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Completed

NCT Number: NCT04647617

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.

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.

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Key information

Conditions

Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yu-Hsuan Chien

Kaohsiung City, 831, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 50 ~80 years
  • T2DM
  • Physician and check Calf circumference (M: <34 cm, F: <33 cm)、handgrip strength (M: <28 kg, F: <18 kg)

Exclusion criteria

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

Treatment and study plan

Quantitative weight -bearing and report exercise sign data every weekly

Behavioral

keep their normal live style

Other names: Self-manage

Primary outcomes

  1. HbA1c level

    Time frame: up to 12 week of invention

    follow blood glucose control

  2. muscle strength

    Time frame: up to 12 weeks of intervention

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

  3. muscle mass

    Time frame: up to 12 weeks of invention

    Use BIA(Bioelectrical impedance analysis)follow muscle mass,

  4. 5-time chair stand test

    Time frame: up to 12 weeks of invention

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

Secondary outcomes

  1. WHOQOL-BREF World Health Organization Quality of Life Taiwan version

    Time frame: up to 12 week of invention

    follow T2DM with pre-sarcopenia quality of life. The Questionnaire include four domain: psychological domain, social domain, environment domain and Taiwan local domain.This questionnaire scale higher is more better

    follow T2DM with pre-sarcopenia

Sponsors and collaborators

Lead sponsor

Yu- Hsuan Chien

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 1, 2020
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.