether the orders of the two types of exercise could act differently in glucose metabolism. This randomized trial aims to investigate the effect of the sequence of exercise modalities (aerobic-resistance vs resistance-aerobic in a training session) on glycemic control among T2D patients following an 8-wk intervention period.

详细描述

Objectives:

This randomized study aims to explore the effects of aerobic and resistance training sequences on glycemic control among type 2 diabetes (T2D) patients through an 8-wk combined aerobic and resistance exercise training program.

Study Population:

A total of 56 participants with T2D aged 50-70 years (sex ratio approximately 1:1) with a course of type 2 diabetes of more than one year are included. Participants are residents of Nanjing Municipality, Jiangsu Province, China. Participants are recruited from the outpatients at Maigaoqiao Community Health Service Center, Qixia District, Nanjing, China or through online advertisement published on the official social media (WeChat) channels of the Health Service Center.

Randomization:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 50-70 years;
  • •Type 2 diabetes diagnosed as: random blood glucose ≥11.1mmol/L (200mg/dL) or fasting blood glucose ≥7.0mmol/L (126mg/L) or oral glucose tolerance test (2h) ≥11.1mmol/L (200mg/dL) or glycated hemoglobin (HbA1c) ≥ 6.5%;
  • •The course of type 2 diabetes lasted for one year or longer;
  • •Willing to participate and sign the informed consent form voluntarily

排除标准

  • •Type 1 diabetes;
  • •Fasting blood glucose (FBG)>16.7mmol/L;
  • •Severe complications of diabetes such as acute infection, diabetic ketoacidosis, and plantar lesions;
  • •Severe kidney disease, cardiovascular and cerebrovascular diseases as identified by a specialist;
  • •Musculoskeletal, neurological, psychiatric or other disorders which limit the ability to exercise as identified by a specialist;
  • •Doing physical exercise regularly (≥ 3 times per week, at least 1 hour per session of moderate to vigorous activities);
  • •Currently under dietary program for weight loss;
  • •Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at rest;
  • •Abnormal electrocardiogram (rest and exercise);
  • •Other comorbidities or medications irrelevant to diabetes treatment that may influence glycemia during the past 6 months

研究组 & 干预措施

AR group

Experimental

aerobic exercise then resistance exercise in all training sessions

干预措施: AR group: aerobic training before resistance training (Behavioral)

RA group

Active Comparator

resistance exercise then aerobic exercise in all training sessions

干预措施: RA group: resistance exercise before aerobic exercise (Behavioral)

结局指标

主要结局

Fasting Glucose at Baseline

时间窗: At week 0, within 7 days before the intervention starts

blood glucose level following overnight (12-h) fasting

Fasting Glucose at Follow-up

时间窗: At week 9, within 7 days after the intervention completes

blood glucose level following overnight (12-h) fasting

Hemoglobin A1c (HbA1c) at Baseline

时间窗: At baseline, within 7 days before the intervention starts

At baseline, the HbA1c level in blood among all participants

Hemoglobin A1c (HbA1c) at Follow-up

时间窗: At week 9, within 7 days after the completion of the 8-week intervention

After intervention, the HbA1c level in blood among all participants

Continuous Glucose Monitoring at Baseline (Mean, sd, Lage)

时间窗: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (mean, sd, lage)

At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

Continuous Glucose Monitoring at Baseline (Coefficient of Variation)

时间窗: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (cv)

At baseline, 14-day continuous glucose monitoring including mean glucose value, standard deviation (SD) of the glucose values, coefficient of variation (CV) of relative standard deviation, LAGE, TIR, TAR, TBR

Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr)

时间窗: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (tir, tar, tbr)

At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage)

时间窗: at week 8-9

After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

Continuous Glucose Monitoring at Follow-up (Coefficient of Variation)

时间窗: at week 8-9

At baseline, 14-day continuous glucose monitoring including mean glucose value, standard deviation (SD) of the glucose values, coefficient of variation (CV) of relative standard deviation, LAGE, TIR, TAR, TBR

Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr)

时间窗: at week 8-9

After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

次要结局

未报告次要终点

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiao Tan

Associate Professor

Zhejiang University

研究点 (1)

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