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临床试验/NCT04647617
NCT04647617已完成不适用

Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.

Yu- Hsuan Chien2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
muscle strength

研究概览

简要总结

According to the International Diabetes Federation (IDF) in 2017 investigator found that the incidence of type 2 diabetes is currently 425 million people aged 20 to 79 in the world, and this data will increase o 629 million at 2045, The etiology of more than 90% is related to aging, it has become a serious challenge to public health.

Sarcopenia is a newly noticed severe syndrome characterized by reduced walking speed, decreased grip strength, and decreased muscle mass. Patients with type 2 diabetes are at risk of sarcopenia and are those with normal blood sugar. One of the main ways to improve the face of sarcopenia is to exercise intensity. By carrying out a gradual training plan instead of using different weights, it will lead to muscle hypertrophy and increase in muscle strength to achieve muscle gain. In view of the fact that the commercially available sandbags are cheap and easy to obtain, the weight is fixed, and the use variability is high, it is expected to introduce quantitative weight-bearing progressive exercises in type 2 diabetes and have symptoms of muscle loss to improve muscle mass, and to control blood sugar. The quality of life can have better benefits.

详细描述

Purpose:This study aim is effectiveness of 12 weeks quantitative weight-bearing progressive exercise training in patients with type 2 diabetes mellitus(T2DM) with pre-sarcopenia promotion muscle strength and blood sugar control.

Hypothesis

After 12 weeks of quantitative sandbag training , the experimental group can have a significant increase in the muscle mass of the upper and lower limbs、grip strength、5-time chair stand test、Lipid profile、glycemic control(HbA1c) and quality of life.

Methods:This study will be a randomized controlled trial. Forty adult diagnosis with T2DM with pre-sarcopenia patient randomly assigned to experimental group and control group. Experimental group wearing 0.5 kg quantitative sandbag 12~15 Repetitions/set X 5 set X 3day. Weight adjustment: After the first month of intervention, if the experimental can perform for more than 20 repetitions/set , we will asked to increase the weight of the sandbag to 1 kg until the end of the experiment Conditions:The effectiveness of 12 weeks quantitative weight-bearing can improvement of Glycemic control and limb muscle strength.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

single

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 50 ~80 years
  • Physician and check Calf circumference (M: <34 cm, F: <33 cm)、handgrip strength (M: <28 kg, F: <18 kg)

排除标准

  • Inability to perform any self -activity
  • DM with lower limb neuropathy, r
  • DM with Retinopathy
  • Foot opening wound
  • Past history even doing limb resistance training;
  • Easy fall down high risk patients

结局指标

主要结局

muscle strength

时间窗: up to 12 weeks of intervention

follow hand grip male.If the hand grip show weakness it mean the worse of muscle strength

HbA1c level

时间窗: up to 12 week of invention

follow blood glucose control

muscle mass

时间窗: up to 12 weeks of invention

Use BIA(Bioelectrical impedance analysis)follow muscle mass,

5-time chair stand test

时间窗: up to 12 weeks of invention

follow low limb muscle strength .The higher number of seconds, it mean the worse the lower limb ability

次要结局

  • WHOQOL-BREF World Health Organization Quality of Life Taiwan version(up to 12 week of invention)

研究者

发起方
Yu- Hsuan Chien
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yu- Hsuan Chien

Chang Gung Memorial Hospital

Chang Gung Memorial Hospital

研究点 (2)

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